CQI and IRCA Examination Paper 3 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

ISO 9001:2015 requires that ‘personnel…shall be competent’.

Explain, in your own words, what ‘competent’ means.

(2 marks)

Question 1.2

In the context of managing an audit programme, briefly explain, in your own words, the concept of risk-based auditing.

(2 marks)

Question 1.3

Explain, in your own words and using examples as appropriate, the difference in meaning of the terms, ‘responsibility’ and ‘authority’.

(2 marks)

Question 1.4

Give one example of ‘infrastructure’ referred to in ISO 9001:2015 clause 7.1.3 and describe how it could affect conformity to product requirements.

(2 marks)

Question 1.5

ISO 9001:2015 requires the analysis of data and information.

Give two examples of how analysed data and information is used in an ISO 9001:2015 QMS. For each example quote the relevant ISO 9001:2015 clauses.

(2 marks)

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

Question 2.1

An audit should be evidence-based.

a) In your own words, briefly explain the principle of an ‘evidence-based approach to auditing’.

(3 marks)

Question 2.1

An audit should be evidence-based.

b) Identify two methods by which an auditor gathers evidence.

(2 marks)

Question 2.2

You are the audit team leader conducting the opening meeting of an external audit. The Managing Director is very insistent that your audit team start the audit by watching a video of the company history, followed by a short tour of the site to give you an understanding of the company.

Outline five issues you should consider before deciding whether or not to go ahead with their suggestion.

(5 marks)

Question 2.3

Outline five items that an audit plan should include.

(5 marks)

Question 2.4

In an audit situation:

a) Briefly describe why it is important to contact the person responsible for an area prior to an audit of that area. (This might be the process owner for an internal audit or the Quality Director/Manager for an external audit).

(2 marks)

Question 2.4

In an audit situation:

b) List three topics you would want to discuss when contacting that person prior to the audit.

(3 marks)

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

Question 3.1

You are conducting an ISO 9001:2015 audit at a component manufacturing company. The next activity on your audit plan is the organisation’s purchasing process.

Outline in a checklist how you will perform this audit by developing a series of ten audit checkpoints. 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

ISO 9001:2015 suggests that: “The extent of documented information for a QMS can differ from one organisation to another”.

a) Outline three benefits to the organisation of an appropriately documented QMS.

(3 marks)

Question 3.2

ISO 9001:2015 suggests that: “The extent of documented information for a QMS can differ from one organisation to another”.

b) Outline three disadvantages of an overly documented system.

(3 marks)

Question 3.2

ISO 9001:2015 suggests that: “The extent of documented information for a QMS can differ from one organisation to another”.

c) ISO 9001:2015 includes specific requirements for the control of ‘documented information of external origin’.

Give two examples of such documents

(2 marks)

AND

State two document control issues that might apply particularly to documents of external origin.

(2 marks)

Question 3.3

You are carrying out an audit interview with the Managing Director. You ask if he has set any quality objectives for the organisation. He replies that he has set three for this year. The first is to increase sales by 10% (volume) within twelve months. The second is for a reduction in reject rates for product X by 20%, over the next six months. The third is to reduce operating costs by 5% within the next twelve months.

Outline five questions you would ask to determine the suitability of these as quality objectives.

(10 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)

Question 4.1 – Audit situation one:

You ask the Business Controls manager for this year’s schedule for internal audits. This shows that the ten departments in the organisation are each audited once every twelve months and that this year’s programme has been completed.

You ask the Business Controls manager how the frequency of audits was decided. She says that when the system was implemented three years ago, internal audits were scheduled at intervals of twelve months. The organisation has kept to the same schedule ever since.

You confirm that all of the scheduled audits for the last three years have been completed and fully reported.

Over the three-year period a total of forty-five nonconformity reports (NCRs) were raised. Of these, twenty-five NCRs were in the Purchasing department and fifteen were in the Inspection department.

The remaining five NCRs were shared between five other departments. Three departments had no NCRs.

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

• Complete the nonconformity report on the following document:  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)

Question 4.2 – Audit situation two:

You are carrying out an audit of an insurance company. You ask the New Business manager what his key process is. He states that it is in an online document called The Guide to Identifying and Dealing with Insurance Risk. The Business manager points to the same document when asked the same question.

During the same audit, you discuss the risk evaluation process with the Business Risk Manager. He describes a comprehensive system based on the Plan-Do-Check-Act cycle for risk, which includes identifying risks, determining the need to take action, implementing actions and ensuring that the actions are successful. This is described in The Guide to Identifying and Dealing with Insurance Risk.

Later, you ask the Chief Executive Officer about The Guide to Identifying and Dealing with Insurance Risk. He tells you that it is not a document he is familiar with. He explains that, as an organisation, risks and control measures are vital to their business.

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

• Complete the nonconformity report on the following document:  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)

Question 4.3 – Audit situation three:

You are auditing the management of nonconformity at a company that provides laboratory services.

You check a recent nonconformity report (number NC 45), which was raised by the Laboratory Manager. It states, “The waste bins that must be emptied on a daily basis had not been emptied the previous night by the cleaning subcontractor”.

You ask how important is it that this is done and the Quality Manager states “It is critical to the operation of the laboratory. Failure to empty the bins causes delays, which result in customer complaints”.

You sample further and find this same problem has occurred four times within the previous six months. Each time a nonconformity report was raised by the laboratory (numbers NC 27, 28, 35 and 38).

Documented information (records) show that each time the nonconformity was raised, the subcontractor apologised and explained that they had to use temporary staff at short notice.

Documented information (records) also shows that the auditee organisation responded only by asking the subcontractor to ensure that their employees, whether temporary or full-time, were made fully aware of the tasks they are contractually obliged to carry out.

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

• Complete the nonconformity report on the following document:  QMS Audit 3

OR

• Complete the audit investigation template.