9.2.2.4 Product audit
- Must audit products using customer-specific required approaches at appropriate stages of production and delivery to verify conformity to specified requirements.
- Where not defined by the customer, the organization defines the approach to be used.
Customer requirement--> Production--> Customer satisfaction
What it entailed?
People
Process
Documentation
As we mentioned earlier in my other post, I love to use a simplistic system. I need to rally a team of auditor, identify our auditee and schedule time for audit. Product audit is best to be performed during regular hours on real-time. Auditor must understand the production process, which typical start with incoming material, then move to production, inspection or testing and finally shipping.
Each of the process there is at least an owner that perform the task. The owner is auditee that you will interact in the process. Ask several questions that related to the process, I would recommend to pull several samples (products) and verify the part#, lot# and their specification. Review the product and match it to its specification (print, material sheets or measurement data). Ensure correct revision is used on every sample. Check for test equipment and verify their validity, make sure they are calibrated and within calibration date. You may need to keep a copy of each objective evidence or record down the report reference so you can refer to it later on when you write up audit report.
Product audit is more extensive than internal audit, so you may require to follow where the audit trail leads you. For instant, you may need to review incoming test result for material used to build the product. You may also require to check if operators training record is up to date.
You may repeat the similar system on each process (incoming, production, inspection, shipping etc)
Here's a simple template for product audit:
Product Audit
Auditor(s) name:Date:
Process name: XYZ
Product information- verify product#, revision#, product print and specification, operators name(s)
Test data-Review test data or result to make sure product has been verified as required on the customer or engineering print. (raw material test result, product test result etc)
Calibration-Check that test equipment used on each station is within calibration.
Traceability-Product will need to have complete traceability from incoming raw material to product shipped out to customer. (lot, production log or electronic log sheet etc.)
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