4.3 Situation three In the Sample Preparation area, procedure CRP 12 revision 4, originally issued and approved by the Laboratory Manager, is pinned to the wall above the bench where the sample preparation is done. There is a hand-written amendment to the instruction which has been initialled 'AGM'. In response to the assessor's query the guide says that these are the initials of one of the Sample Prep area technicians. The assessor further establishes that the Laboratory Manger was unaware of this amendment. The assessor has previously note that the quality manual stated 'all changes to documents shall be reviewed and approved only by the same function that performed the original review and approval'. Description of the nonconformity (Max 3 marks): Relevant evidence (Max 3 Marks): ISO/IEC 17025:2017 clause and requirement (Max 1 Mark): Note: - For identifying the scenario as a nonconformity - For overall clarity 2 Marks are awarded 1 Mark is awarded OR - Complete your answer on the following page. Situation one: - Give your reason(s) for thinking there is not yet sufficient evidence to report your findings as a nonconformity. - Describe how you would investigate further to determine conformity or nonconformity. Include investigation trails you would follow and specific examples of evidence you would seek and for what purpose. Four investigation trails you would follow, including, evidence sought and purpose. (Max 2 Marks for each investigation trail): Inree assessment situations are described. For each, review the information and evidence in the scenario and decide if there is sufficient evidence to report the findings as a nonconformity with the assessment criteria, ISO/IEC 17025 (current issue). Either - Where you determine there is sufficient evidence, complete the nonconformity report template. Marking scheme for a nonconformity: - For correctly identifying the scenario as a nonconformity - For a clear description of the nonconformity - For correctly quoting relevant evidence - For correctly identifying the relevant ISO / IEC 17025 requirement (1 mark) - Overall clarity of the nonconformity report Note: if you raise a nonconformity report when there is no nonconformity, 0 (zero) marks will be awarded. OR - If you think there is not yet sufficient evidence to report your findings as a nonconformity, complete the investigation template, clearly stating; - Your reason(s) for thinking there is not yet sufficient evidence to report your findings as a nonconformity - How you would investigate to determine conformity or nonconformity. Include investigation trails you would follow and specific examples of evidence you would seek and for what purpose. Note: if you complete the investigation template for a situation where there is evidence that a nonconformity exists, a maximum of 7 marks may be awarded as follows: - Providing a valid reason why there is insufficient evidence for a nonconformity. - Providing relevant investigation trails as above