Sample collection, receipt and anonymisation Records management Premises, equipment and facilities Non-conformance Training See references for applicable regulations Develop audit plans Define the aims and objective of the audit Determine the scope Determine the resources required Determine the audit methodology Determine timelines for generating an audit report and audit response report Decide who are the key stakeholders who should receive the audit report and audit response report, and describe what the stakeholders will receive (e.g. full report or summary) Ensure the plan is reviewed by the Audit Manager or delegate; where the Audit Manager writes the audit plans it is recommended to have the audit plan reviewed by another suitably qualified individual Plan audit Develop tools Inform auditee of and confirm scope, inputs, timing and resources required Ensure the submission of documents/information by auditee pre-audit as requested by the auditor Clarify who should receive the audit report alongside the auditee Perform audit Perform checks against plan and review of key processes through document review and interviews Escalate significant issues within required timeframes and following the applicable standards and regulations and, where appropriate, that are outlined in the topic-specific QMS. Note: if significant issues are identified and need further exploration the can deviate from the plan It is recommended that the auditor with auditee to discuss findings Ensure the auditee is informed of the timeframes surrounding the generation of the report and audit response report Write audit report Consider a review by the Audit Manager (or delegate) as outlined, where appropriate, in the relevant topic-specific QMS Ensure the audit report is sent to the auditee within the set timeframes and that copies are forwarded to the pre-agreed relevant parties Audit Response Report Auditee provides audit response report within the agreed timeframe, where applicable Review auditee’s response report where applicable. Where required request further clarification; where the response report addresses the findings appropriately progress to audit closure. Audit closure Consider generating an audit certificate to be forwarded to the auditee and relevant parties to be added to their files. Forward relevant information to key stakeholders; stakeholders may discuss and decide if organisational CAPA is required as per their local procedures. File all relevant documentation
Sample collection, receipt and anonymisation Records management Premises, equipment and facilities Non-conformance Training See references for applicable regulations Develop audit plans Define the aims and objective of the audit Determine the scope Determine the resources required Determine the audit methodology Determine timelines for generating an audit report and audit response report Decide who are the key stakeholders who should receive the audit report and audit response report, and describe what the stakeholders will receive (e.g. full report or summary) Ensure the plan is reviewed by the Audit Manager or delegate; where the Audit Manager writes the audit plans it is recommended to have the audit plan reviewed by another suitably qualified individual Plan audit Develop tools Inform auditee of and confirm scope, inputs, timing and resources required Ensure the submission of documents/information by auditee pre-audit as requested by the auditor Clarify who should receive the audit report alongside the auditee Perform audit Perform checks against plan and review of key processes through document review and interviews Escalate significant issues within required timeframes and following the applicable standards and regulations and, where appropriate, that are outlined in the topic-specific QMS. Note: if significant issues are identified and need further exploration the can deviate from the plan It is recommended that the auditor with auditee to discuss findings Ensure the auditee is informed of the timeframes surrounding the generation of the report and audit response report Write audit report Consider a review by the Audit Manager (or delegate) as outlined, where appropriate, in the relevant topic-specific QMS Ensure the audit report is sent to the auditee within the set timeframes and that copies are forwarded to the pre-agreed relevant parties Audit Response Report Auditee provides audit response report within the agreed timeframe, where applicable Review auditee’s response report where applicable. Where required request further clarification; where the response report addresses the findings appropriately progress to audit closure. Audit closure Consider generating an audit certificate to be forwarded to the auditee and relevant parties to be added to their files. Forward relevant information to key stakeholders; stakeholders may discuss and decide if organisational CAPA is required as per their local procedures. File all relevant documentation
UoB-GEN-AUD-SOP-001%20Audits%20v2.0%20for%20web.docx