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Performing your supplier and contractor audits - Developing , Managing and Performing your shared audits - Training and Assessing your auditors - Training your team on GMP ...
More information on shared audit methodology : 6 key steps
Identification of suppliers
- Signature of confidentiality agreement

- Sharing information related to audit supplier needs

- Identification by HCS-QA of potential shared audits

- Information to the relevant customers
Establish a Quality Agreement with customers
This Quality Agreement is signed between HCS-QA and each customer concerned for confidentiality reasons and should include :
- The scope of the audit

- The objectives of the audit

- The standard and products

- The name and qualification of the auditor

- Commitment of the auditor related to the absence of conflict of interest with the auditee
Audit agenda
The agenda takes into account potential specific items to consider during the audit.
Audit on site
The audit is performed according to the agenda. The audit includes the review of product processes, Quality Management system and specific customer items.
Audit report
The report is issued to each customer and to the supplier asking for the action plan. Specific customer items are included into the relevant audit report.
Evaluation of CAPA plan
The action plan is provided to HCS-QA for an evaluation before being issued to customers.
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