Assessment follows how process changes affect performance. The control plan and actual records should use the same technical basis.
Sampling locations, methods, frequency, acceptance criteria and decision ownership should also be clear. Define control of affected goods after failure. Compare the plan with implementation records. A list of names does not establish timely testing of the correct product.
Boundaries must reflect input and process relationships so affected goods can be found. One time or quantity definition may not suit every product. Connect samples with dispatched goods. Unclear batches can unnecessarily enlarge withdrawal or reassessment scope.
Review effects on declared characteristics and settings. Determine new type assessment or additional controls under the specification. Earlier initial results do not automatically represent other materials. Keep change approval, first production and test records connected.
No. Production-control certification and method competence or accreditation are different. Check the required test's method, scope and acceptance conditions separately. A document in another field is not automatic authority for a product's specific testing need.
Performance variation may become impossible to connect with production conditions. Trace critical settings, reasons and approvals as appropriate. Match samples to periods and products. A correct current setting does not explain earlier output; investigation needs that history.
Disclose capacity, product types, control equipment and operating records. Distinguish existing surveillance from assessment of the new line. Allow time for required tests and evidence. Do not present its products as automatically certified before the additional scope decision.
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