Organisations are required by ISO 9001:2015 to use suitable means to identify outputs when it is necessary to ensure the conformity of products and services. By:
The reference to “outputs” rather than “products” indicates the requirements are intended to be applicable to service oriented organisations as well manufacturers. The requirements can be broken down into three distinct elements:
In a production environment this should include from receipt of raw materials / components / subassemblies, through all process stages, any in process or final storage and finally into despatch and shipping. This can be achieved via any appropriate means such as physical stamping / printing etching on the product itself, labelling of product with individual printed / hand written / bar code labels, electronic tags or batch / lot identification travellers / route cards etc. (See also article 8.7 Control of nonconforming outputs.)
This may be relatively straight forwards in fully automated / cellular manufacturing environments. (The physical location indicates at what point in the process it is up to.) Other processes will however, require methods to positively identify the relevant production stages either manually via documented information (checked off batch cards / travellers process steps, appropriate application of identification at key stages (such as “Passed inspection” stickers or labels) or other electronic systems for tracking production batches / runs / lots.
The level of traceability an organisation applies to a given product or service may be derived from regulatory requirements such as in the aerospace or pharmaceutical industry, industry standards and customer requirements (such as automotive,) or defined by the organisation based on the nature of the product or service being provided. IE: risk and economic considerations. (The potential additional cost of implementing very high levels of traceability such as to an individual component or batch of raw material level, should be balanced against the potential consequences of failure and subsequent required action such as whole lot recall. (See article 8.7 Control of nonconforming outputs.)
Depending on the level of traceability required various methods may be employed from individual component unique stamping / bar coding to whole lot / batch identification combined with documented information whether manually or electronically gathered from suppliers / subcontractors and during processing. Traceability information (records) should be subsequently stored and retrievable, (See also articles 5.1, 5.2 and 5.3 Documented information.)
Without careful education and training traceability activities can be misinterpreted as “none added value” by personnel and as a result, essential identification / recording may be discontinued without any obvious immediate consequences. (See article 7.3 Awareness point 4,) This may be easily picked up by an auditor in an operations based audit.
Production and manufacturing based organisations utilising human input into product traceability should therefore ensure appropriate awareness and training has been communicated and carefully monitor (audit) the implementation of the traceability process. Where possible, a risk-based approach should also be taken to reduce the level of human interaction. IE via automatic processes such as stamping labelling / electronic scanning etc. (See also article 8.5.1 Control of production and service provision point 7.)
Service based businesses should also note the applicability of traceability requirements and as appropriate, consider the level of traceability required, how it is to be executed and records to be maintained.
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David Barker CQP MCQI