DQM Core Units
Quality Audit flashcards
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Complete Flashcard Reference
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What are the three types of audit, and who conducts each?
First-party (internal): the organisation itself, or someone on its behalf, for internal purposes. Second-party: a party with an interest in the organisation, such as a customer auditing its supplier. Third-party: an independent body, typically for certification against a standard.
What are audit criteria, and why are they agreed before the audit begins?
The reference against which audit evidence is compared: procedures, internal guidelines, national or international standards and organisational policies. Agreed in advance so findings are objective rather than the auditor's personal opinion. An audit with no stated criteria produces opinions, not findings.
What is the difference between an audit programme and an audit plan?
Audit programme: the organisation's overall schedule of audits over a period, covering every process or area in rotation. Audit plan: the detailed plan for one specific audit, with its scope, criteria, schedule and team.
What do the opening meeting and the closing meeting of an audit do?
Opening meeting: confirms the audit plan with the auditee, introduces the audit team and agrees communication channels for the audit. Closing meeting: presents the findings to the auditee, confirms they are understood and agrees next steps before the audit report is issued.
What are the four categories of audit finding?
Conformity: evidence shows the requirement is being met. Nonconformity: evidence shows a requirement is not being met, graded major or minor. Observation: a point worth noting that is not itself a nonconformity. Opportunity for improvement: an area that conforms but could be made more effective.
What three parts must every written nonconformity contain?
The requirement, the objective evidence found, and the departure. Without the evidence it cannot be verified; without the requirement it is an opinion. Name a process, not a person, or the finding invites a dispute about blame instead of a corrective action.
What is the difference between a correction and a corrective action?
Correction: immediate action to fix the specific nonconformity found, treating the symptom (the wrong label is replaced). Corrective action: action to eliminate the root cause so it does not recur (the labelling procedure is changed, the operator is trained). A complete response to a nonconformity needs both.
What is the purpose of a follow-up audit?
To verify that corrective actions were actually implemented and were effective, closing the loop the original audit opened rather than leaving a corrective action plan unverified on paper.
How is audit trend analysis read?
By process and by direction across cycles, never by the total: a steady total can hide one process worsening and another improving. A recurring nonconformity in the same area or category points to a systemic issue that a single audit's corrective action will not fix. A flat count and a rising count both indicate failure, of different kinds.
What does management review look at, and what does it decide?
Top management periodically reviews the quality management system's overall performance, with audit results among the key inputs, alongside customer feedback, process performance and risk status. It decides whether the system needs strategic-level change.
What is a first-party audit?
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A major customer checks that a supplier meets agreed quality standards before signing a large contract. What type of audit is this, and why?
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What is a third-party audit?
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What does the audit scope define, and what is it matched to?
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State four objectives of a quality audit.
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Where do the criteria for a quality audit come from?
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What does stating the criteria in the audit plan allow a finding to be?
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What resources does an audit need?
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What competence does an audit team need collectively?
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Which audit resource is most often underestimated, and what is the usual planning mistake?
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What is the role of the lead auditor?
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What does an auditor do?
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Who is the auditee, and what is expected of them?
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Why might an audit team include a technical expert?
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What risk does the opening meeting remove, and what does it establish?
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Why are findings presented at a closing meeting before the report is written?
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What is the purpose of an audit checklist?
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Why is an audit checklist called a memory aid and not a script?
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What makes a nonconformity major?
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What is a minor nonconformity?
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When is a finding graded an observation?
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An auditor notes a process that conforms but could be more efficient if its steps were sequenced differently. How is this graded, and does it need a corrective action plan?
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Why must audit findings be graded consistently?
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What should an audit report include?
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Which audit finding requires a corrective action plan?
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Who prepares a corrective action plan, when, and what does it state?
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What happens to an organisation that only corrects nonconformities?
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A machine was set incorrectly and produced a defective batch. The technician resets it. What further action is needed?
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Which tool from Statistical Quality Control is commonly used to find the root cause for a corrective action?
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A process's nonconformities rise from 1 to 11 over four audit cycles. What does this indicate?
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A process's nonconformities fall from 9 to 1 over four audit cycles. What does this indicate, and what follows for the audit programme?
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A process raises 5 or 6 nonconformities every audit cycle. What does the steady recurrence mean?
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A process raises exactly 3 nonconformities every cycle. What should the auditor check?
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How is the reduction achieved by a corrective action measured, and how is it verified?
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Beyond a management review meeting, what does a periodic review of the system itself assess?
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Where do audit findings that point to genuine opportunities go?
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How is an improvement action closed off?
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How to revise with these cards
- Answer out loud or on paper before you turn the card: recalling is what fixes it.
- Go through the deck in short sessions of ten to fifteen minutes, every day.
- Shuffle once you know the order, so you are not answering from memory of the sequence.
- When a card catches you out, read the chapter it links to, then try the topic in a past paper.