ISO 9001 Training
Understanding ISO 9001:2008
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ISO 9001 TrainingUnderstanding ISO 9001:2008
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7 Product Realization 7.5 Production and Service Provision 7.5.3 Identification and Traceability Where appropriate, the organization shall identify the product by suitable means throughout product realization. The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization. Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records (see 4.2.4). NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained. |
ISO 9001 Training - Key Explanation
Points and Tips:
There are
three distinct control requirements specified here.
Product 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.
Product 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.
Unique 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.
These 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.
While 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.
Performance 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.