Qms Exam Paper 1jan2019 PDF Free [PDF]

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CONFIDENTIAL APPROVED TRAINING PARTNERS CQI and IRCA Examination Paper 1 for Quality Management Systems Auditor Training Courses (PR328 & PR345 ISO 9001) Please write your name and the date in the space below. Name: Date: THESE SPACES ARE FOR OFFICIAL USE ONLY Section

Marker 1

Pass mark

Maximum

1

5

10

2

10

20

3

15

30

4

15

30

Total

63

90

Name of Marker

Marker 2

Confirmed

Result

This examination is closed book.  A clean copy of ISO 9001 and a bilingual dictionary are the only items permitted for reference.  Electronic devices, including laptops and mobile phones, are not permitted into the examination room. Exceptions may be granted to delegates with special needs. Any such arrangement must be with the prior written agreement of the Approved Training Partner and shall include a record of appropriate precautions that will be taken to ensure the fairness and security of the examination process and examination questions.

CQI and IRCA Exam paper QMS 1, September 2018. Amended for use on certified course 1895 operated by Quality Austria Central Asia Pvt. Ltd. (6027922) Page 1 of 33

Information for delegates The examination paper is in four sections. Attempt all sections and all questions. The time allowed is two hours. There is no additional time allowed for reading the examination paper. 90 marks are available. To pass you must achieve at least 63 marks (70%), and you must achieve at least 50% in each of the four sections. The maximum marks for each question, or part of a question, are shown in brackets. Your answers must be written on the sheets supplied. Please avoid writing in the margins; these are for the markers. Write on the reverse side of a page if necessary. Additional loose sheets will not be accepted. All references to ISO 9001 refer to the latest issue. Examination technique Time management is very important in the examination. For guidance, the average time available is: a) Reading the examination instructions – five minutes b) Section one – fifteen minutes c) Section two – twenty minutes d) Section three – forty minutes e) Section four – forty minutes Total time available – two hours (120 minutes) Allow enough time to read each question properly. Make sure you understand what is being asked for before starting to write your answer. Where appropriate, the action verb that indicates the depth of answer required by the question – explain, list, describe – is printed in bold. You should ensure you understand the meaning of these terms (see below). Full marks will not be awarded for a list if an explanation is required. Conversely, it is a waste of time to provide a detailed explanation if the question asks for a list. Action verb

Meaning

describe

depict in words

explain

give a clear account of

outline

give the most important features of (less depth than explain or describe)

briefly

using few words or without giving a lot of details

CQI and IRCA Exam paper QMS 1, September 2018. Amended for use on certified course 1895 operated by Quality Austria Central Asia Pvt. Ltd. (6027922) Page 2 of 33

give

provide without explanation (used normally with the instruction to „give an example (or examples) of ....‟)

list

provide a list without explanation (bullet points)

identify

select and name

define

provide a generally recognised or accepted definition

state prepare

a less demanding form of „define‟ or where there is no generally recognised definition make (something) ready for use or consideration

support

strengthen, substantiate, back up, give weight to

CQI and IRCA Exam paper QMS 1, September 2018. Amended for use on certified course 1895 operated by Quality Austria Central Asia Pvt. Ltd. (6027922) Page 3 of 33

Section one – Five questions worth two marks each – maximum 10 marks 1.1

ISO 9001:2015 requires that „personnel...shall be competent‟. Explain, in your own words, what „competent‟ means. (2 marks)

1.2

Explain, in your own words, the terms „audit scope‟ and „audit criteria‟ and give an example of each. (2 marks)

CQI and IRCA Exam paper QMS 1, September 2018. Amended for use on certified course 1895 operated by Quality Austria Central Asia Pvt. Ltd. (6027922) Page 4 of 33

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 organisation‟. Explain, in your own words, what is meant by this phrase. (2 marks)

1.4

State four clauses of ISO 9001:2015 that relate to top management responsibilities or activities. (2 marks)

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1.5

Explain, in your own words, the difference between „design verification‟ and „design validation‟. (2 marks)

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Section two – four questions worth five marks each – maximum 20 marks 2.1

In your own words and using examples as appropriate, briefly explain the difference between „monitoring‟, „measuring‟ and „measuring equipment‟. (5 marks)

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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)

CQI and IRCA Exam paper QMS 1, September 2018. Amended for use on certified course 1895 operated by Quality Austria Central Asia Pvt. Ltd. (6027922) Page 8 of 33

2.3

In an audit situation: a) Give one example of documented information for audit an auditor would prepare before an audit. (1 mark)

b) Briefly describe how an auditor would use it during the audit. Include at least four uses in your description. (4 marks)

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2.4

List three subjects to include in a closing meeting and briefly describe the purpose of each. (5 marks)

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

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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)

b) Outline three disadvantages of an overly documented system. (3 marks)

CQI and IRCA Exam paper QMS 1, September 2018. Amended for use on certified course 1895 operated by Quality Austria Central Asia Pvt. Ltd. (6027922) Page 14 of 33

c) ISO 9001:2015 includes specific requirements „documented information of external origin‟.

for

the

control

of

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)

CQI and IRCA Exam paper QMS 1, September 2018. Amended for use on certified course 1895 operated by Quality Austria Central Asia Pvt. Ltd. (6027922) Page 15 of 33

3.3

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)

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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)

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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)

CQI and IRCA Exam paper QMS 1, September 2018. Amended for use on certified course 1895 operated by Quality Austria Central Asia Pvt. Ltd. (6027922) Page 18 of 33

4.1 – Audit situation one: 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 page.

Or 

Complete the audit investigation template.

CQI and IRCA Exam paper QMS 1, September 2018. Amended for use on certified course 1895 operated by Quality Austria Central Asia Pvt. Ltd. (6027922) Page 19 of 33

QMS AUDIT - NONCONFORMITY REPORT 1 For correctly identifying the scenario as a nonconformity (2 marks) Description of the nonconformity (Max 3 marks):

Relevant evidence (Max 3 Marks):

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ISO 9001:2015 clause and requirement:

Note: 1 mark for clause and requirement plus 1 mark for clarity of answer OR Complete your answer on the following page.

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QMS AUDIT - AUDIT INVESTIGATION 1 Reason why there is not yet sufficient evidence for reporting nonconformity (Max 2 marks):

Four audit trails you would follow, including, evidence sought and purpose. (Max 2 marks for each audit trail):

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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 page.

Or 

Complete the audit investigation template.

CQI and IRCA Exam paper QMS 1, September 2018. Amended for use on certified course 1895 operated by Quality Austria Central Asia Pvt. Ltd. (6027922) Page 24 of 33

QMS AUDIT - NONCONFORMITY REPORT 2 For correctly identifying the scenario as a nonconformity (2 marks) Description of the nonconformity (Max 3 marks):

Relevant evidence (Max 3 Marks):

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ISO 9001:2015 clause and requirement:

Note: 1 mark for clause and requirement plus 1 mark for clarity of answer OR Complete your answer on the following page.

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QMS AUDIT - AUDIT INVESTIGATION 2 Reason why there is not yet sufficient evidence for reporting nonconformity (Max 2 marks):

Four audit trails you would follow, including, evidence sought and purpose. (Max 2 marks for each audit trail):

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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 page.

Or



Complete the audit investigation template.

CQI and IRCA Exam paper QMS 1, September 2018. Amended for use on certified course 1895 operated by Quality Austria Central Asia Pvt. Ltd. (6027922) Page 29 of 33

QMS AUDIT - NONCONFORMITY REPORT 3 For correctly identifying the scenario as a nonconformity (2 marks) Description of the nonconformity (Max 3 marks):

Relevant evidence (Max 3 Marks):

CQI and IRCA Exam paper QMS 1, September 2018. Amended for use on certified course 1895 operated by Quality Austria Central Asia Pvt. Ltd. (6027922) Page 30 of 33

ISO 9001:2015 clause and requirement:

Note: 1 mark for clause and requirement plus 1 mark for clarity of answer OR Complete your answer on the following page.

CQI and IRCA Exam paper QMS 1, September 2018. Amended for use on certified course 1895 operated by Quality Austria Central Asia Pvt. Ltd. (6027922) Page 31 of 33

QMS AUDIT - AUDIT INVESTIGATION 3 Reason why there is not yet sufficient evidence for reporting nonconformity (Max 2 marks):

Four audit trails you would follow, including, evidence sought and purpose. (Max 2 marks for each audit trail):

CQI and IRCA Exam paper QMS 1, September 2018. Amended for use on certified course 1895 operated by Quality Austria Central Asia Pvt. Ltd. (6027922) Page 32 of 33

THIS IS THE END OF THE EXAMINATION PAPER

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