CQI and IRCA Examination Paper 2 for Quality Management Systems Auditor Training Courses (PR328 & PR345 ISO 9001)[ET]

Section one – five questions worth two marks each – maximum 10 marks

Question 1.1

In the context of a quality management system and ISO 9001:2015, explain, in your own words, the difference between a ‘risk’ and an ‘opportunity’.

(2 marks)

Question 1.2

List two ISO 9001:2015 clauses (clause number and title) that support the quality management principle – ‘evidence-based decision making’.

(2 marks)

Question 1.3

ISO 9001:2015 requires an internal audit programme to be planned, taking into consideration ‘the importance of the processes and changes affecting the organization’.

Explain, in your own words, what is meant by this phrase.

(2 marks)

Question 1.4

ISO 9001:2015 refers to monitoring and measurement.

Using examples, explain in your own words, the difference between the terms ‘monitoring’ and ‘measurement’.

(2 marks)

Question 1.5

Explain, in your own words, the difference between ‘design verification’ and ‘design validation’.

(2 marks)

Section two – four questions worth five marks each – maximum 20 marks

Question 2.1

You wish to establish that the auditee organisation has implemented an effective internal communication process in accordance with ISO 9001:2015.

a) State two topics that the organisation should communicate internally.

(2 marks)

Question 2.1

You wish to establish that the auditee organisation has implemented an effective internal communication process in accordance with ISO 9001:2015.

b) List three methods an organisation could use to facilitate effective internal communication.

(3 marks)

Question 2.2

As an auditor an important professional behaviour is the ability to remain open-minded.

a) In your own words, briefly explain what being open-minded means in an audit situation.

(3 marks)

Question 2.2

As an auditor an important professional behaviour is the ability to remain open-minded.

b) Support your explanation with an example related to an audit situation.

(2 marks)

Question 2.3

Outline five examples of audit evidence that together could represent an absence of top management leadership and commitment.

(5 marks)

Question 2.4

In an audit situation:

a) Briefly describe an objective of reviewing the auditee’s management system documented information as part of the preparation for an audit.

(3 marks)

Question 2.4

In an audit situation:

b) List two other actions to be taken during the preparation stage of an audit.

(2 marks)

Section three – three questions worth 10 marks each – maximum 30 marks

Question 3.1

You are conducting an external audit with ISO 9001:2015 as audit criteria. The next item is a meeting with top management to audit the quality policy, quality objectives and management commitment.

Outline in a checklist how you will perform this audit by developing a series of ten audit checkpoints that together cover these three areas. For each checkpoint, identify examples of the audit evidence you would want to gather and give the appropriate ISO 9001:2015 reference.

Note: 1 mark will be awarded per audit checkpoint, with 0.5 mark for the supporting evidence and 0.5 mark for the appropriate ISO 9001:2015 reference.

(10 marks)

Question 3.2

You are conducting an ISO 9001:2015 audit of the Human Resource department.

You ask the Human Resource Manager how the organisation ensures that personnel performing work are suitably competent. He replies that all personnel are qualified and trained.

You then sample the records of five people working in the customer service department. On each person’s record is a list of the academic qualifications they hold, as well as a list of the in-house training courses they have attended.

You note that all five people have attended the same courses: an induction course, a behavioural safety course, a managing people course, and a basic IT course.

a) Explain what a concern here may be.

(2 marks)

Question 3.2

You are conducting an ISO 9001:2015 audit of the Human Resource department.

You ask the Human Resource Manager how the organisation ensures that personnel performing work are suitably competent. He replies that all personnel are qualified and trained.

You then sample the records of five people working in the customer service department. On each person’s record is a list of the academic qualifications they hold, as well as a list of the in-house training courses they have attended.

You note that all five people have attended the same courses: an induction course, a behavioural safety course, a managing people course, and a basic IT course.

b) Based on the concern you identified in Part A above, briefly describe four audit trails you would follow to determine conformity or nonconformity to the requirements of ISO 9001:2015. For each, identify the applicable clause(s) of ISO 9001:2015 and any audit evidence you would gather.

(8 marks)

Question 3.3

You are conducting an audit of management review. You examine the minutes of the last three management review meetings that cover a period of two years. You note they have largely been via presentation by the Quality Manager to top management of operational cost issues and nonconformities identified through internal audit. The minutes do not indicate any actions resulted from the review.

You consider this does not meet the requirements of ISO 9001:2015 clause 9.3.

a) In relation to clause 9.3, identify and explain two possible nonconformities in this scenario.

(4 marks)

Question 3.3

You are conducting an audit of management review. You examine the minutes of the last three management review meetings that cover a period of two years. You note they have largely been via presentation by the Quality Manager to top management of operational cost issues and nonconformities identified through internal audit. The minutes do not indicate any actions resulted from the review.

You consider this does not meet the requirements of ISO 9001:2015 clause 9.3.

b) Taking the scenario into consideration, not your possible nonconformities, identify three different clauses of ISO 9001:2015 that you would want to discuss with top management. For each clause selected briefly outline what your discussions will cover.

(6 marks)

Section four – three questions worth 10 marks each – maximum 30 marks

Questions in this section are designed to test your ability to analyse audit situations, evaluate audit evidence and apply knowledge of the audit criteria correctly.

Learners are required to either:

• Complete the nonconformity report template.

          Marking scheme for a nonconformity:

• For correctly identifying the scenario as a nonconformity  (2 marks)
• For a clear description of the nonconformity  (3 marks)
• For correctly quoting relevant evidence  (3 marks)
• For correctly identifying the relevant ISO 9001 requirement  (1 mark)
• Overall clarity of the nonconformity report  (1 mark)

Note: if you raise a nonconformity report when there is no nonconformity, 0 (zero) marks will be awarded.

OR

• Complete the audit investigation template, clearly stating:
• Your reason(s) for thinking there is not yet sufficient evidence to report your findings as a nonconformity  (2 marks)
• How you would investigate to determine conformity or nonconformity, including audit trails you would follow and specific examples of audit evidence you would seek and for what purpose.  (8 marks)

Note: If you complete the audit 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.  (2 marks)
• Providing relevant audit trails as above.  (5 marks)

4.1 – Audit situation one:

You are auditing an organisation that delivers training on behalf of their main customer, a government department. Requirements are defined in a contract issued each year to the training organisation’s Contract Manager.

Appendix A of the contract shows the projected number of students for the next twelve-month period. You notice that section 1 of the main body of the current contract includes a requirement to comply with Government Procedure 853, which specifies arrangements for maintaining the security and confidentiality of students’ personal data.

The Contract Manager tells you he is not aware of this requirement and is not familiar with Government Procedure 853. You confirm there is no reference to Procedure 853 in the original contract. The contract manager explains that when they accepted the latest contract, they only reviewed the projected number of students in the new Appendix A.

You establish the training organisation is following its own procedures for maintaining the security and confidentiality of students’ personal data. These are the same as when the original contract was agreed.

If you think there is sufficient evidence to report your findings as a nonconformity:

• Complete the nonconformity report on the following document and upload:  QMS-AUDIT-1 

OR

• Complete the audit investigation template.

Questions in this section are designed to test your ability to analyse audit situations, evaluate audit evidence and apply knowledge of the audit criteria correctly.

Learners are required to either:

• Complete the nonconformity report template.

          Marking scheme for a nonconformity:

• For correctly identifying the scenario as a nonconformity  (2 marks)
• For a clear description of the nonconformity  (3 marks)
• For correctly quoting relevant evidence  (3 marks)
• For correctly identifying the relevant ISO 9001 requirement  (1 mark)
• Overall clarity of the nonconformity report  (1 mark)

Note: if you raise a nonconformity report when there is no nonconformity, 0 (zero) marks will be awarded.

OR

• Complete the audit investigation template, clearly stating:
• Your reason(s) for thinking there is not yet sufficient evidence to report your findings as a nonconformity  (2 marks)
• How you would investigate to determine conformity or nonconformity, including audit trails you would follow and specific examples of audit evidence you would seek and for what purpose.  (8 marks)

Note: If you complete the audit 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.  (2 marks)
• Providing relevant audit trails as above.  (5 marks)

4.2 – Audit situation two:

You are auditing the process for the control of monitoring and measuring resources in a component manufacturer. You see a box containing parts accompanied by the relevant production paperwork. You examine the paperwork, which appears to be complete and accurate.

This shows a repeat order. You see a comment: “Customer supplied gauge number A123 to be used to verify that the components meet the requirements given in drawings XB 113 revision 2.” The gauge is numbered A123 and appears to be in good condition although well used. You ask the Production Operator about the calibration status of the gauge.

The operator responds: “I do not hold such details with me. I was given the gauge together with a copy of the customer’s order and their drawings. I use it in accordance with the customer’s instructions and the components are all acceptable according to the gauge.”

If you think there is sufficient evidence to report your findings as a nonconformity:

• Complete the nonconformity report on the following document and upload:  QMS-AUDIT-2

OR

• Complete the audit investigation template.

Questions in this section are designed to test your ability to analyse audit situations, evaluate audit evidence and apply knowledge of the audit criteria correctly.

Learners are required to either:

• Complete the nonconformity report template.

          Marking scheme for a nonconformity:

• For correctly identifying the scenario as a nonconformity  (2 marks)
• For a clear description of the nonconformity  (3 marks)
• For correctly quoting relevant evidence  (3 marks)
• For correctly identifying the relevant ISO 9001 requirement  (1 mark)
• Overall clarity of the nonconformity report  (1 mark)

Note: if you raise a nonconformity report when there is no nonconformity, 0 (zero) marks will be awarded.

OR

• Complete the audit investigation template, clearly stating:
• Your reason(s) for thinking there is not yet sufficient evidence to report your findings as a nonconformity  (2 marks)
• How you would investigate to determine conformity or nonconformity, including audit trails you would follow and specific examples of audit evidence you would seek and for what purpose.  (8 marks)

Note: If you complete the audit 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.  (2 marks)
• Providing relevant audit trails as above.  (5 marks)

4.3 – Audit situation three:

During your audit of the sales department, you notice a recent contract, number A12345, has been accepted by the Sales Manager. Sales staff have developed a work order and passed it to the production planning department.

You ask to see evidence that the contract has been reviewed. You are shown a letter to the customer accepting the order, signed by the Sales Manager.

You are also shown a report from the Production Manager (number Prod D123), dated two weeks after the Sales Manager’s letter of acceptance. This report shows that the production department have not been able to meet this specification for three months. It therefore requires the sales staff to ask the customer to accept some modifications to their original requirement and an extended delivery time. None of these issues were mentioned in the Sales Manager’s letter of acceptance.

You ask to see the response from the customer and confirm that the customer has accepted the modifications and the revised delivery date, but also note in a letter from the customer that they are dismayed about the changed delivery date.

If you think there is sufficient evidence to report your findings as a nonconformity:

• Complete the nonconformity report on the following document and upload:  QMS AUDIT 3

OR

• Complete the audit investigation template.