FPC maintains declared performance during manufacturing. One successful sample differs from controlling routine output under consistent conditions.
A general quality system may support shared processes, but product-specific FPC requirements still apply. Determine tests, frequency, sampling and performance records from the technical specification. ISO 9001 certification does not automatically create a required FPC certificate or complete product assessment.
Product and location boundaries follow the certificate and programme. Other sites may use different materials, equipment and processes. A shared quality manual does not establish assessment of every factory. Clarify notification and review needs for new locations with the body.
Start from the applicable specification and assessment system; mandatory controls cannot be reduced arbitrarily. Risks and previous results may require additional monitoring. Define methods, intervals, acceptance criteria, ownership and action on nonconforming results in the control plan.
No. Responsibilities remain for sample selection, identity, transport and result evaluation. Check laboratory methods and scope. Reports must connect to the correct batch or type. Link external results to actual production decisions.
Determine affected scope from batches, common inputs and operating conditions. Follow technical rules for segregation, rework or rejection. Deviations do not all have the same consequence, but a later favourable result cannot erase the first finding before its cause is understood.
Identify why the gap occurred and effects on products made during it. Never record unperformed tests as completed. Plan additional verification and action under relevant conditions. An approaching visit does not remove the evidence gap; allow for further review in the schedule.
Share the subject, organisation or product, target market, current evidence and target date. The team can then separate consultancy, official fees, independent evaluation and realistic timing.
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