During the ISO 9001-2015 audits, auditors will run into various situations to determine whether they have...

 

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During the ISO 9001-2015 audits, auditors will run into various situations to determine whether they have sufficient objective evidence of nonconformity and report their findings. Based on the audit in situations A, B, C and D, answer the below items for each situation: i) Determine whether the situation is under NONCONFORMITY or NOT. ii) Determine the applicable ISO 9001-2015 clauses in each situation. Explain. iii) If the answer in (i) is NONCONFORMITY, classify whether it is MAJOR or MINOR and provide your justification iv) If the answer in (i) is NOT NONCOMFORMITY, then state your reasons. a) Situation A the process audit, the auditor requested the production manager to provide the final inspection report for the finished goods before being sent to the customer. When the auditor verified the report's details, he found out that one production lot was rejected in the inspection record. However, no actions were taken for the rejected lot, but they still proceeded to ship to the Du customer. b) Situation B The auditor referred to the supplier's incoming inspection report for the company's component purchased from their supplier. From the incoming inspection report, the auditor encountered a few reoccurrences of problems that happened within a month. When the auditor asked the incoming quality engineer what action had been taken to prevent the problem, the engineer showed that they had issued the non-conformity report to the supplier and are now waiting for the supplier to reply with the countermeasure. The engineer also informed that they perform 100% inspection for the component from this supplier before the non-conformity report is closed. c) Situation C The auditor verified the standard operating procedure (SOP) that is related to staff training and development in the human resource (HR) department. When the auditor requested the training need analysis report that stated in the first process in the SOP, the HR manager replied that due to the short on staffing in the department, the department skipped the process this year and HR followed the training programme from last year. No report can be presented to the auditor. d) Situation D During the certification audit for ISO 9001-2015, when the auditor requested how to control the product quality and address the risk in the production process before sending it to the next process, the production manager replied that they did not manage the risk for the procedure. The product manager told the auditor that it is sufficient to control the product quality, and process risk assessment is not important to maintain the quality management system. According to the manager, risk assessment is not required from the standard. He answers that they have prepared the inspection criteria for the operator to judge the product quality before the product sends to the next process. During the ISO 9001-2015 audits, auditors will run into various situations to determine whether they have sufficient objective evidence of nonconformity and report their findings. Based on the audit in situations A, B, C and D, answer the below items for each situation: i) Determine whether the situation is under NONCONFORMITY or NOT. ii) Determine the applicable ISO 9001-2015 clauses in each situation. Explain. iii) If the answer in (i) is NONCONFORMITY, classify whether it is MAJOR or MINOR and provide your justification iv) If the answer in (i) is NOT NONCOMFORMITY, then state your reasons. a) Situation A the process audit, the auditor requested the production manager to provide the final inspection report for the finished goods before being sent to the customer. When the auditor verified the report's details, he found out that one production lot was rejected in the inspection record. However, no actions were taken for the rejected lot, but they still proceeded to ship to the Du customer. b) Situation B The auditor referred to the supplier's incoming inspection report for the company's component purchased from their supplier. From the incoming inspection report, the auditor encountered a few reoccurrences of problems that happened within a month. When the auditor asked the incoming quality engineer what action had been taken to prevent the problem, the engineer showed that they had issued the non-conformity report to the supplier and are now waiting for the supplier to reply with the countermeasure. The engineer also informed that they perform 100% inspection for the component from this supplier before the non-conformity report is closed. c) Situation C The auditor verified the standard operating procedure (SOP) that is related to staff training and development in the human resource (HR) department. When the auditor requested the training need analysis report that stated in the first process in the SOP, the HR manager replied that due to the short on staffing in the department, the department skipped the process this year and HR followed the training programme from last year. No report can be presented to the auditor. d) Situation D During the certification audit for ISO 9001-2015, when the auditor requested how to control the product quality and address the risk in the production process before sending it to the next process, the production manager replied that they did not manage the risk for the procedure. The product manager told the auditor that it is sufficient to control the product quality, and process risk assessment is not important to maintain the quality management system. According to the manager, risk assessment is not required from the standard. He answers that they have prepared the inspection criteria for the operator to judge the product quality before the product sends to the next process.

Answer rating: 100% (QA)

a Situation A i NONCONFORMITY ii ISO 90012015 Clause 824 Control of Nonconformity Explanation The pr... View the full answer