Quality Control Past Paper PDF

**Course Code**: **IT 314 -- QUALITY CONTROL** **Course**: All THIRD YEAR STUDENTS **Course Description:** Focuses on how organization manage quality in a competitive market-based regardless of the nature of the industry; principles of quality, cost of quality, inspection and receiving, audits, co...

**Course Code**: **IT 314 -- QUALITY CONTROL** **Course**: All THIRD YEAR STUDENTS **Course Description:** Focuses on how organization manage quality in a competitive market-based regardless of the nature of the industry; principles of quality, cost of quality, inspection and receiving, audits, corrective and preventive action system, supplier performance management (SPM), FEMA and control plans, process capability studies, and statistical process control (SPC), measurement system analysis, quality management system (QMS), process involvement methodologies, and creation of a performance dashboard **Topic: SUPPLIER PERFORMANCE MANAGEMENT** **Week: \# 10-11** **CONTENT** **[Topic \#1: Acceptance Sampling and Process Control]** ***Acceptance sampling*** is the third branch of statistical quality control that refers to the process of randomly inspecting a certain number of items from a lot or batch in order to decide whether to accept or reject the entire batch. What makes acceptance sampling different from statistical process control is that acceptance sampling is performed either *before* or *after* the process, rather than during the process. - Acceptance sampling *before* the process involves sampling materials received from a supplier, such as randomly inspecting crates of fruit that will be used in a restaurant, boxes of glass dishes that will be sold in a department store, or metal castings that will be used in a machine shop. - Sampling *after* the process involves sampling finished items that are to be shipped either to a customer or to a distribution center. Examples include randomly testing a certain number of computers from a batch to make sure they meet operational requirements and randomly inspecting snow boards to make sure that they are not defective. **[Topic \#2: Inspection: Ways to Inspect/ How Often]** **Inspection** is an appraisal activity that compares goods or services to a standard. Inspection can occur at three points: **before production**, **during production**, and **after production**. - The logic of checking conformance **before** production is to make sure that **inputs are acceptable**. - The logic of checking conformance **during** production is to make sure that the **conversion of inputs into outputs is proceeding in an acceptable manner**. - The logic of checking conformance **after** production (actual output) is to make a **final verification of conformance before passing goods on to customers**. - Inspection **before and after** conformance often involves **acceptance sampling procedures.** - Monitoring **during** the production process is referred to as **process control.** Acceptance sampling Process control Acceptance sampling **[How much to Inspect and How Often]** **The amount of inspection can range from no inspection whatsoever to inspection of each item numerous times.** - **Low-cost, high volume items** such as paper clips, roofing nails, and wooden pencils often require **little inspection** because: 1. The cost associated with passing defective items is quite low 2. The processes that produce these items are usually highly reliable, so the defects are rare - **High-cost, low-volume items** that have large costs associated with passing defective products often require **more intensive inspections.** In high-volume systems, **automated inspection** is one option that may be employed. **Example:** Critical components of a manned-flight space vehicle are closely scrutinized because of the risk to human safety and the high cost of mission failure. **The amount of inspection needed is governed by the costs of inspection and the expected costs of passing defective items.** - If inspection activities increases, inspection cost increases, but the costs of undetected defects decreases. - As a rule, operations with a high proportion of human involvement require more inspection effort than mechanical operations, which tend to be more reliable. **The frequency of inspection depends largely on the rate at which a process may go out of control or the number of lots being inspected.** - A **stable** process will require only **infrequent checks**. - An **unstable process** or one that has **recently given trouble** will require **more frequent checks.** **[Topic \#3: Place of Inspection]** Many operations have numerous possible inspection points. **Because each inspection adds to the cost of the product or service, it is important to restrict inspection efforts to the points where they can do the most good.** A. **In manufacturing, some of the typical points are:** 1. **Raw materials and purchased parts.** There is little sense in paying for goods that do not meet quality standards and in expending time and effort on material that is bad to begin with. 2. **Finished products.** Customer satisfaction and the firm's image are at stake here, and repairing or replacing products in the field is usually much more costly than doing it at the factory. Likewise, the seller is usually responsible for shipping costs on returns, and payments for goods or service may be held up pending delivery of satisfactory goods or remedial service. 3. **Before a costly operation.** The point is not to waste costly labor or machine time on items that are already defective. 4. **Before an irreversible process.** In many cases, items can be reworked up to a certain point; beyond that point they cannot. **For example:** Pottery can be reworked prior to firing. After that, defective pottery must be discarded or sold as seconds at a lower price. 5. **Before a covering process.** Painting, plating, and assemblies often mask defects. B. **In the service sector, inspection points are:** 1. **Incoming purchased materials and supplies** 2. **Personnel** 3. **Service interfaces (ex: service counter)** 4. **Outgoing completed work (ex: repaired appliances)** **[Topic \#4: Centralized versus On-site Inspection]** - Some situations require that **inspections be performed on site.** For example: inspecting the hull of a ship for cracks requires inspectors to visit the ship - At other times, **specialized test can best be performed in a lab.** For example: performing medical tests, analysing food samples, testing metals for hardness, running viscosity test on lubricants **The central issue in the decision concerning on-site or lab inspection is whether the advantages of specialized lab tests are worth the time and interruption needed to obtain the results.** - Reasons for favouring on-site inspection include quicker decisions and avoidance of introduction of extraneous factors (Example: damage or other alteration of samples during transportation to the lab). - On the other hand, specialized equipment and a more favourable test environment (less noise and confusion, lack of vibrations, absence of dust, and no workers "helping" with inspections) offer strong argument for using a lab. **[Topic \#5: Purpose and Importance of Corrective and Preventive Action]** **Purpose/Importance** **The purpose of the corrective and preventive action subsystem is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence.** Verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review, and documenting these activities are essential in dealing effectively with product and quality problems, preventing their recurrence, and preventing or minimizing device failures. One of the most important quality system elements is the corrective and preventive action subsystem. **[Topic \#6: Ten Inspectional Objectives]** 1. **Verify that CAPA system procedure(s) that address the requirements of the quality system regulation have been defined and documented.** Review the firm\'s corrective and preventive action procedure. If necessary, have management provide definitions and interpretation of words or terms such as \"nonconforming product\", \"quality audit\", \"correction\", \"prevention\", \"timely\", and others. It is important to gain a working knowledge of the firm\'s corrective and preventive action procedure before beginning the evaluation of this subsystem. 2. **Determine if appropriate sources of product and quality problems have been identified. Confirm that data from these sources are analyzed to identify existing product and quality problems that may require corrective action.** The firm should have methods and procedures to input product or quality problems into the CAPA subsystem. Product and quality problems should be analyzed to identify product and quality problems that may require corrective action. 3. **Determine if sources of product and quality information that may show unfavorable trends have been identified. Confirm that data from these sources are analyzed to identify potential product and quality problems that may require preventive action.** Determine if the firm is identifying product and quality problems that may require a preventive action. This can be accomplished by reviewing historical records such as trending data, corrective actions, acceptance activities (component history records, process control records, finished device testing, etc.) and other quality system records for unfavorable trends. Review if preventive actions have been taken regarding unfavorable trends recognized from the analysis of product and quality information. Product and quality improvements and use of appropriate statistical process control techniques are evidence of compliance with the preventive action requirement. 4. **Challenge the quality data information system. Verify that the data received by the CAPA system are complete, accurate and timely.** Select one or two quality data sources. Using the sampling tables, review records from the chosen data sources to determine if the data were entered into the CAPA system. In addition, determine whether the data are complete, accurate and entered into the CAPA system in a timely manner. 5. **Verify that appropriate statistical methods are employed (where necessary) to detect recurring quality problems. Determine if results of analyses are compared across different data sources to identify and develop the extent of product and quality problems.** The analysis of product and quality problems should include appropriate statistical and non-statistical techniques. Statistical techniques include Pareto analysis, spreadsheets, and pie charts. Non-statistical techniques include quality review boards, quality review committees and other methods. The analysis of product and quality problems should also include the comparison of problems and trends across different data sources to establish a global, and not an isolated view, of a problem. For example, problems noted in service records should be compared with similar problem trends noted in complaints and acceptance activity information. 6. **Determine if failure investigation procedures are followed. Determine if the degree to which a quality problem or nonconforming product is investigated is commensurate with the significance and risk of the nonconformity. Determine if failure investigations are conducted to determine root cause (where possible). Verify that there is control for preventing distribution of nonconforming product.** Review the firm\'s CAPA procedures for conducting failure investigations. Determine if the procedures include provisions for identifying the failure modes, determining the significance of the failure modes (using tools such as risk analysis), the rationale for determining if a failure analysis should be conducted as part of the investigation, and the depth of the failure analysis. 7. **Determine if appropriate actions have been taken for significant product and quality problems identified from data sources.** Where appropriate, this may include recall actions, changes in acceptance activities for components, in-process and finished devices, etc. Using the sampling tables, select and review significant corrective actions and determine if the change or changes could have extended beyond the action taken. A significant action would be a product or process change to correct a reliability problem or to bring the product into conformance with product specifications. Discuss with the firm their rationale for not extending the action to include additional actions such as changes in component supplier, training, changes to acceptance activities, field action or other applicable actions. Investigators should discuss and evaluate these issues but be careful not to say anything that could be construed as requesting a product recall. 8. **Determine if corrective and preventive actions were effective and verified or validated prior to implementation. Confirm that corrective and preventive actions do not adversely affect the finished device.** Using the selected sample of significant corrective and preventive actions, determine the effectiveness of these corrective or preventive actions. This can be accomplished by reviewing product and quality problem trend results. Determine if there are any similar product or quality problems after the implementation of the corrective or preventive actions. Determine if the firm has verified or validated the corrective or preventive actions to ensure that such actions are effective and do not adversely affect the finished device. 9. **Verify that corrective and preventive actions for product and quality problems were implemented and documented.** Using the sampling tables, select and review records of the most recent corrective or preventive actions (this sample may consist of or include records from the previously selected sample of significant corrective actions). To determine if corrective and preventive actions for product and quality problems and changes have been documented and implemented it may be necessary to view actual processes, equipment, facilities or documentation. 10. **Determine if information regarding nonconforming product and quality problems and corrective and preventive actions has been properly disseminated, including dissemination for management review.** Determine that the relevant information regarding quality problems, as well as corrective and preventive actions, has been submitted for management review. This can be accomplished by determining which records in a recent CAPA event were submitted for management review. Review the raw data submitted for management review and not the actual results of a management review. Review the CAPA (and other procedures if necessary) and confirm that there is a mechanism to disseminate relevant CAPA information to those individuals directly responsible for assuring product quality and the prevention of quality problems. Review information related to product and quality problems that has been disseminated to those individuals directly responsible for assuring product quality and the prevention of quality problems. Using the sample of records from Objective 9 above, confirm that information related to product and quality problems is disseminated to individuals directly responsible for assuring product quality and the prevention of quality problems. **Topic: SUPPLIER PERFORMANCE MANAGEMENT** **Week: \# 12** **Learning Objectives:** **Upon completion of this module, you should be able to:** - Understand the concept of Supplier Performance Management - Communicate the use of scorecard - Develop goals and strategy that are useful in supplier performance management program - Evaluate one's learning **CONTENT** **[Topic \# 01: Concept of Supplier Performance Management]** **Supplier performance management (SPM)** is a business practice that is used to measure, analyze, and manage the supplier's performance in an effort to cut costs, alleviate risks, and drive continuous improvement. The ultimate intent is to identify potential issues and their root causes so that they can be resolved to everyone's benefit as early as possible. **Most companies rely on timely delivery, price reduction and service quality offered by their suppliers in order to gain more profit**, therefore the successful management of supplier performance directly affects the quality of the whole supply chain making it essential to establish an efficient mechanism to enhance it, accelerate its improvement and ensure the quality of services and/or products. **Any company that deploys effective supplier performance management ensures that a supplier's performance meets the expectations defined in the contract and against market norms. Supplier** performance management not only ensures that those benefits identified in the contracting stage are delivered, but that value delivery continues for the life of the contract. **Ultimately, the objective of supplier performance management is to improve the performance of all parties involved in the contract and Service Level Agreement.** **BENEFITS OF SUPPLIER PERFORMANCE MANAGEMENT** 1. Companies can avoid costly and potentially devastating [supply disruptions](https://scm.ncsu.edu/scm-articles/article/how-do-supply-chain-risks-occur-a-managerial-framework-for-reducing-the-impact-of-disruptions-to-the-supply-chain). 2. Companies can reduce overall risk to other adverse scenarios like defects, environmental problems, or safety issues with a supplier's process, materials, or products. 3. Companies that implement successful supplier performance management programs will be better able to spot problems early and begin to implement [corrective actions](https://www.lockheedmartin.com/content/dam/lockheed-martin/aero/documents/scm/Quality-Requirements/Information/Webinar-CorrectiveActionRequest%20Levels-Criteria.pdf) before the problem becomes a big headache or hits the bottom line. 4. Improved collaboration between suppliers that can lead to better coordination and enables the company and supplier to better meet the company's business objectives. 5. Increased efficiency and productivity for the organization as it interacts with its suppliers. 6. Can also let suppliers take initiative to perform tasks like updating their information to ensure that everything is current. 7. Effective supplier performance management is not easy to achieve and takes knowledge or an organization's goals, business processes, structure, and supply base. When it is done well, it can bring significant monetary benefits to a company. **[Topic 02\#: Supplier Performance Management Scorecard]** **A supplier performance scorecard (supplier scorecard)** is a tracking tool used to monitor supplier performance. Supplier scorecards track metrics such as quality, delivery, lead time, price and responsiveness of suppliers over time. Supplier performance professionals use scorecard data to improve supplier relationships. **Supplier Performance Scorecard Dimensions** - financial health (risk of bankruptcy, liquidity, sales, etc) - operational performance (quality, lead times, customer services, etc) - contract compliance - business processes (defect prevention, inspections, etc) - price change year-on-year - negotiator price impact - over-all cost **[Topic \#03: Supplier Performance Management Goals and Strategy]** **Without an alignment between a supplier performance management program and the goals and strategy of the company, the program will be at best ineffective and may result in wasted resources.** The goals of the program should also be tied into the overall spending of the company and should consequently reflect the company's spending and strategic priorities. This means that areas of greater spend and/or greater strategic focus for the company should receive more attention and focus in the program. **FACTORS THAT YOU MUST CONSIDER:** 1. **Metrics to focus on: Key Performance Indicators (KPIs)** are areas that company chooses to measure and manage for the supplier performance management program. There are a wide variety of areas of supplier performance that may be measured. It is important to select the ones that are most important for the organization. These indicators are the direct result of the company's objectives, goals and strategy. 2. **Suppliers to Focus On: High Value and Strategic Suppliers** Another factor that should influence the choice of evaluation methodology includes the type of suppliers that a company has. In the supplier performance management program, it is important for company personnel to focus on the higher value and more strategic suppliers since these suppliers contribute the greatest amount of risks. It often doesn't make economic sense to include low dollar value, one time business, or non-strategic suppliers in this type of program. By grouping these top suppliers together and examining the company's relationships with them, some common attributes will become evident. These attributes of the relationship can be used to develop the areas and metrics with which to measure. 3. **Working with Suppliers for the Best Outcomes** It is also important to work with the suppliers when developing these metrics and areas of focus. Some of the companies that are best at examining supplier performance continually interact with their suppliers, communicate with them frequently, and use a mutually agreed upon system of metrics. This is a more collaborative approach with suppliers and ensures that supplier know what is expected of them. They can also make business plans and take steps to meet the goals and objectives that were set for them. The suppliers are also acutely aware of whether or not they have performed well or have performed poorly. 4. **Evaluating the Performance of the Supplier** Some methods that companies commonly use to evaluate and measure supplier performance include: a. *Site visits f. Requiring external certifications k. Independent ratings* b. *Paper supplier questionnaires g. Developing own certifications* c. *Web based supplier questionnaires h. Third party reviews* d. *Organizing existing data i. Phone call with a supplier* e. *Internal questionnaires j. Contacts with other supplier customers* A. In order to be effective, the actual supplier evaluation must be structured in such a way that it produces information and data that can actually be used to make a decision. If the information the company receives from the completed supplier assessments is vague or ambiguous, then management cannot make any informed decisions based on this information and the effort was effectively wasted. B. When conducting supplier assessments based on internal feedback, it is important to include all people that had contact with a supplier or supplier products. This should not be limited to people who are likely to have incentives to give the supplier only a favorable review. C. The supplier evaluation should also be easy to fill out. If suppliers cannot understand the questions or the questionnaire/survey is long and difficult to fill out, they may not be as likely to return the assessment. D. Once there is a mechanism in place to periodically collect performance data from suppliers, the next step is to review the performance data. When evaluating supplier performance data, the two things to look for (besides the obvious) are large changes in the performance metrics and overall trends. By identifying trends, a company can make projections about where the performance data will be in the future and can take action accordingly. E. Once there is sudden drop in supplier performance or a downward trend, it is important to take action quickly. Quick action can reduce the risk of disaster, significant loss, and gives the company the ability to take steps to prevent bad outcomes. One of the first things to do is to contact the supplier and find out what went wrong and why. By communicating with the supplier, personnel can determine the cause of the problem and try to work with the supplier to make changes to bring the supplier performance back into compliance with the contract or with company policies. **Topic: KAIZEN** **Week: \# 13** **Learning Objectives:** **Upon completion of this module, you should be able to:** - Describe the different concepts of Kaizen and how it relates to the management - Communicate the proper cycles of Kaizen - Evaluate one's output **CONTENT** **[Topic \# 01: Kaizen Concepts]** **KAIZEN** is a Japanese word meaning **continuous improvement**. It is made up of two characters which are "kai", meaning "change," and "zen", which means "good". It is used to describe a company culture where everyone, from the CEO to the front desk clerk, regularly evaluates his work and thinks of ways to improve it. **HISTORY** - Kaizen originated in Japan as a result of World War II. Ironically, it involved in part from American business leaders like Dr. W. Edwards Deming who came to help restore the country. - It was first introduced by 1951 training film created by the American Economic and Scientific Section (ESS), although Dr. Deming is largely credited for instituting the principles of Kaizen in Japan. - Toyota has been known as the initial company that has started Kaizen. The application that Toyota used was called "Toyota Production System", where all line personnel are expected to discontinue their moving production line in the case of any irregularity, and suggestions for improvement are awarded as a reward. They succeeded eradicating all the wastes. **TRUTH ABOUT KAIZEN** A lot of people have misunderstood about Kaizen. People have the stereotype that Kaizen can make a dramatic change immediately and bring the profits right away. However, this is not true. Improvements under Kaizen are [small and incremental] but will bring huge results over time. **The process of Kaizen is based on common sense, low-cost and low risk approaches that guarantees gradual progress that pays off over time.** **2 TYPES OF KAIZEN** 1. **GEMBA (actual workplace)** is an action-oriented approach and refers to improvement activities that are carried out in the actual workplace like on the shop floor on the manufacturing line. It involves all aspect of daily work that can be improved. The heart of gemba kaizen lies in small changes that will transform the overall success of the company not right away but in the long run. 2. **TEIAN (plan)** represents a theory-based approach and refers to strategic improvements that are prejudiced by top management. The implementation of latest processes and practices play the most dominant role. The overall goals of teian kaizen are improved business and manufacturing practices. **3 IMPORTANT ELEMENTS OF KAIZEN** 1. **PUTTING QUALITY FIRSTT** Quality is typically among the most essential criteria that customer use to make the purchase. It relies mostly on the customer's point of view. Thus, quality refers to the customer's perceived characteristics and features that a particular product must possess. This also includes the quality of process that goes upon producing such product. **Kaizen recognizes that without a quality product, organizations will not be able to compete.** 2. **SPEAK WITH DATA** Kaizen is a problem-solving process. Since Kaizen deals with addressing problems or limitations, every situation must be correctly understood. In order to correct the problems in a process, detecting the problems is the first thing to do. Sound data must be gathered and evaluated for Kaizen to work for improvement. **Data is the lifeblood of kaizen.** 3. **THE NEXT PROCESS IS CUSTOMER** This means that all workers think that the next process are the customers. If all workers have to be cautious on what they are doing, the customers will get the high-quality product and service as a result. Kaizen views the whole work in a specific organization as a series of interrelated processes where each consists of a **supplier** and a **customer.** - The supplier provides the process with inputs such as materials and/or information - The customer is either someone in the organization (internal customer) or the final customer out in the market (external customer). The customer receives or deals with the output of the process. **[Topic \# 02: Kaizen and Management]** It is also essential that management is trained and be behind the effort. Kaizen will result in many more suggestions for improvements and changes and will take away from a strict focus on moving items quickly through the existing production process. **2 MAJOR COMPONENTS OF MANAGEMENT** 1. **MAINTENANCE FUNCTION** The objective of maintenance function is to maintain current technological, managerial, and operating standards. Under this function, the management must first establish policies, rules, directives and standard operating procedures (SOPs) and then work towards ensuring that everybody follows SOP. It can be achieved through a combination of discipline and human resource development measures. 2. **IMPROVEMENT FUNCTION** The improvement function is aimed at improving current standards. Under this function, management works constantly towards modifying the existing standards, once they have been mastered, and establishing higher ones. Improvement can be broken down between **innovation** and **Kaizen**. - **Innovation** involves a drastic improvement in the existing process and requires large investments and big efforts. - **Kaizen** signifies small improvements as a result of coordinated continuous efforts by all employees. **ROLES OF A MANAGER IN TOTAL QUALITY MANAGEMENT (TQM) IMPLEMENTATION** 1. **Act as a facilitator at the workplace-** It is the duty of a manager to assist employees in implementing TQM. It is also his responsibility to choose and assign right individuals who can work as line managers and take charge of the whole project. Furthermore, he is responsible to allocate resources for TQM, schedule time for different training programs and be grateful for employees who come up with a variety of improvement ideas and strategies which would aid the organization bring better quality products. 2. **Communicate the benefits of total quality management to all other member of the organization-** The manager must call all employees on a common platform and address the benefits and importance of TQM. Make them understand that a successful TQM program implementation would give way to high quality products which would benefit the organization and the employee as well. **[Topic \# 03: Plan-Do-Check-Act Cycle]** **PDCA** (plan--do--check--act or plan--do--check--adjust) is a four-step management method used in business to control and continuously improve processes and products. It is also known as the Deming circle/cycle/wheel, Shewhart cycle, control circle/cycle, or plan--do--study--act (PDSA). **The Four Steps** 1. 2. 3. 4. **[Topic \# 04: Standard-Do-Check-Action Cycle]** SDCA (standard-do-check-action) cycle ensures that the improvements that have been done using Kaizen works well and it will not slide back. Improvement without standardization is stillborn to say the least. **The Four Steps** 1. *Standard:* Standards are created with the employees (Data users are involved). Standards should be: a. simple, clear and conspicuous d. measured according to the delegation of tasks b. the best, easiest, and safest ways one at a time e. quality-assured and cost-effective c. guideline oriented to enable quality performance 2. *Do:* Carrying out the standard (training, practice, experience). 3. *Check:* Compare standard with current situation to verify intended use. 4. *Action:* Modify the standards based upon the results from checking the standard. **Topic: measurEment guides of quality control (Process Capability Studies and Measurement System Analysis)** **Week: \# 14-15** **Learning Objectives:** **Upon completion of this module, you should be able to:** - Understand the process capability estimates and the purpose and fundamentals of measurement system analysis. - Apply practical concerns when conducting capability studies. - Communicate the characteristics and general requirements of measurement systems. - Evaluate one's learning.  **CONTENT:** **[Topic \#1: Process Capability Estimates]** **Process capability** is defined as a statistical measure of the inherent process variability of a given characteristic. You can use a process-capability study to assess the ability of a process to meet specifications. During a quality improvement initiative, such as [Six Sigma](https://asq.org/quality-resources/six-sigma), a capability estimate is typically obtained at the start and end of the study to reflect the level of improvement that occurred. **Several capability estimates are in widespread use, including:** - **Potential capability (C~p~) and actual capability during production (C~pk~)** are process capability estimates. C~p~ and C~pk~ that show how capable a process is of meeting its specification limits, used with continuous data. They are valuable tools for evaluating initial and ongoing capability of parts and processes. - **\"Sigma\" **is a capability estimate typically used with [attribute data](https://asq.org/quality-resources/attribute-variable-tutorial) (i.e., with defect rates) - **Assessing process capability** Assessing process capability is not easy. Some textbooks teach users to wait until the process reaches equilibrium, take roughly 30 samples and calculate their standard deviation; however, it is difficult to know when the process reaches a state of equilibrium and if the recommended samples are representative of the process. The measurement of process capability is more complicated than that. For example, suppose you have a rotary tablet press that produces 30 tablets, one from each of 30 pockets per rotation. If you're interested in tablet thickness, you might want to base your estimate of process capability on the standard deviation calculated from 30 consecutive tablets. Better yet, you might assure representation by taking those 30 consecutive tablets repeatedly over eight time periods spaced evenly throughout a production run (Table 1). You would pool the eight individual standard deviations yielding a thickness capability estimate based on (8 X (30 - 1)) = 232 degrees of freedom. Period -------- -------- --- ----- --- sample 1 2... 8 1 X X... x 2 x x... X... 30 x x... X **Table 1: Assessing Process Capability: Sampling Scheme Example** For greater assurance yet, you might want to include several production runs with perhaps fewer sampling times per production run. Estimates of the process capability made this way would be representative and independent of process mean changes that might take place from one sampling time to the next. Because the pooled, within-group standard deviation is calculated on observations taken close together in time, there is no opportunity for it to be contaminated by assignable sources of variation. It is as close to pure capability as you're likely to get.  **[Topic \#2: Practical Concerns when Conducting Capability Studies]** There are **both positive and negative aspects** to capability estimates. For example, C~p~ and C~pk~ estimates are highly sensitive to the assumption that one is sampling from a [normal distribution](https://asq.org/quality-resources/histogram)---that is, most of the data points are concentrated around the average (mean), forming a bell--shaped curve. Furthermore, [sampling](https://asq.org/quality-resources/sampling) from a stable system is essential to obtaining meaningful estimates of process performance for future production. Many quality practitioners report solely the numerical values of the capability estimates. Others, however, note that the capability estimates are themselves merely [statistics](https://asq.org/quality-resources/statistics), or point estimates of the true capability of a process. As such, the use of confidence intervals for the true capability values may also be reported. When sampling from stable, but non-normal distributions, other strategies to obtain meaningful capability estimates may be appropriate, including: - Transforming the data to be approximately well modeled by a Normal distribution. - Using an alternate - Probability distribution, such as Weibull or lognormal distributions. **[Topic \#3: Purpose, Fundamentals, and Characteristics of Measurement System Analysis]** - Measurement System Analysis (MSA) ================================= [Purpose] --------------------- If measurements are used to guide decisions, then it follows logically that the more error there is in the measurements, the more error there will be in the decisions based on those measurements. **The purpose of Measurement System Analysis is to qualify a measurement system for use by quantifying its accuracy, precision, and stability.** An example from industry serves to illustrate the importance of measurement system quality: A manufacturer of building products was struggling to improve process yields, which had a significant impact on product cost. Experience indicated that there were several process and environmental characteristics that influenced the process yield. Data were collected on each of the variables believed to be significant, followed by regression and correlation analysis to quantify the relationships in statistical terms. The results showed no clear correlation between anything - in spite of years of anecdotal evidence to the contrary! In fact, the underlying strong correlation between variables was confounded by excessive error in the measurement system. When the measurement systems were analyzed, many were found to exhibit error variation 2-3 times wider than the actual process spread. Measurements that were being used to control processes were often leading to adjustments that actually increased variation! People were doing their best, making things worse. As you can see from this example, Measurement System Analysis is a critical first step that should precede any data-based decision making, including Statistical Process Control, Correlation and Regression Analysis, and Design of Experiments. The following discussion provides a broad overview of Measurement System Analysis, along with a [spreadsheet analytical tool that can be downloaded (Gage R&R Worksheet) ](https://www.moresteam.com/toolbox/download/randr.xls). [Characterization] ------------------------------ A measurement system can be characterized, or described, in five ways: ### [Location (Average Measurement Value vs. Actual Value):] 1. **Stability** refers to the capacity of a measurement system to produce the same values over time when measuring the same sample. As with statistical process control charts, stability means the absence of \"Special Cause Variation\", leaving only \"Common Cause Variation\" (random variation). 2. **Bias**, also referred to as Accuracy, is a measure of the distance between the average value of the measurements and the \"True\" or \"Actual\" value of the sample or part. See the illustration **(Figure 1)** below for further explanation. 3. **Linearity** is a measure of the consistency of Bias over the range of the measurement device. For example, if a bathroom scale is under by 1.0 pound when measuring a 150 pound person, but is off by 5.0 pounds when measuring a 200 pound person, the scale Bias is non-linear in the sense that the degree of Bias changes over the range of use. ### [Variation (Spread of Measurement Values - Precision):] 4. **Repeatability** assesses whether the same appraiser can measure the same part/sample multiple times with the same measurement device and get the same value. 5. **Reproducibility** assesses whether different appraisers can measure the same part/sample with the same measurement device and get the same value. **The diagram below illustrates the difference between the terms \"Accuracy\" and \"Precision\":** Efforts to improve measurement system quality are aimed at improving both accuracy and precision [Requirements] -------------------------- The following are general requirements of all capable measurement systems: - Statistical stability over time. - Variability small compared to the process variability. - Variability small compared to the specification limits (tolerance). - The resolution or discrimination of the measurement device must be small relative to the smaller of either the specification tolerance or the process spread (variation). As a rule of thumb, the measurement system should have resolution of at least 1/10th the smaller of either the specification tolerance or the process spread. If the resolution is not fine enough, process variability will not be recognized by the measurement system, thus blunting its effectiveness. [Measurement Systems Analysis Fundamentals] ------------------------------------------------------- 1. Determine the number of appraisers, number of sample parts, and the number of repeat readings. Larger numbers of parts and repeat readings give results with a higher confidence level, but the numbers should be balanced against the time, cost, and disruption involved. 2. **Use appraisers** who normally perform the measurement and who are familiar with the equipment and procedures. 3. Make sure there is a set, documented measurement procedure that is followed by all appraisers. 4. **Select the sample parts to represent the entire process spread.** This is a critical point. If the process spread is not fully represented, the degree of measurement error may be overstated. 5. If applicable, mark the exact measurement location on each part to minimize the impact of within-part variation (e.g. out-of-round). 6. Ensure that the measurement device has adequate discrimination/resolution, as discussed in the **Requirements **section. 7. Parts should be numbered, and the measurements should be taken in random order so that the appraisers do not know the number assigned to each part or any previous measurement value for that part. **A third party should record the measurements, the appraiser, the trial number, and the number for each part on a table.** [Stability Assessment] ---------------------------------- 1. Select a part from the middle of the process spread and determine its reference value relative to a traceable standard. If a traceable standard is not available, measure the part ten times in a controlled environment and average the values to determine the **Reference Value. **This part/sample will be designated as the **Master Sample.** 2. Over at least twenty periods (days/weeks), measure the master sample 3 to 5 times. Keep the number of repeats fixed. Take readings throughout the period to capture the natural environmental variation. 3. Plot the data on an x̄ & R chart - consult the Statistical Process Control section of the Toolbox and calculate control limits. 4. Evaluate the control chart for statistical control. Again, consult the Statistical Process Control section of the Toolbox for assistance with this assessment. [Bias Assessment] ----------------------------- 1. Subtract the reference value from x̄ to yield the Bias: 2. Calculate the Bias percentage: **Bias Percentage = Bias / Process Variation** 3. **Analyze the results**. If there is a relatively high value, examine the following potential root causes: - Appraisers not following the measurement procedure - An error in measuring the Reference Value - Instability in the measurement. If the SPC chart shows a trend, the measurement device could be wearing or calibration could be drifting. - [Repeatability and Reproducibility Assessment (Gage R&R):] ---------------------------------------------------------------------- This discussion refers to the data collection sheet sample that follows as Figure 2. **You can download the data collection and analysis spreadsheet at the end of this section. Follow the steps below to conduct a Gage R&R study:** 1. Determine the number of appraisers, trials, and parts, which may vary from study to study. A rule of thumb is 2-3 appraisers, 2-3 trials, and 5-10 parts - with 10 being greatly preferred. In this example we will use 2 appraisers, 3 trials, and 10 parts. 2. Identify three appraisers who are all trained in the proper measurement procedure and identify them as A, B & C. 3. Fill in the yellow blanks at the top of the form with the required background information (Gage Type, Date, etc.). Also fill in the blank at the bottom of the form asking for the total specification tolerance. 4. Collect ten parts that represents the range of process variation. If the parts don\'t vary as much as the process, the gage error will be overstated. 5. Identify each part with a number 1-10 in such a way that the appraisers cannot see the numbers as they take the measurements. 6. Please refer to the data collection chart below. You will see that appraiser A\'s three trials are recorded in rows A-1, A-2, and A-3. Likewise, Appraiser B has rows B-1, B-2, and B-3, and Appraiser C has rows C-1, C-2, and C-3. 7. Start with Appraiser A and measure each of the ten parts in random order. A third party should record the results of the first trial in row A-1. Proceed to Appraisers B & C following the same process. Then repeat the process for trials two and three. The analysis of measurement error is output in the green-shaded boxes on page 2 of the spreadsheet, which is shown below:  - Variation from the measurement device, or Repeatability, equals 25.98% of the total part variation, and 28% of the specification tolerance. - Variation from the appraisers, or Reproducibility, is equal to 6.02% of the total part variation, and 7% of the specification tolerance. - Total variation from Repeatability and Reproducibility combined (they are not directly additive) is 26.67% of the total variation, and 29% of the specification tolerance. **TAKE NOTE!** **The rule of thumb for acceptance of a measurement system is a total Gage R&R of 30% or less of the lesser of Total Variation or the Specification Tolerance.** In this case, the measurement system is capable, and can be used as a basis of decision making. If the measurement system has error in excess of 30%, the first step to improve results is to analyze the breakdown of the error source. If the largest contributor to error is Repeatability, then the equipment must be improved. Likewise, if Reproducibility is the largest source of error, appraiser training and adherence to procedures can yield improvement. **Topic: PROCESS INVOLVEMENT METHODOLOGIES** **Week: \# 16** **Learning Objectives:** **Upon completion of this module, you should be able to:** - Compare and Contrast between internal from external customer - Communicate customer satisfaction and its nature - Understand customer focus and customer service - Evaluate one's learning and output **CONTENT** **Which Process Improvement Methodology Should You Use?** **PROCESS IMPROVEMENT METHODOLOGIES** - **[Six Sigma](https://www.lucidchart.com/blog/process-improvement-methodologies#sixsigma): A data-driven approach to reduce defects to improve an organization\'s performance.** - **[Lean manufacturing](https://www.lucidchart.com/blog/process-improvement-methodologies#lean): A systematic process to minimize waste without sacrificing productivity.** - **[Lean Six Sigma](https://www.lucidchart.com/blog/process-improvement-methodologies#leansixsigma): A combination of Lean and Six Sigma methodologies.** - **[Total Quality Management (TQM)](https://www.lucidchart.com/blog/process-improvement-methodologies#tqm): An organization-wide effort focused on continuous improvement to improve customer quality.** - **[Toyota System Production/Just-in-time](https://www.lucidchart.com/blog/process-improvement-methodologies#tps): Methodology center2ed around reducing inventory costs, manufacturing products only as they\'re needed.** - **[Theory of Constraints](https://www.lucidchart.com/blog/process-improvement-methodologies#toc): A systematic process focused on finding and eliminating constraints.** Process engineers evaluate and develop processes to increase productivity and scale their businesses. To fulfil this role, you need a process for evaluating and improving processes. You don't have to reinvent the wheel to find a methodology that works for process improvement, but you might not be sure which methodology to use when professionals throw around terms like DMAIC and TQM. Learn more about the top approaches to process improvement below and the diagrams that can assist you through every step. **SIX SIGMA** [Six Sigma](https://www.lucidchart.com/blog/what-is-six-sigma-project-management-methodology) began at Motorola, became a core part of the strategy at General Electric, and has since been used widely for manufacturing and business processes. This method helps companies measure defects or inconsistencies in a process to deliver perfect products and services. Within Six Sigma, process engineers use two sub-methodologies, DMAIC for improving existing processes and DMADV for creating new processes. The more widely used of the two, DMAIC follows these steps: - **Define** the opportunity for improvement (project goal). - **Measure** the performance of your existing process. - **Analyze** the process to find any defects and their root causes. - **Improve** the process by addressing the root causes you found. - **Control** the improved process and future process performance to correct any deviations before they result in defects. DMADV follows similar steps, though users will look at different factors since a process does not exist yet: - **Define **the process goal, keeping in line with the overall company strategy and customer needs. - **Measure** the factors that are critical to quality (called CTQs). - **Analyze** various design and development options. - **Design** the process. - **Verify** that the design meets process goals and customer needs. Pilot the process and, if successful, implement the process. Six Sigma relies on data and statistics to make decisions more than other methodologies. By using DMAIC and DMADV, Six Sigma organizations should see clear financial returns and strive for less than 3.4 defective features in every million opportunities, or chances for a defect. **LEAN MANUFACTURING** As the name would suggest, the Lean methodology strives to cut costs by eliminating waste. Although it is often referred to as Lean manufacturing, Lean's core ideas can apply to every organization and process. (See our complete breakdown of [Lean vs. Six Sigma](https://www.lucidchart.com/blog/lean-vs-six-sigma).) Someone using this method would evaluate a process's value stream. The value stream consists of value-added activities (the actions a customer would pay for) or non-value-added activities in the process that either brings a concept to fruition or completes an order. Any action that doesn't add value or isn't required as part of a policy or regulation is waste. Waste can include: - **Transportation:** the movement of products unnecessary for the process - **Inventory:** materials that aren't required to process current orders - **Motion:** people or equipment that move more than necessary to complete the process - **Waiting:** periods of inactivity or interruptions in production - **Overproduction:** excessive production of materials ahead of demand - **Overprocessing:** extra work due to redundancies or poor tool/product design - **Defects:** the effort involved in checking for and fixing defects in the system - **Skills:** the act of underutilizing the knowledge and skills employees have Process engineers identify these areas of waste to increase overall value to customers. **LEAN SIX SIGMA** Just as the name suggests, Lean Six Sigma is a combination of the previous two methodologies. Taking a Lean approach to Six Sigma helps you eliminate waste from your organization and reduce process defects. Lean Six Sigma helps you save time, improve quality, and cut costs. It relies on DMAIC and combines the tools from both methodologies, such as value stream maps and SIPOC analysis diagrams. **TOTAL QUALITY MANAGEMENT (TQM)** Total Quality Management predates Six Sigma and Lean methodologies, gaining a lot of attention in the late 1980s when the US Federal Government began using it. Success results from customer satisfaction within this system. As with Six Sigma, TQM can vary from company to company, but organizations using TQM generally follow these principles: - Organizations should follow a strategic and systematic approach to achieve their goals. - Customers determine the level of quality. - All employees work toward common goals. Effective communication and training ensure that everyone understands the definition of quality and strives to achieve it. - Organizations should define the required steps of any process and monitor performance to detect any deviations. They should continually look for ways to be more effective and more competitive. Measurements for quality depend on the company, though some use established standards, such as the ISO 9000 series. **TOYOTA PRODUCTION SYSTEM/JUST-IN-TIME** Also known as just-in-time, the Toyota Production System (TPS) was developed by Taiichi Ohno in Japan, after World War II, to save time during production and reduce inventory cost. Using the [Kaizen approach](https://www.lucidchart.com/blog/kaizen-methodology) of small positive improvements, the basic tenant of TPS is to only produce products when needed, avoiding large inventory stocks.  TPS is typically used by process engineers in tandem with [Kanban project management](https://www.lucidchart.com/blog/how-kanban-methodology-can-improve-your-team) to easily see and track current processes while preventing hidden problems. There are 4 main principles of TPS:  **1. Philosophy** Use your organization\'s long-term philosophy to guide decisions rather than short-term financial goals. **2. Process** Find the right process to produce the right results. This principle may involve:  - Using an ongoing process flow to find problems quickly - Implementing the \"pull\" system to prevent overproduction  - Employing visual controls to see the entire process to avoid hidden problems  - Using only reliable technology necessary for your people and processes  **3. People and partners ** Invest in the people to create leaders that embody that company\'s philosophy and can teach it to others. **4. Problem-solving** In-still a culture of learning for continuous improvement. Fully understand the problem before determining a solution, and avoid rash decisions. Instead, take time to reach a consensus.  **THEORY OF CONSTRAINTS ** First introduced in the early 1980s by Dr. Eliyahu Goldratt, Theory of Constraints (TOC) identifies the biggest factor and prevents a goal from being achieved and then uses a systematic process to improve the constraint until it is no longer a limitation.  According to TOC, organizations will always face at least one constraint, meaning that there will always be something to be improved. To use TOC, to remove constraint, use these five repeatable steps:  1. Identify the constraint.  4. Alleviate the constraint.  2. Decide how to exploit the constraint.  5. Repeat the process as needed.  3. Subordinate and synchronize to the constraint.  We've covered six major process improvement methodologies, but there are many more available, along with a ton of additional practices that correspond with Six Sigma, Lean, and TQM. Dive deeper into any of these methodologies with the resources above.  Define, analyze, and optimize your path to process improvement. Total quality management ensures that employees understand their target customers well before making any changes in the processes and systems to deliver superior quality products for better customer satisfaction. In fact, organizations introduce total quality management or any other quality management process to increase their customer base and levels of customer satisfaction. Total quality management increases an organization\'s database of loyal customers who would not go anywhere, no matter what. Without customers, a business cannot even exist. **IDENTIFYING CUSTOMERS** There are two distinct types of customers namely external and internal. ***Internal customers*** are within the company. They are the colleagues working together for delivering a service or product for the external customer. Every function, whether it is engineering, order processing, or production, has an internal customer. Each internal customer receives a product or service, in exchange, provides a product or service. Every person in a process is considered a customer of the preceding operation. An internal customer can be anyone within an organization. It could be another department, another branch or even a co-worker. Getting the internal relationships working is essential it external customers are to be satisfied. Every single person in the organization has an effect on the external customers ***An external customer*** may be an individual or an enterprise that in exchange that hires or purchases the product(s) or service(s) from another person or business in exchange of money. An external customer is someone who exists outside the organization. An external customer can be defined in many ways, such as 1\. The one who use the product or service. 2\. The one who purchases the product or service. 3\. The one who influences the sale of the product or service. One of the most important factors for the success of an enterprise is its customers. Without them, a business cannot exist. In order to capture customers, a business must try to find out what people want, how much, how often they will buy, and how their post-purchase satisfaction will be ensured. **CUSTOMER SATISFACTION** Customer satisfaction is not an objectively measured but more of a feeling or attitude. It enhances customer loyalty, which is the feeling of attachment to or affection for a company\'s people, product or services. If a customer is pleased with a product or a service he has hired or purchased he will pay his bills promptly, which greatly improves cash flow-the lifeblood of any organization. Customers that are pleased will increase in number, buy more, and buy more often. Through delighting the customer satisfied customers can be turned into loyal customers. Loyalty generates constant purchases and increased revenues, therefore leading to organizational excellence. Employee satisfaction is needed to maintain continuous improvement and external customer satisfaction. Delighted employees who feel proud of their work have an outstanding performance, thus having a positive impact on business excellence. [The customer will always be the judge of quality.] Understanding customer needs, both current and future and keeping pace with changing market require effective strategies for listening to and learning from customers, measuring the satisfaction relative to competitors and building relationships. Customer satisfaction leads to repeat purchases at purchases lead to loyal customers. In turn, customer\'s loyalty leads to enhanced brand equity and higher profits. Within organizations, customer satisfaction ratings can have powerful effects. They focus employees on the importance of fulfilling customers\' expectations. Furthermore, when these ratings dip, they warn of problems that can affect sales and profitability. When a brand has loyal customers, it gains positive word-of- mouth marketing, which is both free and highly effective. Therefore, it is essential for businesses to effectively manage customer satisfaction. Firms need reliable and representative measures of satisfaction to do this. In researching satisfaction, firms generally ask customers whether their product or service has met or exceeded expectations. Thus, expectations are a key factor behind satisfaction. When customers have high expectations and the reality falls short, they will be disappointed and will likely rate their experience as less than satisfying Customer delight arises when perceptions exceed expectations. External Customer satisfaction shows the extent to which the organization: 1. Uses methods for determining and monitoring external customers perceived quality and value. 2. Uses customer feedback to improve product/service quality 3. Handles complaints, resolves them, and uses complaint information for on for quality improvement and prevention of recurrence of problems 4. Measures performance against customer targets. 5. Compares its customer satisfaction results with that ot main competitors **A Summary of ways to improve internal customer satisfaction is given below:** - Treat employees as the company would treat its customers- They are valuable members of the organization and they must feel important for the organization. - Share the company vision - Communicating the company\'s vision with the employees will make them feel a part of the company. It can help them align their goals with those of the company. - Surpass their expectations- To make employees happy, offer unexpected gifts or bonuses, arrange team parties, take them out for a team lunch or dinner, and other ways. - Take feedback and suggestions-To better understand employees; the company must know what they feel about their jobs, or their work environment. - Show appreciation for good work - Appreciate a good work done. **How would you satisfy your customer?** Here are some of the methods that could be used to satisfy customers: **Here are some approaches to customer satisfaction:** 1. Regular customer feedback system - This involves allowing communication from customers through emails, suggestion boxes. One should keep all documents and send copies to the person who made the complaint. 2. Market research- This is done to understand customers better. This can be done through sampling a few customers using appropriate sampling techniques and a detailed study is conducted on their likes and dislikes. 3. New or last customer survey- These are useful ways of finding out what attracts customers to the organization and indeed why they left. 4. Focus groups - This is intended to know what customers are thinking. A group of customers is assembled in a meeting to answer a series of questions. 5. Customer visits - This involves making visits to the customer\'s premises to collect information. These are meant to know how the product or service is performing 6. Front line personnel - This is the use of employees who are in direct contact with customers to understand the customers' expectations. These employees should be trained on how to carry out this task. 7. Critical incidents technique -- This attempts to identify issues that delight the customer and those that satisfy them. **Determinants of Customer Satisfaction** There are two key indicators of customer satisfaction, namely: **1. Key Indicators for Physical Products** a\. Reliability c. Adaptability e. Functionality b\. Aesthetics d. Usability f. Appropriateness **2. Key Indicators for Services** a\. Friendliness/courteousness of employees e. Appearance of physical facilities b\. Safety/risk of service f. Approachability of the service provider c\. Billing/invoicing procedure g. Willingness to listen to customer d\. Responsiveness to requests h. Honesty and an ability to communicate in clear language **CUSTOMER FOCUS** Whatever companies do for quality improvement, it must always be remembered that only customers determine the level of quality. Whatever they do to foster quality improvement such as training employees and integrating quality into processes management, only customers determine whether their efforts are worthwhile. The customers are the valuable assets for any organization. The success of an organization depends on the satisfied customer. The satisfied customer tends to purchase frequently and more. Focusing on the customer involves designing products or services that meet or exceed the customer\'s expectations. This involves the product itself, its functionality, attributes, convenience and even the means by which the information about a product is received by a client. The Human Resource department is interested in making sure employees are qualified to perform their jobs. By having qualified and trained employees on team, the organization will run effectively. Encouraging mutual respect and teamwork is important because it fosters single-organizational culture of excellence by showing that every employee from top to bottom of the hierarchy hold the same Quality Control principles at heart. **CUSTOMER SERVICE** Quality assurance means developing operational controls to ensure that the results match the desired outcomes. Customer service operations are designed to keep customers satisfied while protecting the organization. To make sure customer service achieves these goals in business, the person responsible for quality assurance must define the quality functions as they apply to how the company serves its customers. Once such definitions are in place, it can define the resources required to fulfil the defined mandate and make sure customers experience quality service. **Customer Service Quality Goals** Customer service means helping customers solve problems. To carry out this function effectively, customer service has to be easily accessible, knowledgeable, reliable and deliver results. Quality assurance identifies these requirements and measures how well customer service performs with respect to each one. The characteristics that make customer service effective. - **Reliability** The quality assurance system can compare what the company promise the customer to what the customer expects and what the customer service delivers. If the delivered service matches customer expectations and what is promised to deliver, quality with respect to this customer service element is high. For use as gauge of reliability, the survey must specifically ask how well the company service met the customer\'s expectations. - **Competence** Customers expect competent delivery of their services, and the definition of quality assurance includes tracking competence. Quality assurance systems evaluate competence by training and results. The quality assurance system keeps records of training and surveys customers to evaluate the competence of the delivery. It assigns scores for completed training and for the degree of competence in service delivery compared to benchmarks based on industry standards. A low score means employees have less training or apply their training less competently than the rest of the industry. The company can address such a problem through additional training. - **Delivery** Customers expect reliable and competent service delivery in an easily accessible form. Customer service delivery is typically over the phone or other means of electronic communication. Wait times, busy signals, noise, call quality and call cost reduce the quality of delivery. The definition of quality assurance includes tracking these parameters, defining reasonable levels and ensuring that those levels are maintained over time. - **Solutions** Customers are mainly interested in solutions to their problems. Quality assurance includes documenting customer complaints, tracking the actions taken to resolve them and surveying customer on their satisfaction with the result. **Topic: QUALITY MANAGEMENT SYSTEM** **Week: \# 17** **Learning Objectives:** **Upon completion of this module, you should be able to:** - Apply International Organization for Standardization in their future business/career. - Demonstrate the process of ISO certification. - Communicate the concept of Performance Dashboard - Evaluate one's learning and output **CONTENT** **IS0 STANDARDS** The International Organization for Standardization (ISO) is an international standard-setting body composed of representatives from various national standards organizations. Founded on 23 February 1947, the organization promotes worldwide proprietary, industrial and commercial standards. ISO International Standards ensure that products and services are safe, reliable and of good quality. For business, they are strategic tools that reduce costs by minimizing waste and errors, and increasing productivity. They help companies to access new markets, level the playing field for developing countries and facilitate free and fair global trade. **History of ISO** In London, in 1946, 65 delegates from 25 countries meet to discuss the future of International Standardization. In 1947, ISO officially comes into existence with 67 technical committees (groups of experts focusing on a specific subject). In 1949, ISO moves into offices in a small, private house in Geneva. In the early 1950s the Central Secretariat has 5 members of staff. In 1951, the first ISO standard (called Recommendations at this time), ISO/R 1:1951 Standard reference temperature for industrial length measurements, is published. Since then, the standard has been updated numerous times and is now ISO 1:2002 Geometrical Product Specifications (GPS) - Standard reference temperature for geometrical product specification. In 2005, ISO and IECs joint technical committee JTCI launches ISO/IEC 27001, a management system standard on information security. As businesses become increasingly reliant on information technology, Securing the system and minimizing risks is ever more important, I0 27001:2005 has become one of ISO\'s most popular standards In 2008, ISO, TTU and ITC are congratulated with an Emmy Award for their work in producing an advanced video coding standard. In 2009, 1SO\'s current Secretary General Rob Steele is appointed. ISO takes on a new mission to be simpler, faster, better to cut down standards development time and to better serve the needs of today\'s society. In 2010, ISO 26000, the International Standard providing guidelines for social responsibility, is launched. The working group that developed ISO 26000 is one of the largest and most diverse groups to develop an ISO standard. The resulting document is truly multi-stakeholder At the start of 2012, ISO has 163 members and has a total of over 19,000 standards. Today, ISO International Standards cover almost all aspects of technology and business. **Different Types of ISO** The International Organization for Standardization (1SO) is a non-governmental network of national agencies whose purpose is the development of international standards for business and government. International standards are designed for trade between countries. They provide a technological base and a system of best management practices. Standards ensure safe products and organizational procedures that reduce environmental impact. Standards benefit trade and business by simplifying procedures and reducing an organization\'s environmental risk. Consumers benefit by the knowledge that state-of-the-art practices are developed for global relevancy **Quality Management** The ISO 9000 family addresses various aspects of quality management and contains some of ISO\'s best known standards. The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customers' requirements, and that quality is consistently improved. **Standards in the ISO 9000 family include:** ISO. 9001:2015 - sets out the requirements of a quality management system ISO. 9000:2015 - covers the basic concepts and language ISO 9000:2009 - focuses on how to make a quality management system efficient and effective ISO 19011:2011 sets out guidance on internal and external audits of quality management systems. ISO. 9001:2015- This ISO sets out the criteria for a quality management system and the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 70 countries certified to ISO 9001. This standard is based on a number of quality management principles such as strong customer focus, the motivation and implication of top management. **Environmental Management** ISO 14001:2004. This ISO standard is the basis of development of an environmental management system (EMS). An EMS is a set of guidelines and procedures developed by an organization to ensure compliance. An EMS benefits an organization by increasing environmental awareness and investigating ways to reduce its costs. ISO 14004:2004. This ISO standard provides more specific information for implementation and maintenance of an EMS, with the aim to continually improve the plan based on its performance. The standard is applicable to any industry. IS0 5001. This yet-to-be-released standard will address energy management and ways to increase energy efficiency and reduce environmental impact of organizations. It will consider technical and topical issues, such as climate change and dependence on foreign oil. **Health and Safety** ISO 22000. This standard sets global guidelines for food safety and handling. Major corporations have embraced this standard, including Arla Foods and Krafts Foods. Its aim is to focus on the entire food chain and reduce hazards and safety issues such as food-borne illnesses. IWA 1:2005. This standard addresses issues in the healthcare sector. It provides guidelines for health care organizations to respond to natural and manmade disasters. Specifically, the standard gives recommendations for reducing error and organizational waste, while embracing a customer-centric framework. ISO 9001:2000. This standard addresses quality management in the medical device industry. It specifically provides suggestions and guidelines for industries involved in the development, production, and installation of these devices. The standard also considers continual monitoring within the industry. **Transportation** ISO/TS 16949. This standard reviews all areas of the automotive industry supply chain. It concentrates on areas of training, monitoring, analysis and improvements within the industry. The standard also focuses on ways for suppliers to reduce their costs and improve efficiency. ISO/PAS 30003:2008. This standard looks at specific concerns within shipping and marine technology. It focuses on areas, such as ship recycling management and other material handling, that can have potential environmental impacts. It addresses industry-specific concerns such as hazardous materials and asbestos emission. **Energy Management** ISO 50001. Using energy efficiently helps organizations save money as well as helping to conserve resources and tackle climate change. ISO 50001 supports organizations in all sectors to use energy more efficiently, through the development of an energy management system (EnMS). ISO 50001:2011. This is based on the management system model of continual improvement also used for other well-known standards such as ISO 9001 or ISO 14001. This makes it easier for organizations to integrate energy management into their overall efforts to improve quality and environmental management. ISO 50001:2011 provides a framework of requirements for organizations to: 1\. Develop a policy for more efficient use of energy 2\. Fix targets and objectives to meet the policy 3\. Use data to better understand and make decisions about energy use 4\. Measure the results 5\. Review how well the policy works, and 6\. Continually improve energy management. **Risk Management** ISO 31000. This standard is about the risks affecting organizations that can have consequences in terms of economic performance and professional reputation, as well as environmental, safety and societal outcomes. Therefore, managing risk effectively helps organizations to perform well in an environment full of uncertainty. ISO 31000:2009. This standard offers principles and guidelines, provides principles, framework and a process for managing risk. It can be used by any organization regardless of its size, activity or sector. Using ISO 31000 can help organizations increase the likelihood of achieving objectives, improve the identification of opportunities and threats and effectively allocate and use resources for risk treatment. However, ISO 31000 cannot be used for certification purposes, but does provide guidance for internal or external audit programmes. Organizations using can compare their risk management practices with an internationally recognized benchmark, providing sound principles for effective management and corporate governance. **Food Safety Management** ISO 2200. The ISO 2200 family of International Standards addresses food management. The consequences of unsafe food can be serious and ISO Safety management standards help organizations identify and control food safety hazards. As many of today\'s food products repeatedly cross-national boundaries. **Concept of Performance Dashboard** A performance dashboard sits at the intersection of two powerful disciplines: business intelligence and performance management. A performance dashboard is a layered information delivery system that parcels out information to users on demand so they can measure, monitor, and manage business processes and achieve strategic objectives. It is composed of the "three threes." There are three types of applications (monitoring, analysis, and management), three layers of data (graphical, dimensional, and transactional), and three types of dashboards (operational, tactical, and strategic.). The key to the success of any performance dashboard initiative is tight alignment between business and IT. The performance dashboard initiative must have strong sponsorship, engaged users, and managers who know how to use the dashboard metrics to drive change in a positive direction. Performance dashboards are common management tools used to gauge performance and enable business people to measure, monitor, and manage the key activities and processes needed to achieve business goals. They can be designed and developed to direct a wide range of objectives, from monitoring the usability of a global organization's business strategy to keeping a check on a department's ability to achieve targets. Performance dashboard provides three main sets of functionality: 1. Monitor critical business processes and activities using business performance metrics that alert users to potential problems. 2. Analyze the root cause of problems by digging into relevant and timely information. 3. Manage people and processes in order to improve decisions and optimize business performance. **REGISTRATION STEPS TO BECOME ISO CERTIFIED** After the company made the plans, built the quality system and conducted the audit, the next step is the ISO Registration Process. The purpose of registering the company is to show that it met the requirements. In order to do this effectively here are essential steps. 1. **Finding an 1SO 901 Registrar** There is a need to begin searching for an ISO registrar during the 2 to 3 months the company is still building its quality system. Search can be done in the ANSI-ASQ National Accreditation Board (ANAB) to select the registrar right for the company: Registrars must meet the requirements of the ISO Accreditation Bodies. These requirements include things such as independence. Registrars cannot consult for instance. This system ensures uniformity in the registration process. Accreditation Bodies maintain directories of the Registrar organizations that they accredit. These directories are available on their websites. 2. **Selecting an ISO Registrar** A company applying for registration should select a registrar that has experience within the scope category of its specific industry, which can be found also on the ANAB site. Accreditation, scheduling issues, fees and comfort level should be considered by the company when selecting for the right registrar. Registrar qualifications are a key consideration. There are registrars that have very limited in scope just based on their names. Registrars must be accredited in a particular industrial sector in order for them to be able to certify a company in that sector. Some registrars are accredited in several if not all sectors. 3. **Creating an ISO Application** A company and a registrar will agree on the application contract. This is an important step of the ISO Registration Process because it defines the rights and obligations of both parties, and includes liability issues, confidentiality and access rights. 4. **Conducting a Quality Document Review** The registrar will require a copy of the company quality manual and procedures to verify that all the requirements of the standard are addressed. The ISO Registration Process is not a quick process; the registrar should be allowed around 24 weeks in advance to fully review all of the necessary documents. 5. **Determining Pre-assessment Need** Though optional, this 2-4 week initial review of the system identifies any significant omissions or weaknesses. It saves time and allows the registrar to assess any issues and resolve logistics before the actual assessment audit. The Pre-assessment is an initial review of the company\'s Quality Management System to identify any significant omissions or weaknesses in the system and provide the organization an opportunity to correct any deficiencies before the regular registration assessment is conducted. During ISO 9001 Registration, only one pre-assessment may be conducted and Registrars cannot provide quality consulting or advice on system implementation. Evaluating the quality system and documentation to meet ISO requirements is allowed but registrars cannot provide guidance on how to implement a quality system. 6. **Issuing an ISO Assessment** During the audit, or physical onsite inspection of procedures in action, the auditors will issue findings if they assess anything that doesn\'t meet requirements, or nonconformities. The length of this step of the ISO Registration Process will depend on the scope of the audit and the size of the organization. In general, the flow of activities during the audit is as follows: 1. Opening Meeting - An introduction of the audit team and key personnel in the company. The scope and general approach to the audit is discussed. 2. Brief tour of the facility - Keep it brief, the auditors just want to get feel for the layout and processes involved. 3. Additional review of documents - Audit team members review documentation for areas they will audit. 4. Examination - The audit is conducted, personnel are interviewed, and evidence is collected to show the system has been effectively implemented, 5. Daily Review- At the end of each day or the beginning of the next, the audit team reviews any issues identified during the assessment. Potential findings or nonconformities may be clarified at this time. 6. Closing Meeting - The audit team states their conclusions regarding the audit and presents any findings or nonconformities that were identified along with any observations they may have. 7. Audit Report issued - Within a few weeks of the audit, the Registrar issues the audit report. The report generally restates what was discussed in the closing meeting. 7. **Completing ISO 9001 Registration** After all of the findings are put into the IS0 audit report and nonconformities are addressed, the registering company has the option to register as ISO 9001 conformant. The company will receive a certificate and can also be listed in a register, which the company can use to publicize its registration and use in advertising 8. **Checking with Surveillance Audits** To ensure that the system is maintained and that changes don\'t result in deficiencies in the system, registrars perform regular surveillances of the system. Over the three-year period of the certificate, auditors will perform one full and two partial checks of the company\'s system. **References:** **Week 10-11** **Week 12** https://www.epiqtech.com/supplier-performance-management.html **Week 13** TOTAL QUALITY MANAGEMENT- Prof Angelita Ong Camilar-Serrano, DBA, pp.87-95 **Week 14-15** https://www.moresteam.com/toolbox/measurement-system-analysis.cfm **Week 16** TOTAL QUALITY MANAGEMENT- Prof Angelita Ong Camilar-Serrano, DBA, pp.189-195 [https://smallbusiness.chron.com/customer-value-strategies 5099.html\#:\~:text=Customer%20value%20strategies%20present%20products,by%20working%20with%20your%20company.](https://smallbusiness.chron.com/customer-value-strategies%205099.html#:~:text=Customer%20value%20strategies%20present%20products,by%20working%20with%20your%20company.) **Week 17** TOTAL QUALITY MANAGEMENT- Prof Angelita Ong Camilar-Serrano, DBA, pp.220-231 https://onlinelibrary.wiley.com/doi/10.1002/9781119199984.ch1