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Clause 8 Operation

8.5.2 Identification and traceability

Clause Criteria

The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of products and services.
The organization shall identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision.
The organization shall control the unique identification of the outputs when traceability is a requirement, and shall retain the documented information necessary to enable traceability.

Explanation

This criteria requires an organization to have an established process for the identification and traceability of outputs, in terms of the monitoring and measurement requirements at all stages of production, to enable the organization to demonstrate conformance to requirements, e.g.;
physical part marking,
labeling, tags, bar codes,
signage, visual indicators,
part segregation,
lay down areas,
storage racks.

Questions:
Have the expected outcomes of processes been defined and communicated so that in process validations can be effective?
How are monitoring and measurement requirements established throughout operations to provide for effective identification and validation of expected outcomes?
Is documented information available to support effective identification and traceability of expected outcomes throughout processes?

Hardcopy worksheets, spreadsheets, software applications, or other mechanisms for tracking workflows, need to provide for traceability to be able to assure conformance to customer and business requirements.

Chief Explainer:

Phil Byrne

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