CQI and IRCA Examination Paper 1 for Quality Management Systems Auditor Training Courses (PR328 & PR345 ISO 9001)

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

Question 1.1

Explain, in your own words, the difference between an ’audit programme’ and an ‘audit plan’

(2 marks)

Question 1.2

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 1.3

In your own words, explain the terms ‘audit criteria’ and ‘audit objectives’ and give one example of each.

(2 marks)

Question 1.4

State four clauses of ISO 9001:2015 that relate to top management responsibilities or activities.

(2 marks)

Question 1.5

ISO 9001:2015 clause 4.3 states that “Conformity to this International Standard may only be claimed if the requirements determined as not being applicable, do not affect the organisation’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.”

Give an example of where it is acceptable for a requirement to be “not applicable” and, in your own words, the circumstances under which this could be justified. Where must this be stated?

(2 marks)

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

Question 2.1

In your own words and using examples as appropriate, briefly explain the difference between ‘monitoring’, ‘measuring’ and ‘measuring equipment’.

(5 marks)

Question 2.2

In an audit:

a) Describe the purpose of the ‘opening meeting’.

(2 marks)

Question 2.2

In an audit:

b) List three items that should be considered in an opening meeting.

(3 marks)

Question 2.3

In an audit situation:

a) Give one example of documented information for audit an auditor would prepare before an audit.

(1 mark)

Question 2.3

In an audit situation:

b) Briefly describe how an auditor would use it during the audit. Include at least four uses in your description.

(4 marks)

Question 2.4

List three subjects to include in a closing meeting and briefly describe the purpose of each.

(5 marks)

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

Question 3.1

A road haulage company’s quality policy statement states: “We will meet our customer requirements 100% of the time, every time.”

The performance data shows that they have averaged 90% on-time delivery for the previous three years. You discuss this with the Quality Manager who tells you that this is the industry average and they are satisfied with this performance. He explains that “most of the delivery problems are caused by road congestion, and so we do not take any action on late deliveries because this is out of our control”.

You ask to see the records to determine what percentage of the late deliveries is due to road congestion. The Quality Manager states: “We do not keep detailed records because we just know the reasons and have concluded that at the moment we do not need to do anything.”

You ask whether they receive any complaints about the late deliveries. The Quality Manager replies: “On occasion some customers complain but I’m sure most of them understand that the traffic problems are out of our control.”

a) Outline two significant areas of potential concern in the audit situation.

(3 marks per issue = 6 marks)

AND

b) For each issue give two questions you would ask to investigate your initial concerns. For each question identify and quote the applicable clause of ISO 9001:2015.

(1 mark per question per issue = 4 marks)

Question 3.2

You are conducting a third party, ISO 9001:2015 audit of a food processing company’s internal audit process. You determine that the organisation’s internal audit programme has been the same for the past four years. Each department is audited once every year and audit objectives have been limited to checking that work activities are carried out as described in documented procedures.

a) There are two requirements of ISO 9001:2015 clause 9.2 that most likely are not being met, based on what you have determined so far. Outline these two requirements and the relevant clause identifiers.

(4 marks)

Question 3.2

You are conducting a third party, ISO 9001:2015 audit of a food processing company’s internal audit process. You determine that the organisation’s internal audit programme has been the same for the past four years. Each department is audited once every year and audit objectives have been limited to checking that work activities are carried out as described in documented procedures.

b) List three topics that you would want to discuss with the Audit Programme Manager during your audit. For each topic briefly outline what you would want to discuss and why. State the applicable clauses of ISO 9001:2015 as appropriate.

(6 marks)

Question 3.3

You are auditing an organisation’s improvement process. You are seeking evidence of a planned and systematic approach to improvement in accordance with the requirements of ISO 9001:2015.

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 clause.

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)

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.

Delegates 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 the design activities at a company that designs storage and distribution solutions as a service to customers.

You discuss a recently completed project number Q456 with the Project Manager and are shown the customer specification, customer communication and much more documented information (records) leading through to the final Capacity and Operations Planning Recommendations, which is the deliverable from their design and development process.

You ask to see the design plan for the project and the Project Manager tells you: “We do not use design plans as such in this organisation.” You ask: “How do you plan and control the design to ensure everything comes out OK?’” The Project Manager replies that they simply follow their detailed software-based project management process as well as investing a lot of care and attention to ensure the desired solution is achieved.

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

• Complete the nonconformity report on the following:  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.

Delegates 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 auditing a company that manufactures and sells kitchen equipment. You notice that the company documented information (records) show a very large number of customer returns due to malfunction and breakage. This situation appears to have continued for several years. 

 You ask the Quality Manager about this, and he says the company is aware of the matter. You ask if these products are inspected before being dispatched.

 The Quality Manager tells you that any obviously damaged items are removed by the packaging staff before being dispatched, but the small profit margin makes it uneconomic to implement a formal inspection process.

 You ask what action is taken when these products are returned. The Quality Manager explains that most of these returns are stock items of relatively low value. Therefore, it has been decided that it is easier and more convenient to simply replace returned items than it is to investigate and implement a solution.

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

• Complete the nonconformity report on the following:  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.

Delegates 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:

You are auditing an electronic component manufacturer. They have a process for dealing with customer complaints that require them to investigate and take corrective action.

Documented information (records) show that several customers have recently complained about faulty components being delivered. The customers returned the faulty components to the organisation. The organisation then repaired them and returned them back to their customers.

Documented information (records) show that an investigation report found the cause to be that two new employees were undergoing training and had been assigned to tasks where they should have been supervised. Due to staff shortages however, no supervision was provided.

Following the investigation, records show their training had been completed and the employees were assessed as being competent.

There was no evidence of any further investigation or corrective action being carried out and the report had been closed.

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

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

OR

• Complete the audit investigation template.