AMI-CON ensures that all parts supplied through the QMS are not counterfeit and are original bonafide materials. This is done using the following processes and measures.
- Relevant training is given to all staff who deal with duties related to ‘new supplier set up’, ‘new product set up’, booking in of goods and final inspection/dispatch. Authorised signatories undertake a rigorous training program and only become authorised and issued an inspection stamp upon completing an error free induction period, measured, and monitored via the internal Near Miss Incident Log – D013
- All potential suppliers are duly required to complete a CF004 ‘Supplier Quality Assurance Questionnaire (SQAQ)’, where within the document at section 11 the following statement and request are made: (This information is captured and controlled within Merlin within ‘supplier maintenance’- user page 1 and ensures that the supplier and therefore the parts procured from said supplier are controlled to ensure compliance and release to the relevant quality statement and to reduce the opportunity of counterfeit parts being supplied and to ensure that downstream reporting of any potential obsolesces is adopted).
- Full batch traceability and product conformity is controlled for all, based on product rating criteria Level A, C and U materials. Refer to Sections 8.5.1 and 8.5.2 of the Quality Manual.
- Verification of non-counterfeit products and materials is also conducted, where applicable at the point of receiving the goods by means of verifying the material has met the requirements to conform to the manufactures internal production specification documented on the certificate of conformity (viscosity profile, lap sheer results, shore hardness etc.). Once verified as conforming the C of A is stamped by the inspector scanned and filled. If an issue is discovered the operative proceeds to send the supplier a CF052 – Supplier Discrepancy Form and then moves to the supplier returns procedure, if necessary.
- Any identified non-conformance to requirements of the purchase order, packaging, labeling and specification should be queried with the supplier immediately using CF052 – Supplier Discrepancy form and the product/ material should be quarantined until such time the discrepancy has been resolved or the material rejected.
- Any suspected counterfeit materials or parts are immediately quarantined and dealt with as illustrated in process flow 11.4.4 – Disposition of non-conforming Product (CD079) and 11.2.2 – Product Recall (CD071) (Refer to SOP057).
AMI-CON have put together procedures and controlled documents to prevent suspected unapproved parts:
- CD051: Product Quality Approval Process Flow
- CD052: Product Quality Approval Criteria
- SOP051: Control of Non-Conforming Product