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7.5.3 Identification and traceability
Where appropriate, identify product by suitable means throughout product realization.
Identify the status of product with respect to monitoring and measurement requirements
Control and record the unique identification of the product, (where traceability is a requirement).
Note: Configuration management is a means for maintaining identification and traceability in some industry sectors.
Key Explanation Points and Tips:
ÞThere are three distinct control requirements specified here.
ÞProduct identification - means knowing the identity of (yours or customer supplied) product from - incoming receipt of materials; raw material storage; use in production; work in progress; finished product storage; and delivery of product to the customer. Product identification can be controlled using physical and electronic methods.
ÞProduct status - means knowing the quality status (good or bad) of materials and product through each of the above stages. Product status can be controlled using physical and electronic methods.
ÞUnique Product Identification - is not a mandatory requirement under ISO 9001, unless contractually required by customers or regulatory bodies. In certain industry sectors such as the automotive or aerospace or pharmaceutical industry, unique product identification is mandatory for safety, regulatory and risk management reasons.
This usually involves keeping detailed records of product manufacturer - material; equipment; personnel; processes; production; inspection and test details, etc., for individual products or production batches.
ÞThese records help to trouble-shoot product and process problems; resolve customer complaints; and enables continual improvement of product and process. In many instances, it also reduces cost, risk and use of resources by narrowing the problem down to a specific cause or instance. Depending on the product, the OEM may specify the degree of unique identification and traceability required.
ÞWhile this clause does not call for a specific documented procedure, these controls may be included in your product realization processes through your product quality plans; work instructions and other specific documentation.
Examples of product identification and test status include physical tags, bar code labels linked to computer records; MRP systems tracking specific production runs/lots; automated production transfer processes, etc.
ÞPerformance indicators (to measure the effectiveness of processes that control identification and traceability) may include - reduction in identification errors and omissions; product quality status errors and omissions; and traceability errors and omissions.
