1 Organisation: Nonconformity no: Correction Immediate fix/disposition of an existing nonconformity 2 with completion dates. Attach supporting documents. Root cause analysis: Check applicable key factor(s): Describe results of root cause Personal competence analysis and check applicable Adequate procedure(s) key factor(s) that best define Available resources 3 Organisation culture/attitude the root cause. Human error Risk assessment and mitigation (if appropriate) Note 1: Investigate how /why this happened Identify and justify which root cause(s), if removed or changed, will prevent recurrence. – Note 2: Use the organisation procedures for risk assessment and list conclusion/s and mitigation/s (if applicable) Proposed Corrective Action Plan: 4 Effective solutions to prevent recurrence Note 3: In the rare occasion when a corrective action plan to prevent recurrence is considered not applicable, justification is needed (N/A is not acceptable) Note 4: A proposal for corrective action shall be submitted to ICETRA (the applicable inspector) within the date specified in the nonconformity report. The action plan should detail the root cause analysis, specify correction measures (immediate fix) and how the proposed corrective action arrangements prevent recurrence of similar deficiencies and re-establish compliance with requirements. 5 Acceptance of proposed corrective action Quality/Compliance manager or his/her deputy accepting the Signature: proposed corrective action. Name and date: For ICETRA use only 6 ICETRA acceptance/rejection of the Accepted Rejected proposed corrective action Comments/explanations (if applicable) Inspector name and date: Signature:
1 Organisation: Nonconformity no: 2 Correction Immediate fix/disposition of an existing nonconformity with completion dates. Attach supporting documents. 3 Root cause analysis: Describe results of root cause analysis and check applicable key factor(s) that best define the root cause. Check applicable key factor(s): Personal competence Adequate procedure(s) Available resources Organisation culture/attitude Human error Risk assessment and mitigation (if appropriate) Note 1: Investigate how /why this happened – Identify and justify which root cause(s), if removed or changed, will prevent recurrence. Note 2: Use the organisation procedures for risk assessment and list conclusion/s and mitigation/s (if applicable) 4 Proposed Corrective Action Plan: Effective solutions to prevent recurrence Note 3: In the rare occasion when a corrective action plan to prevent recurrence is considered not applicable, justification is needed (N/A is not acceptable) Note 4: A proposal for corrective action shall be submitted to ICETRA (the applicable inspector) within the date specified in the nonconformity report. The action plan should detail the root cause analysis, specify correction measures (immediate fix) and how the proposed corrective action arrangements prevent recurrence of similar deficiencies and re-establish compliance with requirements. 5 Acceptance of proposed corrective action Quality/Compliance manager or his/her deputy accepting the proposed corrective action. Name and date: Signature: For ICETRA use only 6 ICETRA acceptance/rejection of the proposed corrective action Accepted Rejected Comments/explanations (if applicable) Inspector name and date: Signature:
SGS_001_Proposal.docx