Audit evidence: At XYZ Plastics, you review maintenance records for Injection Molding Machine #4. The procedure requires weekly thermocouple calibration. Last month’s log shows three missed calibrations. The maintenance manager says, "We were short-staffed. Machine #4 ran fine anyway." No deviation request was raised. Machine #4 produced parts for a medical device client requiring FDA compliance.
Draft the nonconformity statement, classify it (Major/Minor), and identify which ISO clause (for ISO 9001:2015) is violated.
7.1.5.1 – “The organization shall determine and provide the resources needed to ensure valid and reliable monitoring and measurement results.” And 7.1.5.2 a – “Calibrated or verified at specified intervals.”
The best answer is always the one that protects audit integrity, follows the audit plan, and cites the exact clause from the standard. Need more help? Join the IRCA LinkedIn group “Lead Auditor Exam Prep” where verified tutors post weekly scenario challenges. Good luck on your journey to certification.
Rationale: ISO 19011 Clause 6.2.2 states that the audit plan should consider "the results of previous audits." Before contacting the auditee or building checklists, the lead auditor must review historical data to identify risks and legacy issues. Q2: An auditee tells you, "I know the procedure says to check temperature every hour, but we only check it when the alarm sounds because we trust the system." This is an example of: A) Minor nonconformity B) Major nonconformity C) Opportunity for improvement (OFI) D) Observation
Rationale: This is a systemic failure to follow a defined procedure. If the procedure is a documented requirement (e.g., ISO 9001 Clause 7.5.3), ignoring it constitutes a significant breakdown. IRCA defines a major NC as "absence or total breakdown of a system" that could lead to product/service failure. Q3: As a lead auditor, you discover that your brother is the Quality Manager at the facility you are about to audit. What should you do? A) Proceed but disclose the relationship in your report B) Recuse yourself immediately from the audit team C) Ask the auditee if they are comfortable with you auditing D) Send a junior auditor to handle that specific department
Your passing score (typically 70% for MCQs, 75% for case studies) depends not on memorizing answers, but on to unique situations. Use this guide as your roadmap, cross-check with ISO 19011:2018, and practice mock NCRs daily.
Audit evidence: At XYZ Plastics, you review maintenance records for Injection Molding Machine #4. The procedure requires weekly thermocouple calibration. Last month’s log shows three missed calibrations. The maintenance manager says, "We were short-staffed. Machine #4 ran fine anyway." No deviation request was raised. Machine #4 produced parts for a medical device client requiring FDA compliance.
Draft the nonconformity statement, classify it (Major/Minor), and identify which ISO clause (for ISO 9001:2015) is violated. irca lead auditor exam questions and answers verified
7.1.5.1 – “The organization shall determine and provide the resources needed to ensure valid and reliable monitoring and measurement results.” And 7.1.5.2 a – “Calibrated or verified at specified intervals.” Audit evidence: At XYZ Plastics, you review maintenance
The best answer is always the one that protects audit integrity, follows the audit plan, and cites the exact clause from the standard. Need more help? Join the IRCA LinkedIn group “Lead Auditor Exam Prep” where verified tutors post weekly scenario challenges. Good luck on your journey to certification. The maintenance manager says, "We were short-staffed
Rationale: ISO 19011 Clause 6.2.2 states that the audit plan should consider "the results of previous audits." Before contacting the auditee or building checklists, the lead auditor must review historical data to identify risks and legacy issues. Q2: An auditee tells you, "I know the procedure says to check temperature every hour, but we only check it when the alarm sounds because we trust the system." This is an example of: A) Minor nonconformity B) Major nonconformity C) Opportunity for improvement (OFI) D) Observation
Rationale: This is a systemic failure to follow a defined procedure. If the procedure is a documented requirement (e.g., ISO 9001 Clause 7.5.3), ignoring it constitutes a significant breakdown. IRCA defines a major NC as "absence or total breakdown of a system" that could lead to product/service failure. Q3: As a lead auditor, you discover that your brother is the Quality Manager at the facility you are about to audit. What should you do? A) Proceed but disclose the relationship in your report B) Recuse yourself immediately from the audit team C) Ask the auditee if they are comfortable with you auditing D) Send a junior auditor to handle that specific department
Your passing score (typically 70% for MCQs, 75% for case studies) depends not on memorizing answers, but on to unique situations. Use this guide as your roadmap, cross-check with ISO 19011:2018, and practice mock NCRs daily.
আমাদের সফটওয়্যার এবং রিসোর্স আপলোডিং এর কাজটি বর্তমানে চলমান আছে। আমাদের টিম সর্বাত্নক চেষ্টা করছে, খুব দ্রুত রিসোর্স আপডেটিং এর কাজটি শেষ করে একটি পরিপূর্ণ ফ্রি রিসোর্স কমিউনিটি তৈরী করার।