Chapter 2 Quality Assurance PDF

CHAPTER 2: QUALITY ASSURANCE SYSTEM QUALITY CONTROL Quality control Control = a basic and important activity in food quality management. Without control, all other food quality management (FQM) functions, especially improvement and assurance, would have hardly any effect. Control re...

CHAPTER 2: QUALITY ASSURANCE SYSTEM QUALITY CONTROL Quality control Control = a basic and important activity in food quality management. Without control, all other food quality management (FQM) functions, especially improvement and assurance, would have hardly any effect. Control reduces variation.  less scrap and rework, fewer line stoppages, greater planning efficiencies, happier customers, repeat sales. OBJECTIVE: To produce a product that complies with targets within set tolerances. Quality control Once product has been designed & developed, the system must be controlled during manufacturing. The process of inspecting products to ensure that they are meet the required quality standards. Control = inspect + taking corrective actions when the performance is not in compliance with specifications  Quality control is described as the ongoing process of evaluating performance and taking corrective action when necessary (Evans & Lindsay, 1996). Involve both technological and management elements. Where qc is done? When raw materials are Whilst products are going When process are finished – received prior entering through the production takes place before product are production. (at the receipt) process. (during processing) dispatched to customers. (prior to distribution) 3 major points in food production Quality control basic activities Measuring or analysing product properties or process parameters to assess the actual product or process performance. Comparing the measured value or data against the standard with the specified tolerances. Evaluating the deviations to determine in which direction the product or process must be corrected and by how much. Taking corrective actions to bring the product or production process back “under control”. 4 Basic elements of quality control; Measure the process parameter Measuring Eg; Temperature Compared the measured value with the norm with specified tolerence Comparing Eg: temperature must be 25 ± 2 ℃ Determines the corrective action Evaluating Eg; the thermostat The actual action is carried out Corrective Eg: the heating system that is turned up action and down  Table 2.1 Examples of measuring activities specific to the quality control function. Type of Overall technological functions activities Supply (& storage) Production (i.e. Distribution (& transformation) storage) People Measuring storage Visual inspection of Measuring activities room temperature products after a temperature in Taking samples for particular processing distribution rooms analysis of hygienic step (e.g. meat parts Inspecting cleaning conditions after slaughtering, conditions in Inspecting incoming checking fecal spots distribution rooms products on on eviscerated Checking labels and irregularities poultry) packaging integrity Taking samples of Visual inspection of during storage incoming materials for products during Sampling and analysis of microbial processing (e.g. cheese analysis/ testing of contamination ripening process, final product quality brown colouring in Visual inspection of French fries end products (e.g. preparation) inspection of packaging and appearance of meals for catering  Table 2.1 Examples of measuring activities specific to the quality control function. Type of Overall technological functions activities Supply (& storage) Production (i.e. Distribution (& transformation) storage) Process Automated inspection Automated measuring Online measurement equipment of empty bottles for of process parameters of temperature during activities beer production like: transport Automated inspection  Pasteurization time of water supply and temperature in a milk production line  Oven temperature and conveyer belt speed in a baking line  Volume checking in a filling line  Packaging leakage sensors Incoming materials Production process (Intermediate) product Taking corrective action Measuring product properties and process parameters Evaluating the Comparing to Specifications (norm extent of standard and the and tolerances) deviation tolerances Figure 2.1: The basic activities of a control circle Variations in quality control 1) Raw materials 2) Methods and 3) People 4) Machines / measurements equipment used: Sampling (taking the Personnel hygiene Microbial right number of Shift work can form contamination due samples at the a great source of to improper cleaning appropriate variation location). Mistakes due to Sample preparation misunderstanding is crucial and results in variation. Quality control activities Three basic control process: Input, the supply control Transformation, the production control Output, the distribution control SUPPLY PRODUCTION DISTRIBUTION Incoming material Distribution control PRODUCT Product control control Service control CONTROL In storage control In storage control Complaint service Distribution Process control Supplier evaluation channel control RESOURCE Process capability Supplier Customer CONTROL analysis relationship relationships Equipment control Market analysis  Supply Control Receiving request: - the purchase department receives internal request, the description, design, quality & quantity, desired delivery dates Selecting suppliers: Identify a capable supplier, rating information. Quality Placing orders & monitoring delivery orders during transport : follow up make sure follow schedules, control appropriate quantity. Receiving supplies: check incoming activities shipments for quality & quantity, received in satisfactory condition, may need to be returned or replacement subjected to detailed inspection, shipment within the right temperature. Storing supplies: Goods must be kept in an appropriate storage conditions (temperature control, dry, dark etc). Supply control and its product- process and resource control cycles Typical factors a company could consider in supplier evaluation The most obvious factor, along with any discounts offered although Price often it is not the most important one. The quality reputation of the supplier? What quality assurance system Quality does the supplier have? Services Can replace any defective items? Fast response to complaints? Location Impact the shipping time, transportation cost and response time. Emergent cases Sometimes quality claims due to origin can play a role. When customer demands fluctuate (or seasonal), guarantees are Inventory policy of supplier needed about on-time deliveries. The ability of supplier to respond to changes in demands and to accept Flexibility design changes can be important considerations.  Production Control How much to inspect, how often, & at what points in the process inspection should occur Look for safety risk in food production, Quality process conditions are controlled intensively, e.g intensive cleaning & control disinfection. Check the raw materials and finished activities products, take corrective action if necessary. Equipment evaluation: cleaning, maintenance, redesign & modification to improve reliability and in food industry, hygiene.  Steps in the product control process Planning production Planning Considering about the production equipment (availability, quality performance, costs) and the customer orders into a production schedule. Time pressure makes it impossible to meet quality standards. Placing order Placing production order The production schedule is sent to the production/ manufacturing department. Quality requirements Informing on quality requirements A detailed specification of customer requirements and/or specific company and legal requirements connected to the customer orders. Transporting materials Transporting Internal transport of raw materials, ingredients, packaging materials, process aids, etc. needed for the food production process. Producing the customer order Producing order A sequence of technological process activities up to packaging and transporting to the storage facilities. Storing Storing the products Stored until batch has been inspected and can be released. Production control and its product- process and resource control cycles  Distribution Control Managing the flow from manufacturers to customers, including the storage and transportation of products. 1) selling, receiving orders: Delivery time, price, quality specifications, annual contracts Quality 2) transportation and storage: Temperature, humidity conditions, hygenic conditions need to be control monitored along the process. 3) Buying & consumer usage: Describe activities the retailers (storage). Consumer usage is restricted to information on package, leaflets/magazine. 4) Complaints, market information & analysis: use this information for quality improvement. Short time basis; when consumer problems need to be solved immediately. Long term; information for product re-design. Quality Assurance Quality assurance is an activity or set of activities performed to ensure that the food quality and food safety requirements of a food are fulfilled. An approach that tries to ensure quality is built in to a product or service https://youtu.be/QDn6TnOM46s?feature=shared Another definition for Quality assurance: The process that ENSURE production quality meets the requirements of customers QA:Prevent defects in products & services QC: Detect defects & correcting them  To assure the requirements are achieved, with its incoming materials (raw material/input), technological process (i.e transformation/processing) and final Aims of QA products (Output) - The ability to determine critical points in products, processes and the production environments.  To guarantee that quality requirements, such as product safety, quality, integrity and service are fulfilled by the quality management systems. ISO9001 defines a quality management Aims of QA system (QMS) as a set of interrelated or interacting elements that organisations use to formulate quality policies and quality objectives. - elements: structures, programmes, agreements, contracts, documents, records etc We re-define the term QAS as Food industry quality systems is an integrated set of documented food quality and food safety activities, with clearly established inter-relationships among the various activities. The objective of quality system is to provide a food company with the capability to produce a food that fulfills all quality and safety requirements   QA adds value by having a significant impact on the reputation of your brand. Simply said, dependable Quality Assurance systems assist in communicating to the customer that every effort is being made to ensure that the product is of good quality and meets the project requirements.  QA systems in the food industry are much WHY QAS more extensive in scope than quality control programs. is They include : needed? ❖inspection, testing and monitoring activities of QC programs ❖Additional activities that are devoted to prevention of food safety hazards and quality defects.   are intended to provide confidence to a food company’s management, its customers and to government regulatory agencies that the company is capable of meeting the food quality and food safety requirements.  Examples of QAS that normally used in food Quality supply systems are: GMP? GHP ? Assurance  include documents that describe operations and activities that directly related to food systems quality and food safety.  example : ISO 9000:1994 quality assurance system standard which was replaced by the ISO 9001:2000 Quality Assurance System  QA is partly a planning activity and partly a control activity  Planning activity: defining company-specific assurance objectives, translating external requirements into the quality management programme, validating the effectiveness and implementing the programme.  Control activity: collecting, analysing and evaluating information and data from the operational quality management system through verification, reviewing and audits. the safety (hazard-free products) being the quality of food required by law.  Quality Assurance Activities 1) Defining assurance objectives of a 2) Translating stakeholder requirements company into the quality management programme Stakeholders: government, retailer, customers How? Implementing programme such as GMP, HACCP, ISO22000, FSSC22000. Outcome: A quality manual = a document that includes policies, rules and procedures for achieving and assuring quality and safety.  3) Validating the effectiveness of the quality management programme to check the effectiveness of crucial control measures; Will the programme and measures lead to Quality the desired results? Investigating the effectiveness of conditions Assurance set for inactivation processes (like pasteurization, sterilization) or the cleaning Activities program by testing the efficacy of cleaning agents and disinfectants for use. Validation should occur before the actual quality and safety control measures are implemented in practice  4) Implementing the programme in an operational quality management system Organising meetings to inform personnel about the planning of the implementation and the Quality content Checking and adapting or investing in necessary Assurance facilities, equipment and documentation and record-keeping system. Activities Checking existing and (re) writing (new) standard operating procedures and work instructions Training of personnel to refresh knowledge, skills and awareness.  5) Verifying the actual performance of the quality management system Checking whether all activities/conditions meet the requirements specified in the quality management programme. Verification activities must be planned, performed on a regular basis, supported by scientific evidence or Quality experimental data. Activities are: Assurance Reviewing of records from equipment calibrations to verify measuring equipment performance Trend analysis of product and process performance Activities records Checking of training records of personnel Performing chemical and microbial analyses of products and ingredients to verify effectiveness of process at critical steps, or of incoming material control, or of cleaning and sanitation programmes.  6) Identifying and implementing corrective actions and Quality improvements Assurance Verification activities, periodic reviews and internal/external Activities audit reports  serve as a basis for defining corrective actions or improvement programmes. The major functions of the QA Department are: 1. Compliance with specifications 2. Test procedures 3. Sampling schedules 4. Records and reporting 5. Trouble shooting 6. Special problems 1. Compliance with specifications Legal requirements, industry standards, internal company standards, shelf-life tests, customers' specifications. Eg: Verifying by audit that : ⮚ the quality system requirements are being followed activity have done in a systematic manner ⮚there is objective evidence available to confirm the activity 2. Test procedures Testing of raw materials, finished products, and in- process tests. 3. Sampling schedules Utilize a suitable sampling schedule to maximize the probability of detection while minimizing workload. 4. Records and reporting Maintain all QA records so that customer complaints and legal problems can be dealt with. Eg: Corrective action Action to eliminate the cause of detected NCR or other undesirable situation 5. Trouble shooting Solve various problems caused by poor quality raw materials, erratic (inconsistent) supplies and malfunctioning process equipment; and investigate reasons for poor quality product to avoid repetition 6. Special problems Customer complaints, production problems, personnel training, short courses, etc. What are the different between QA and QC? Quality control Quality assurance (QAS) Focus on outputs Focused on process Achieved by sampling and checking Achieved by improving production (inspection) process Targeted at production activities Targeted at the whole business Emphasizes required standard Emphasizes the customer Defective products are inspected out Quality is built into the product QA:Prevent defects in products & services QC: Detect defects & correcting them A Day In The Life - Quality Manager FOOD QUALITY AND FOOD SAFETY  obligatory systems have been established to assure food safety, and are subsequently called “safety assurance systems”. These include Good Hygiene Practices (GHP), Good Manufacturing Practices (GMP) and Hazard Analysis and Critical Control Point (HACCP). Quality Assurance and Management Systems (QMS) Quality Assurance Control Points (QACP) is one of the quality assurance systems in food production, created based on the HACCP concept. In case of HACCP, Critical Control Points (eliminating hazards), parameters and their critical limits are determined3, while in QACP – Control Points (quality assurance, not safety), parameters and their critical values4. Likewise in HACCP, QACP is unique for each company and must be introduced individually for each enterprise and After implementation of GMP/GHP, HACCP and QACP systems, the next step could be to implement other quality systems, e.g. ISO- 9000. The ISO-9000 series of standards represent the requirements which have to be addressed by every enterprise to assure the reliable production and timely delivery of goods and services to the marketplace. Technological focus GMP HACCP ISO Management focus COMMON QA SYSTEMS  GMP has a legal status in the USA where it is codified in the Food and Drug Administration (FDA). The fundamentals of GMP for food Good are: Manufacturing Quality control Practice (GMP) Product meets specifications Quality assurance Systems ensure control and consistency Documentation If it is not documented, it did not happen, or it is false Verification and self-inspection  The 5 important factors of production and food processes that affect quality and safety while following GMP are: Place Premises should be clean, and equipment should be orderly arranged. Food preparation surfaces should allow for regular cleaning and should be designed to prevent food contamination. Primary materials Materials should be assessed, controlled, tested and Good recorded where contaminated, adulterated, impure raw materials should be rejected and returned. Manufacturing People Practice (GMP) Number of personnel must be in sufficient numbers, equipped with sufficient knowledge and training, qualified by education, and mature with experience to perform their respective tasks. Process The sanitation plan should include procedures for effective premise cleaning, equipment, handling the health and hygienic behaviour of personnel. Product Every product has its own specifications, which may include quantity, purity, potency and test methods. Elementary quality assurance standards and guidelines Focus Production Environment Codes and guidelines on hygienic food production Basic hygiene conditions and practices Agribusiness and food industry Production System Concept of Hazard Analysis and Critical Control Points Product safety Agribusiness and food industry Organisation and management ISO9001 standard Product and service quality management All sectors, not food specific Relevant for all actors in agri-food chain Figure 2.2: Elementary quality assurance standards, guidelines, and their focus. Prerequisites for hygienic food production Prerequisites refer to the minimum conditions, measures, and/or activities that need to be place in any food production environment to be able to produce safe and wholesome ingredients and foods. The Codex Alimentarius advises that any sector of the food chain should operate according to the Codex document on “General Principles of Food Hygiene”, use the appropriate GMP codes, and respect the relevant food safety legislation, prior to the application of HACCP principles. Intergovernmental body with more than 180 members Established by the Food and Agriculture WHAT IS THE CODEX ALIMENTARIUS?? Organization of the United Nations (FAO) and the World Health Organization (WHO) To protect the health of consumers and ensuring fair practices in the food trade. Main categories of the Codex General Principles of Food Hygiene document Primary production Design and Control of Maintenance and Establishment of  environmental facilities  operation  sanitation  personal hygiene hygiene; hygienic hygienic design various aspects of maintenance, people-related production of food requirements on control cleaning, pest aspects like health sources; handling, location, premises, measures/systems control and status, personal storage and equipment and including monitoring of hygiene, personal transport; and facilities. requirements on cleaning. behavior and maintenance, the control visitors. cleaning and hazards; incoming personal hygiene. materials; packaging; water quality; Transportation  management and Training  food its maintenance supervision; and hygiene training, and uses, product documentation. the content of information and training, checking labelling, demands the effectiveness concerning of training and consumer refreshment education. training. What are prerequisite programmes? ISO(2015) defined as “basic conditions and activities that are WHO defined prerequisite necessary to maintain a hygienic programmes as the “practices and environment throughout the food conditions needed before and during chain suitable for the production, the implementation of HACCP and handling and provision of safe end which are essential to food safety” products and safe food for human consumption” HACCP Plans 7 principles: 1) Hazard analysis 2) Determination of critical control points 3) Establishment of critical limits of CCPs 4) Establishment of monitoring system for each CCP 5) Establishment of corrective actions 6) Development of procedures for verification 7) Establishment of documentation and record-keeping.  Multiple sources of hazards as the basis for the hazard inventory Raw materials, Conditions of the Packaging, e.g. is Process equipment/ facilities ingredients and semi- food which favour packaging resistant design, e.g. are appropriate finished products as a microbial growth, to damage, tamper- time-temperature conditions source of e.g. residues of e.g. composition, proof, does it obtained, can pesticides, the initial pH, aw. contain proper equipment/facilities be content of labelling and properly cleaned and microorganisms. instructions? sufficiently controlled? Survival of Deviations in Contamination by Lay-out of design production area e.g. important process managing the equipment, is an adequate separation of raw and steps, e.g. heat- process, e.g. personnel or processed materials guaranteed? stable toxins. process delays, environment (air, technical trouble. water).  STEP 1: Develop HACCP Team Should be developed to a specific product and process; from harvesting/ processing raw materials, food manufacturing to the point of consumption. The team should be a multidisciplinary and consist of representative from each function: Quality assurance technologist/microbiologist HACCP: How fully familiar with the quality and safety requirements for the product, potential hazards and risk. to DO it? Production specialist Conversant with the product manufacturing and packing processes. Distribution specialist Fully familiar with the processes of storage and distribution through which product passes between the points of packed product storage and sale to the customer Food engineer Fully conversant with the design, operation and performance of the plant and equipment  STEP 2: Describe and Characterise the Product A detail evaluation should be made of the product’s characteristics, prescribed storage HACCP: How conditions and recommended use, identifying to DO it? as relevant. Example of the characteristics are ingredients, water activity, pH, temperature, ingredients, shelf-life, humidity, standard pattern of use, instruction to consumers.  STEP 3: Construct the Process Flow Diagram A step-by-step flow diagram of the process should be established, covering the agreed scope of the HACCP system. Engineering drawings and manufacturing HACCP: How process conditions should be included to to DO it? supplement the development of process-flow diagrams. The HACCP should verify the processing operation in the flow diagram at all stages and hours of operation, which then the team will amend the flow diagram where applicable.  STEP 4: Identify the Hazards Control The information and the data collected from the characterization of the product should be analysed to identify the associated hazards. HACCP: How The HACCP team should list all hazards that may be reasonably expected to happen at each step to DO it? from main production, processing, manufacture, and distribution until the point of consumption. Once the hazards have been identified they should be assessed in terms of severity and risk.  STEP 5: Quantify and Analyse the Hazards 3 stages of severity; high severity, medium severity and low severity. HACCP: How to DO it?  STEP 6: Identify Control Requirements, Targets and Tolerances Having identified the hazards and established their importance through the assessment of HACCP: How severity and risk, control requirements should be identified. to DO it? Then, the targets and critical limits for the control should be established. Control can only be considered to be achieved with the elimination of a hazard or its reduction to a level within the tolerance.  STEP 7: Identify CCPs and Assess Existing Controls There may be more than one CCP at which control is applied to address the same hazard. The determination of a CCP in the HACCP system can be facilitated by the application of a decision tree which indicates a logic reasoning approach. HACCP: How Control requirements, targets and tolerances should be matched to the process-flow to DO it? information and data to: Identify the position of CCPs in the process Confirm whether existing controls at CCPs meet the newly established control requirements Decide what revisions to existing controls are necessary Decide how new control requirements are to be applied Identify whether hazards will be eliminated or reduced by process stages occurring downstream. The critical control point decision tree consists of four main questions Q1: do control measures exist for the identified hazard? Q2: is the process step specifically designed to eliminate or reduce the likely occurrence of the hazard to an acceptable level? Q3: could contamination with the identified hazard occur at the step at an unacceptable level or could it rise to an unacceptable level? Q4: does a subsequent step eliminate or reduce the hazard to an acceptable level? Example of decision tree diagram  STEP 8: Establish a Monitoring System for Each CCP The team should establish criteria for the methods and frequencies of CCP monitoring. HACCP: How The date from monitoring must be evaluated by person with knowledge and authority to to DO it? carryout corrective actions when indicated. Monitoring procedures for CCPs will need to be done rapidly because they relate to on-line processes and there will be insufficient time for lengthy analytical testing. ISO9001 ISO standards are voluntary unless a business sector makes it a market requirement, or a government regulation makes it obligatory. ISO9001 – Quality Management System ISO22000 – Food Safety Management System ISO45001 –Occupational Health and Safety System ISO14000 – Environmental Management System Figure 2.3: The Quality Management Principles of ISO9001 Quality Management Principles Used as the basis for ISO9001 Principle Examples of activities Customer Recognize direct and indirect customers who receive value from the focus organization Link the organization’s objectives to customer needs and expectations Communicate customer needs and expectation throughout the whole organization Monitor customer satisfaction and take appropriate action Manage relationships with customers to achieve sustained success Leadership Communicate the organization’s mission, vision, strategy, policies and processes throughout the organization Establish a culture of trust and integrity Encourage an organization-wide commitment to quality Provide people with the required resources, training and authority to act with accountability Inspire, encourage and recognize people’s contribution Quality Management Principles Used as the basis for ISO9001 Principle Examples of activities Engagement Communicate with people to promote understanding of the importance of their individual contribution Facilitate open discussion and sharing of knowledge and experience Empower people to determine constraints to performance and to take initiatives without fear Recognize and acknowledge people’s contribution, learning and improvement Process Define system objectives and processes necessary to achieve them approach Establish authority, responsibility and accountability for managing processes Determine process interdependencies and analyse the effect of modifications to individual processes on the system as a whole Manage processes and their interrelations as a system to achieve the organization’s quality objectives effectively and efficiently A process approach means having a step-by-step sequence of actions: “Say What It Does” – document day to day operating procedures and systems “Do What It Says” – work in accordance with those procedures and systems “Prove It” – with a certification audit which confirms, from records, that the procedures and systems meet the requirements of ISO 9001 and are operated in accordance with the standard. Certification is how you show that your business has implemented this approach, but this is not the end point, the process of implementing the 8 principles using a process approach is what has been proved time and time again to transform businesses. Quality Management Principles Used as the basis for ISO9001 Principle Examples of activities Improvement Promote the establishment of improvement objectives at all levels of the organization Educate and train people at all levels on how to apply basic tools and methodologies to achieve improvement objectives Ensure people are competent to successfully perform improvement projects Recognize and acknowledge improvement initiatives. Evidence- Ensure that data and information are sufficiently accurate, reliable based and secure decision- Analyse and evaluate data and information using suitable methods making Ensure people are competent to analyse and evaluate data as needed Make decisions and act based on evidence, balanced with experience and intuition. Quality Management Principles Used as the basis for ISO9001 Principle Examples of activities Relationship Determine relevant interested parties (such as suppliers, partners, management customers, investors, employees and society as a whole) and their relationships with the organization. Determine and prioritise interested party relationship that need to be managed. Establish relationships that balance short-term gains with long- term considerations. Measure performance and provide performance feedback to interested parties, as appropriate to enhance improvement initiatives Encourage and recognize improvements and achievements by suppliers and partners. Figure 2.4: Main sections of the ISO9001 standard with its typical requirements GROUP TASK How to implement ISO in your company/ organization Create a process flow  ISO 9001 CERTIFICATION Portray Responsibilities in Give satiety to the competent the job scope are customers services clear High commitment The leadership Good quality of the and vision is system is organization transparent and practiced towards quality efficient services Step to Excellency Common private standards British Retail Consortium (BRC) International Featured Standards ISO22000 Food Safety System Certification 22000 (FSSC22000) Safe quality food GlobalG.A.P. Food Scientist – Quality Assurance Manager Career Profile: Quality Assurance Laboratory Technician THANK YOU