QM system inspection (CoP-Q)
CoP-Q means: the inspection of procedures and processes at the approval holder.
It should be ensured that the approved products are manufactured with constant quality in conformity with the corresponding type approval. In particular, the production and testing procedures and processes as well as the effectiveness of the arrangements taken to ensure product conformity are checked.
CoP-Q measures are planned according to the following criteria:
- The existence of a proper certification of the QM system (proper certification means that the certificate was issued by a certification body designated by the KBA as a technical service. This certification should include the continuous verification of type-approval-relevant requirements)
- Time interval to previous system (CoP-Q) and product inspections (CoP-P)
- The kind of the approval objects
- Results from previous inspections
In addition, event-related criteria are also taken into account. This could be information from the type approval or product safety department. Results of product inspections (CoP-P) could also give a reason for a system inspection.
In preparation for an on-site inspection, the approval holder is informed about
- The intended inspection
- The need for company-specific information on the production and testing procedures and processes
- The date of the inspection including a proposal for the procedure and a statement of the cost
The fee for the conformity inspection correspond to GebOSt No. 119.1 plus travelling expenses.
A CoP-Q inspection addresses the following points:
- Inspection of storage, production and testing areas
- Examination of relevant procedure/process documentation (specifications)
Checking knowledge about the obligations as a approval holder, e.g:
- Regulation of responsibilities with regard to production and testing of the approved objects
- Knowledge of current legal specifications with regard to the requirements for the approval object
- Regulations on measures to be taken if non-conform products are identified in production
- Regulations on measures to be taken if non-conform products are identified that have been placed on the market and/or pose a risk (recall)
- Regulation on the storage and availability of evidence of product conformity (CoP test reports)
- Procedures for change management if approval-relevant issues are affected
- Procedures for directing non-conformities both internally (production, testing, shipping) and externally (customers, suppliers, authorities)
- Checking the manufacturer's records on product conformity
- Reconciliation of results and clarification of open points
Non-conformities are recorded in finding reports. Suitable corrective measures and proofs as well as deadlines for feedback on implementation are agreed to correct the non-conformities.
If the final assessment is positive, the approval holder receives a confirmation.
The "Report on the procedures guaranteeing Conformity of Production" (Report on CoP) is an essential part of the initial assessment for the KBA type approval procedure and of the periodic inspection of type approval holders. It is regularly prepared by the KBA (CoP-Q) and/or the technical services designated for this purpose as part of the assessment of the approval-relevant requirements.