IRCA QMS Exam Paper Specimen2012

CONFIDENTIAL TO IRCA APPROVED TRAINING ORGANIZATIONS

Examination Paper QMS Specimen Paper for IRCA Quality Management Management Systems Auditor/Lead Auditor Training Courses (IRCA/2245) 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

63

90

Total 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 students with special needs. Any such arrangement must be with the prior written agreement of the IRCA Approved Training Organization 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.

IRCA/146 QMS Specimen/12/1, Jan. 2012 IRCA examination paper QMS Specimen Paper, amended for use on certified course A17086operated by Robere & Associates

Information for students 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. There is a maximum of 90 marks available; the pass mark is 70% (63 marks) and you must also 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 that are 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) b) c) d) e)

Reading the examination instructions – five minutes Section one – fifteen minutes Section two – twenty minutes Section three – forty minutes Section four – forty minutes

Total time available – two hours (120 minutes) Students should allow enough time to read each question properly, and make sure they understand what is being asked, before starting to write the answer. Where appropriate, the action verb that indicates the depth of answer required by the question – explain, list, describe – is printed in bold. bold. Students should ensure they 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 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)

give

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

list

provide a list without explanation explanation (bullet point)

identify

select and name

define

provide a generally generally recognized or accepted definition

state

a less demanding form of „define‟ or where there is no generally recognized definition


Section one

Five questions worth two marks each

–

1. a) State who uses ISO 17021 and for what purpose. (1 mark)

b) Identify the most significant difference between ISO 17021 and ISO 19011. (1 mark)

2. Explain, in the context of auditing, the difference between being argumentative and being assertive. (2 marks)


3. List two ISO 9001 clauses (number and title) that support the quality management principle of a „systems approach‟. (2 marks)

4. Clause 7.3.5 of ISO 9001 requires design verification to be carried out. List two verification activities that may be used by the design function of an organization. (2 marks)

5. Identifytwo ways in which an auditor can verify that agreed corrective actions have been effectively implemented. (2 marks)


Section two

–

Four questions worth five marks each

1. In your own words, briefly explain the plan, do, check, act cycle in the context of an ISO9001 quality management system. Stateone relevant clause of ISO 9001 for each part of the cycle. (5 marks)

2. a) Describebriefly a method you could use to evaluate top management commitment. (2 marks)

b) Give three examples of audit evidence you would gather as part of your evaluation. (3 marks)


3.

A positive auditor attribute is to be diplomatic. a) State the meaning of „diplomatic‟ and give an example to demonstrate how an auditor could be diplomatic. (3 marks)

b) Describebriefly the effect that not being diplomatic could have on an audit. (2 marks)


4. At the opening meeting of a Stage Two certification audit, the management representative of the auditee organization informs the auditor that a recent customer (second-party) audit has found many nonconformities related to the purchasing department. Corrective action has been planned.The management representative suggests that to audit this department again would add no value and asks if you could delete this from the plan and spend more time in the production area. Outline the issues you would include in the response you would give to this request. (5 marks)


Section three 1.

–

Three questions worth ten marks each

During a routine surveillance visit, the organization you are auditing informs you that they no longer carry out any design work. This activity is now outsourced to a subcontractor. Givefour examples of audit evidence you would look for to determine conformance with ISO 9001 and identify the clauses of ISO9001 that relate to this situation. (2 marks for each example and 0.5 mark for identifying the clause of ISO 9001 relevant to each of the four examples = total 10 marks)


2.

Taking into account the requirements of ISO 9001 clause 8.5.2,describe or illustrate using a diagram the corrective action process starting from a nonconformity being raised by an auditor through to close out of the finding. Identify who is responsible for each element of the process and identify where in the corrective action process decisions are taken. (10 marks)


3.

You are planning to audit the testing laboratory of a small injection moulding company. Describe how you would apply a process approach to auditing the laboratory. Your answer should identify four distinct areas of investigation. (2 marks) For each distinct area of investigation,outline the associated audit evidence you would expect to find to demonstrate that the activities of the testing laboratory are conforming to the relevant clauses of ISO 9001 and statethe applicable clause(s) of ISO 9001. (8 marks) You may use text and/or diagrams to explainyour approach.


Section four

Three questions worth ten marks each

–

Instructions to students: 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. You are also required to demonstrate your ability to write a well constructed nonconformity statementthat clearly describes the weakness or failure of the management system, the audit evidence and the requirement(s) of the standard. Three audit situations are described. For each, you are required to determine if there is sufficient evidence to report your findings as a nonconformity with the audit criteria, ISO 9001 (current issue). 

Where you determine there is sufficient evidence you should complete the nonconformity report. To gain full marks you must write a well constructed nonconformity statement that describes clearly the weakness or failure of the management system, the audit evidence and the requirement(s) of the standard.

OR 

Give your reason(s) for thinking there is not yet sufficient evidence to report your findings as a nonconformity and describe the investigation you would follow to determine conformity or nonconformity. Give details of audit trails you would follow, state what audit evidence you would seek and for what purpose, quoting relevant ISO 9001 clause numbers. To gain full marks you must demonstrate understanding of the issue(s) in the audit situation and your ability to investigate and collect relevant audit evidence. Audit trails and audit evidence must relate clearly to the audit situation and be sufficiently comprehensive to enable conformity or nonconformity to be determined.


Audit situation one: In the final inspection and despatch area, you are interviewing the Packing and Despatch Supervisor and examining the inspection and despatch records for order number 1234, relating to product XYZ that is due to be despatched to a customer. You note that in the final inspection section of the records the word „OK‟ is written with the initials JW alongside it. The supervisor tells you that JW is one of the inspectors. You ask the supervisor: „Who has authorized the release of the product?‟ The supervisor replies that this is not necessary for this type of routine product and it is clear from the records that the inspection was satisfactory. He says: „We only get a signature from the Chief Inspector if there has been a problem during production and they had to do some rectification to the product.‟ You check the organization‟ s documented procedures and find they state that the Chief Inspector is responsible for the final release of all products. If you think there is sufficient evidence to report your findings as a nonconformity: 

Complete the nonconformity report on the following page.


IRCA QMS AUDIT - NONCONFORMITY REPORT

ISO 9001:2008 clause and requirement:

OR 

Complete your answer on the following page.


Audit situation one: 

Give your reason(s) for thinking there is not yet sufficient evidence to report your findings as a nonconformity and describe the investigation you would follow to determine conformity or nonconformity. Give details of audit trails you would follow, state what audit evidence you would seek and for what purpose, quoting relevant ISO 9001 clause numbers.

Audit investigation:

THIS IS THE END OF AUDIT SITUATION ONE IRCA/146 QMS Specimen/12/1, Jan. 2012 IRCA examination paper QMS Specimen Paper, amended for use on certified course A17086operated by Robere & Associates

Audit situation two: You are auditing the design process in an organization that designs and manufactures industrial equipment. You find that they are currently addressing a serious customer complaint relating to faulty safety mechanisms. They have sent engineers to this customer to repair some equipment they designed, manufactured and supplied two years earlier for contract number A123. You decide to use this contract to assess the effective implementation of the design process. You find a recent note on file that states that the engineers are currently having difficulty in repairing the equipment because the design drawings they are using (serial number X134, revision 3), which were issued with the equipment, do not show changes to the electronic safety mechanisms that were made prior to delivery and installation of the equipment. You review the design records with the Design Manager and confirm that revision 3 is the final version of the drawings and it does not include the changes to the safety mechanisms. You ask the Design Manager why they were not recorded and he replies that it was not really necessary as the changes were minor and it didn‟t affect the customer‟s contract specification. If you think there is sufficient evidence to report your findings as a nonconformity: 





OR 

Complete your answer on the following page


Audit situation two: 

Give your reason(s) for thinking there is not yet sufficient evidence to report your findings as a nonconformity and describe the investigation you would follow to determine conformity or nonconformity. Give details of audit trails you would follow, state what audit evidence you would seek and for what purpose, quoting relevant ISO 9001 clause numbers.


THIS IS THE END OF AUDIT SITUATION TWO


Audit situation three: During an audit of an insurance company, you ask the Personnel Manager to show you the training records for three people who work in the Claims Department. You see from the training records that each has attended a course on customer care. You ask the Personnel Manager how they evaluate the training. The Personnel Manager replies, “We ask every person who attends a training course to complete a questionnaire on whether they enjoyed the course, how useful they found the training and how good the tutor was. This information helps us decide whether to send other staff on the course”. You examine the questionnaires completed by the three people who attended the customer care course and note that all three awarded high marks on how enjoyable they found the course, the usefulness of the course and a satisfactory score for the tutor. If you think there is sufficient evidence to report your findings as a nonconformity: 





OR 

Complete your answer on the following page


Audit situation three: Give your reason(s) for thinking there is not yet sufficient evidence to report your findings as a nonconformity and describe the investigation you would follow to determine conformity or nonconformity. Give details of audit trails you would follow, state what audit evidence you would seek and for what purpose, quoting relevant ISO 9001 clause numbers.


THIS IS THE END OF AUDIT SITUATION THREE IRCA/146 QMS Specimen/12/1, Jan. 2012 IRCA examination paper QMS Specimen Paper, amended for use on certified course A17086operated by Robere & Associates

--THIS IS THE END OF THE EXAMINATION PAPER--


IRCA QMS Exam Paper Specimen2012

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