TCS426F Audit, Inspection and Certification PDF

TC S426F Audit, Inspection and Certification 1 Set 1 Topics Introduction of conformity assessment activities; Illustrates different stages of Inspection Inspection process 2 3 Conformity Assessment...

TC S426F Audit, Inspection and Certification 1 Set 1 Topics Introduction of conformity assessment activities; Illustrates different stages of Inspection Inspection process 2 3 Conformity Assessment Activities According to ISO/IEC 17000 conformity assessment activities (合 格評定活動) are used to demonstrate whether an object is fulfilling specified requirements. Object can be material, product, service, installation, process, system, person, or organization or any combination thereof. The three major activities used for conformity assessment are defined below: Testing (測試) Inspection (檢驗) Certification (認證) 4 Conformity Assessment Activities Conformity assessment activities like testing and inspection can be conducted by first, second or third parties:  First party conformity assessment activities are performed by the person or organization that provides the object (i.e. object manufacturer or supplier). E.g: Internal QC laboratory.  Second party may refer to a person or organization which would like to purchase or use the object, or as a customer or the representative of a customer who shows interest in the object. E.g: Users of product, or potential customers seeking to rely on a supplier’s management or organizations representing those interests.  Third party conformity assessment activities are performed by a person or body that is independent from either first or second parties and has no user interest in the object. 5 E.g: Independent laboratory – not owned by buyer or manufacturer. Testing Testing is the determination of one or more characteristics of an object of conformity assessment, according to a procedure. Testing can be applied to materials, products or processes. Testing can be conducted by the first, second or third parties. Product conformity test BS EN 60529 Degree of protection provided by enclosures (IP Code) 6 Testing Pros and Cons for testing Pros:  Direct evaluation to the conformity of product(s). Cons:  Requires representative samples.  Result valid to the tested batch of product only, cannot prove all individual product complying with test requirement.  Not involve in the control of the manufacturing processes.  Different results may be observed by using different testing methods. 7 Inspection Inspection is the examination of a product design, product, process or installation and determination of its conformity with specific requirements, or, on the basis of professional judgment, with general requirements. The requirements for inspection are generally simple. Inspection can be conducted by first, second or third party. Manufacturing process conformity Example: Examining the net weights of shampoo liquid in bottles (i.e. total weight – weight of bottle) from the same production batch to see whether they all contain 700 ml ± 20 8 ml of shampoo. Inspection Pros and Cons for inspection Pros:  Direct evaluation to the conformity of product(s), based on statistical significant sampling  Low risk of sample variations within the same production batch Cons:  Difficult to determine complex requirements.  Results valid to the inspected batch of products only.  Not involve in the control of the manufacturing processes.  The judgements may be subjective and varied by inspectors, 9 manufacturers and customers. Certification Certification is the issuance of a conformance statement by a third party (usually a certification body) that a product, process, system or person has demonstrated the fulfillment of specified requirements. Example: An independent certification body conducted an audit on Company A and has concluded that the quality management system (QMS) of Company A fulfilled the requirements of ISO 9001 10 Example of certificate: A product which has been tested by the third party and demonstrated to comply with some European standards. 11 Photo source: https://www.electricaltest.com.cn/glow-wire-tester-zlt-gtr_p22.htm Value of Certification The value of certification is the degree of confidence and trust that is established by an impartial and competent evaluation by a third- party. Parties that have an interest in product certification include, but are not limited to:  The clients of the certification bodies (i.e. product manufacturers or service providers);  The customers of the organizations whose products are certified (e.g. buyers);  Government authorities;  Non-governmental organizations (NGOs); and  Consumers and the general public. 12 Value of Certification Degree of confidence and trust – by an impartial and competent evaluation by a third-party. Increase the confidence to the company/service/ product’s quality Create business opportunities when management system or products being certified  Some retailers and dealers prefer or require the products they sell to be certified. Gain marketing advantages A certified product may display the trademark indicating that the product has undergone evaluation and testing to verify that the product will performed as indicated. Enhance company’s reputation and image. Reduce liability and rejects of products. 13 Certification Pros and Cons for System Certification (e.g: ISO 9001) Pros:  Assure the quality, minimize the risk of rework through the control of processes.  Low risk of product variations. Cons:  ISO 9001 did not specify the product’s requirements, and it may vary from customers due to different needs. Additional testing/ inspection may require to determine whether 14 the products meet the requirements. Declaration of Conformity Declaration of conformity (DoC) is an issue of statement, based on a decision demonstrated by the first party that the objects fulfil the specific requirements. Pros: Low cost (self declaration, simple processing) Cons: Risk is unknown, as it maybe not involve any conformity assessment activities to support the declaration 15  Table 1.1 provides an overview of different conformity assessment activities. 16 17 Inspection An inspection (檢驗) is, generally, an organized examination or formal evaluation exercise. In engineering activities inspection involves the measurements, tests, and gauges applied to certain characteristics in regard to an object or activity. The results are usually compared to specified requirements and standards for determining whether the item or activity is in line with these targets, often with a standard inspection procedure in place to ensure consistent checking. Inspections are usually non- 18 destructive. Terminology in Inspection Sample - A subset of a batch that is typically drawn at random. Producer - The party who produces or creates the good or service of interest. Customer - The party who purchased goods or services from the producer Lot, batch - The number of collection items. 19 Inspection Plan To establish an inspection planning document, below factors should be considered: Inspection method Inspection sequence – when to inspect Characteristics to be inspected, such as by attributes or variables Acceptance criteria and definition of defects Data to be records What kind of equipment and facilitates are required 20 Inspection Plan Project scope and customer’s needs Significant characteristics of the items Consistency of quality by the manufacturing methods and processes (e.g. manual) Availability of reference samples, visual aids (e.g. pantone colour), technical drawings and specifications Inspection practices for similar products Resources 21 Scheduling Inspection Inspection always adds the cost on product, therefore, frequency and criterial check points should be well planned. Usually, some manufacturers will conduct inspection: Before a covering process Before an irreversible process Before a costly operation And, typical inspection are carried out on: Raw materials Purchased parts 22 Finished products How much to inspect ? The amount of inspection can range form visual inspection of limited attributes on selected items to 100% inspection of a few variables with equipment, which is a balance of cost an risk of defective products. Low cost, high volume items (e.g: plastic bags, soaps, pens etc.) may require less inspection processes.  Cost associated with passing defective items is quite low  Dissatisfaction of customer for defective items is less likely  Process that product these items may be highly reliable, defects is comparative low. High cost, low volume items that have large cost associated with passing 23 defective items often require more intensive inspection such as airplanes and vehicles. Four Types of Quality Inspection Services Each inspection is carried out at a different stage and each stage is vital to the overall process of quality control and supply chain management. The typical quality control inspection process includes four primary steps.  Pre-production inspection (PPI)  During production inspection (DPI)  Pre-shipment inspection (PSI)  Container loading inspection (CLI) Only the most sensitive projects require all four types of inspection. Depends on the requirement and risks identified by the customers, generally, generally, only one or two of above mentioned are used. 24 25 Pre-production Inspection Pre-production inspections (PPI) is to highlight quality risks before the start of manufacturing or at the very beginning of final assembly. When to conduct a pre-product inspection? 26 Pre-production Inspection The pre-production inspection can focus on the product processes. This can ensure the products are manufactured in the right track and meet buyer’s specifications. What is checked during a PPI ?  Materials/components: to prevent using non-compliance materials / components, inspector can carry out prelim checking on item’s colours, sizes, weight, technical value etc. via the procedure of : - visual checking - tested by laboratory - conduct document review. 27 Pre-production Inspection Prototype: Inspector can check the prototype against photos, drawings and technical drawings provided by the buyers. The prototype can then be used as a reference for production.  Making the first product: to check whether the factory is capable of making products that respect specifications. Processes of mass production: to ensure the production is implemented correctly and can product consistence product. Factory’s production lines and capability Factory’s facilities and equipment 28 Pre-production Inspection Any limitation of PPI? The first pieces coming out of the production line are not necessarily a good reflection of average quality, especially when there are lots of manual operations. A during production inspection might be more useful. Sometimes the whole cycle takes several weeks, so the inspector cannot see any finished product at all. It might be impossible to verify, or even get an idea about, the conformity to specifications just by looking at in-process inventory. 29 30 During Production Inspection During production inspection (DPI) also known as DUPRO, is a quality control inspection conducted while production is underway. It allows the buyer to have an idea of average product quality at early of production cycle. This step is particularly useful for products that are in continuous production that have strict requirements and when quality issues have been found prior to manufacturing during an earlier production cycle. Effective for new products or change of manufacturer, and seldom used in re-order item by the same manufacturer. 31 During Production Inspection DPI inspections take place when some units are completed so that any deviations can be identified, have feedback given, and any defects can be re-checked to confirm they have been corrected. It enables manufacturer to confirm that quality, as well as compliance to specifications is being maintained throughout the production process. Provides early detection of any issues requiring correction thereby reducing delays and rework. 32 During Production Inspection What is checked during DPI ? Non-conformity to specification  All the relevant aspects of the product ( component, assembly, aesthetics, function, size, label…) except quantity. Visual defects  Based on the sampling plan, the inspector selects and checks some products/ packaging, and then compares the number of defects according to the AQL limits. On-site test(s)  Some simple tests can be done by the inspector in the factory ( instead of sending samples to a laboratory). 33 E.g: functional check of remote control car During Production Inspection Any limitation of DPI? Final quantity not know, so DPI should be followed by a pre- shipment inspection , to confirm quantity together with the average quality. Defect products, especially those produced at the early stage of manufacturing, may be hided by the producer and then add back to the shipment batch after the DPI, if there is no final random inspection conducted. Unavailable of final packaging. Labeling and packaging may not be checked as the packaging accessories usually received at the later 34 stage of production. 35 Pre-shipment Inspection Pre-shipment inspection (PSI) are an important step in the quality control process and the method for checking the quality of goods before they are shipped. It takes place at the end of production. PSI ensures that production complies with the specifications of the buyer. This inspection process is conducted on finished products when at least 80% T&C Standards TC S345F Selected E&E of the order has been packed for shipping. And the whole shipment quantity should be finished and available for sampling, so that the cartons can be counted. Random samples are selected and inspected for defects against the relevant standards and procedures. 36 Pre-shipment Inspection It can also be used to determine the total quantity of products. However, it may be too late if issued have been found in this stage. Therefore a DPI is usually used together with the pre-shipment inspection for new products/ supplier, to avoid finding disasters at the last minute. Usually takes place in the factory, rather than in the forwarder’s warehouse. So it is performed before the goods are sent out of the factory. 37 Pre-shipment Inspection What is checked during PSI ? Quantity verification Style, colour/ size specification Functions and safety of products Package details Shipping marks …..etc 38 39 Pre-shipment Inspection Any limitation of PSI? No 100% guarantee  it is conducted on samples drawn randomly, not on the whole quantity. There is always possible that findings are not applicable to the whole shipment, even if the so-called “normal’ or “tightened” levels are followed.  Some dishonest factory can even substitute a small amount defective products just before shipment. Too late  If only final random inspection is conducted, it may be too late significant defective found. Re-work or even re-produced may 40 require a long time to complete. 41 Container Loading Inspection Container loading inspection (CLI) typically takes place at the shipper’s factory or warehouse. The inspection is carried out to make sure the goods are correctly handled and safely loaded into the shipping containers for safe transportation and delivery to the final destination. Like the pre-production inspection, it is seldom used. But it can be a worthwhile option on some specific case. It can ensure that the right kind of products are shipped out in the right quantity, when the importer places no trust in his supplier or when several suppliers bring their products for consolidation. 42 Container Loading Inspection This process includes evaluating the condition of the shipping container, verifying all the product information, quantities, and packaging compliance. Container loading inspection includes several steps: 1. Conformity of products  The inspector checks the quantity of the goods to make sure it matches the specification so that the correct number of goods are shipped off. The inspector also checks the quality of the goods to make sure they are in the right condition. 2. Inspecting the packaging of the goods The inspector checks the packaging of the goods to make sure the material will protect the goods during shipping and that the labels are correct. Some buyers 43 may require a specific packaging material for fragile goods and this needs to be verified. Container Loading Inspection 3. Supervising the loading process and inspecting containers and vehicles  The inspector supervises the loading of the goods to make sure nothing is damaged in the process. Also, an inspection of the condition of shipping containers and vehicles is carried out to make sure they are intact, safe, and properly sealed prior to transport. 4. Recording loading conditions and compiling a report  The inspector records loading conditions such as whether to minimize possible issues on the road. When the entire inspection process is completed, a detailed report with photos and information is 44 provided to the importer. Container Loading Inspection Any limitation of CLI? Time for inspection is relatively rush. May not be feasible to conduct a prefect random sampling for product conformity inspection. In case of critical defects or significant amount of major defects found, nothing can be repaired at this stage, unless the shipment is suspended. 45 46 Step 1: Communication of Requirements The buyer describes his product based on the quantity, components, assemble, aesthetics, function, size, labeling packaging, etc. If possible, an approved sample would be submitted for the inspecting team’s reference A comprehensive inspection plan will be generated by the inspection body, which outlines the methods and procedures required for conducting the on inspections. It also provides necessary product conformance characteristics regarding appearance workmanship function, safety and packaging. etc. The inspection plan shall be reviewed and approved by buyer. 47 Inspection Methods Inspection methods shall be included of: Define what to be inspected Determine the required methods and procedure Specify equipment used if need, such as tools, measuring devices. Accuracy and resolution (if applicable) shall be clearly stated. Inspect the attributes or measure the variables Compare with the standard Evaluate if the process in control or out of control Record the observation and all results 48 Product Inspection Checklist An “inspection criteria sheet” or inspection checklist is the best way for the importers to clarify their product requirement, and it is also for both supplier and any inspection staff that might check an order before shipping. A product inspection checklist is basically a written guide for the products’ contents, packaging, color, barcodes, appearance, possible defects, functions and special requirements. 49 Product Inspection Checklist Contents – the exact contents of the package. (E.g: A Barbie doll with 1pc dress, 1 pair shoes, 1 handbag, 1 hair accessory, I pc use manual.) Packaging – describe in detail how the item is packaged, such as how many small packages in the big carton box. And how does the individual package look like, weight and dimensions. Colour – pantone colours of the components, items and packaging. Barcodes- barcode type, QR code or any coding on the item or packaging. Appearance- contains information of critical, major and minor defects for master carton, individual packaging and item. Function- including the functions of each item, and the method of inspection. (E.g: Toy car: left/ right/ forward/ backward movement of car mentioned in manual.) Special requirements – any requirement apart from the normal function. (E.g: Drop test from 1 feet above a cement floor) 50 Photos – for all components, individual packaging and master carton. Classification of Defect Classification of defect is a vital step for determining if goods should pass or fail inspection base on considering the quantity and severity of different types of defects found. Professionals typically classify quality defects into three main categories: minor, major and critical. The nature and severity of a defect determines in which of the three categories it belongs.  Minor defects are usually small, insignificant issues, usually does not adversely affect its required marketability, sale-ability, form and function of the item. In most cases, the customer wouldn’t even notice a minor defect on a product. And the customer wouldn’t likely return an item due to a minor defect alone.  Major defects are those which could adversely affect the marketability, sale-ability, function, performance or appearance of a product. These defects are readily noticeable by the customer. And these defects would likely cause a customer to return the product, lodge a complaint or request a refund in response.  Critical defects are the most serious of the three defect types. Critical defects render an item poses the possibility of causing injury or harm to the user in the vicinity of the product. These defects put businesses at serious risk of product liability issues, lawsuits and product recalls. Many importers have a “zero tolerance” policy for critical defects in 51 their orders commensurate with this risk. An item will often fail product inspection if a single critical defect is found within the order. Examples of defects defined Garments, in particular, tend to be more vulnerable to quality defects because of the labor- intensive production processes involved in their manufacturing. Minor defect: Untrimmed thread – these are a common quality issue in garment manufacturing. Factories can easily rework this defect by simply cutting the excess threads. You might also classify untrimmed threads as a major defect depending on your customers. Major defect: Missing stitches – these typically appear due to a fault with the sewing machine or an operator error. Missing stitches impact the visual appearance of the product and can even affect seam strength, making this a more serious quality issue. Critical defect: Needle found in item – needles can pose a hazard to the end user if they end up in the finished goods. This quality issue is almost always classified as a critical defect. And the presence of one 52 such defect typically results in the item failing inspection. Step 2: On Site Inspection 53 Step 2: On Site Inspection 54 Step 3: Inspection Report Once the inspection is completed, the inspector will prepare and issue a report which is compiled with a pass/fail result, an overview of key findings, and a detailed account of the inspection results. Some reports include photo showing all inspection points. Key findings including of ( but not limit to) product information, quantity of product, visual defects, conformity requirement and on-site test results. 55