Introduction
The essential purpose of an EASA compliance audit is to support the maintenance of the regulatory approval.
Quality Assurance Compliance Audits are a systematic and independent comparison of the way the system process or objective is met. Using the observations made during this audit, as “objective evidence” a comparison is thus made against the standard, generating non-conformities or corrective actions in the event of any discrepancy.
The audits should be documented with a checklist which shows the details of the audit standard or audit criteria which are being applied to the audit.
Note 1 Quality Assurance Audits are Prescriptive in as much as they are always referenced against a standard – means compliant.
Note 2 Safety Assurance Audits are Performance in as much as they are related to an expectation – means they are typically subjective in this regard.
Quality Assurance Compliance Audits, Best Practice Considerations
a) For each Audit is appointed an auditor who plans each audit separately.
b) The auditor shall prepare an audit checklist for each audit. (The checklist shall include all items required to show compliance with the regulatory requirements related to the subject matter)
c) The Audit Planning Control Document should include the following:
• Auditee;
• Purpose/scope of the audit;
• Reference documents;
• Auditors;
• Auditee representatives to be notified;
• Timeframe;
• Audit checklist(s).
d) Any previous audits of the area in question shall be taken into account in audit preparation.
e) The auditee shall be notified at a minimum of one week in advance of an internal audit.
f) Externally Audits shall be mutually agreed typically initial contact is made 4 to 6 weeks out and confirmation 2 weeks before accomplishment.
g) Audits shall start with a pre-audit meeting and end with a closeout meeting.
h) The purpose of the pre-audit meeting is to review and confirm the objectives together with any considerations which should be taken into account.
Findings
a) A non-conformity is raised when there is evidence of failure to comply with an established and required standard or regulation. (all findings must be evidence based)
b) All Findings “Must” be accepted and agreed by the auditee
c) The timescale for the closure of audit findings should also be achievable and agreed (based on urgency and or exposure /importance)
d) The adequacy of the corrective action and identification of Root Cause and associated mitigations shall be reviewed and accepted by the auditor (if necessary, through re-audit)
Close-Out Audit Meeting
a) The purpose of the post-audit meeting is to present the preliminary findings of the audit and to provide an opportunity for comment/discussion
b) A detailed presentation of all findings is typically provided to the auditee with 5 business days.
c) An Audit Report is produced for the Quality Assurance System Records typically within 10 business days which shall include the following details :
• Unique audit reference number identifiable in the Audit Schedule;
• The auditee;
• Purpose/scope of the audit;
• Reference documents;
• The auditors;
• Date(s) of the audit;
• A brief summary of the audit;
• Details of any non-conformity and other findings.
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