Nonconforming product identifying

Is product identified in a way that indicates its conformance or nonconformance with regard to inspections and tests performed ... 

As stated previously, traceability is fundamental to establishing and eliminating the root cause of nonconforming product and therefore it should be mandatory in view of the requirements for Corrective Action. Providing traceability can be an onerous task. Some applications require products to be traced back to the original ingot from which they were produced. In situations of safety or national security it is necessary to identify product in such a manner because if a product is used in a critical application and subsequently found defective, it may be necessary to track down all other products of the same batch and eliminate them before there is a disaster. It happens in product recall situations. It is also very important in the automobile and food industries in fact, any industry where human life may be at risk due to a defective product being in circulation. 

Inspection and test status is either reject or accept . There are no gray areas. If not fully conforming the product should be rejected and identified as such. If conforming the product should be accepted and identified as such. If a nonconforming product is later deemed acceptable, the identification should be changed but this can lead to problems. 

Not all product intended for delivery may in fact have passed the required inspections and tests as the customer may have waived some of the requirements for that particular delivery. Hence the reference to release under an authorized concession. Identifying product correctly will help preclude any unidentified or nonconforming product from being delivered, used, or installed. However, the only way to make certain is to remove them from areas where they may be inadvertently dispatched, used, or installed. 

The only sure way of preventing inadvertent use of nonconforming product is to destroy it, but that may be a little drastic in some cases. It may be possible to eliminate the nonconformity by repair, completion of processing, or rework. A more practical way of preventing the inadvertent use or installation of nonconforming or unserviceable products is to identify the product as nonconforming or unserviceable and place in an area where access to it is controlled. These two aspects are covered further below. 

Segregation is another important requirement and not only for nonconforming product as specified in clause 4.13. Segregation is vital in many industries where products can only be positively identified by their containers. It is also important to prevent possible mixing or exposure to adverse conditions or cross-contamination. Examples where segregation makes sense are ... 

A product that does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with a nonconforming product are defined in a documented procedure. 

The nonconforming products are identified and segregated by labels to indicate their pending disposition. 

Products or services that do not conform to the quality standards are identified and the supplier notified so that a remedial action is taken. The code gives procedures for dealing with nonconforming products, along with the necessary corrective action. 

Any raw material, intermediate or finished excipient found not to meet specifications must be clearly identified and segregated to prevent inadvertent use or release for sale. A record of nonconforming product should be maintained. All incidence of nonconformance should be investigated to identify the root cause. This investigation should be documented and correction made to prevent recurrence of the problem. 

All member states should establish easily identifiable and effective surveillance authorities and experts. A proactive approach to market surveillance should be promoted to limit the risks of dangers from nonconforming products. The objectives of market surveillance must be active and effective enforcement, rapid communication on defective products, and equal protection for all citizens. Just as standards are the foundation for safe product design, so is effective market surveillance the cornerstone for securing consumer confidence in the Single Market. 

How do you ensure that, when needed, personnel have the organizational freedom to identify and record product, process, and quality system problems, provide solutions and initiate action to prevent the occurrence and recurrence of any nonconformities ... 

The standard requires that where incoming product is released for urgent production purposes, prior to verification, it shall be positively identified and recorded in order to permit immediate recall and replacement in the event of nonconformity to specified requirements. 

It would be considered prudent to prohibit the premature release of product if you did not have an adequate traceability system in place. If in fact any nonconformities in a component will be detected by the end product tests, it may be worth allowing production to commence without the receipt tests being available, in which case the tests will only be confidence checks and not verification checks. If only one product is received and released prior to verification one would think that, as the requirement applies prior to verification, there is no need to positively identify the product to permit recall because you would know where it was if you found it to be nonconforming. However, the nonconformity may have been reported to you by the supplier after delivery. The standard does not stipulate when and by whom the nonconformity may have been detected. If you lose the means of determining conformity by premature release, don t release the product until you have verified it is acceptable. 

The standard requires the supplier to identify the inspection and test status of product bp suitable means, which indicate the conformance or nonconformance of product with regard to inspection and tests performed. 

On the labels themselves you should identify the product by name and reference number, specification and issue status if necessary and either a statement of the nonconformity or a reference to the service or nonconformity report containing full... 

This element describes systems used to identify and address nonconforming materials or products. For ESH/PSM, this might refer to not meeting relevant standards or specifications for materials and equipment or to audit findings of noncompliance. 

A bottom-up approach may be used to follow up on a specific quality problem identified from trend analyses, product nonconformities, adverse experiences, customer complaints, or other sources of quality data. Starting with quality records associated with the problem, the auditor will work his or her way up through the... 

An example of a robust process is the design, development, and operation of a nonconformance process. Regulations require an operational process to identify, document, and correct nonconformances occurring in licensed pharmaceutical manufacturing facilities for approved products. Companies spend significant human... 

Initiate action to prevent the occurrence of product nonconformity Identify and record any product or service problems Initiate, recommend, or provide solutions through designated channels Verify the implementation of solutions... 

The inspection and test status of the product or parts are clearly identified by marking, tags, labels, inspection records, test reports, shop travelers, physical location, or other suitable means that indicate the conformance or nonconformance of the product. Records show the inspection authority that determined the status. 

The records of product and system defects are analyzed to identify and eliminate potential areas of nonconformance. Nonconformance handling programs are made and followed. 

Audits are conducted as a management tool for assessing the quality level of an operation. They are used to identify nonconformance and to make corrective actions as needed, and prevent reoccurrence of potentiail problems that can adversely affect a product. Audits are conducted internally and externally. Supplier audits may be directed for cause , such as a customer complaint, for change control, or for a product problem. Audits may be scheduled on a regular basis (e.g., every 3 years) for suppliers of key or critical materials. 

Qause 8.3 is on control of nonconformity. This is a requirement to identify rmd control product that is in nonconformance and to take appropriate action to see that such product does not reach the customer. The next subclause requires data dealing with the quality system to be collected and analyzed. These data include customer satisfaction and dissatisfaction, conformance to requirements, characteristics of processes and products, emd suppliers. 

Hopefully, by inspection of the process (Figure lA) potential concerns may be identified and dealt with before results are obtained. Traditional QC inspects the product (here the results) and nonconforming output initiates feedback to the process (Figure IB). As discussed above, analytical science rarely has the luxury of knowing whether the output is of sufficient quality until the client complains. 

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