Assignment-2

03 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)

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 Assignment-2

4.1 – Audit situation one:

In the final inspection and despatch area you are examining the inspection and
despatch records for order number 1234. This relates to product XYZ that is due to
be sent out 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 Despatch Supervisor tells you that JW is one
of the junior inspectors.

You ask the supervisor: ‘Who has authorised the release of the product?’ The
supervisor replies that authorisation is not necessary for this type of routine product
and it is clear from the records that the inspection was satisfactory. He says: ‘If
there has been any problem we get a signature from David Manvers, the Chief
Inspector, but only if they had to do some rework to the product.’

You check the organisation’s documented information for the product release
process and find it states that the Chief Inspector is responsible for authorising 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.

Or

 Complete the audit investigation template.

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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 design and development process in an organisation that designs
and manufactures industrial equipment.

They are currently dealing with 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 find a recent note on file that states that the engineers are currently having
difficulty in repairing the equipment. They have been issued with the latest drawings
for the equipment (serial number X134, revision 3). The drawings do not contain a
modification to the safety mechanism that was made prior to delivery and installation
of the equipment.

You confirm with the Design Manager that revision 3 is the current version of the
drawings and that revision 3 does not include the change to the safety mechanism.
You ask the Design Manager why the modification to safety mechanism was not made
to the drawing and he replies that the change was reviewed and considered to be
minor with no impact on the equipment and it didn’t affect the customer’s contract
specification.

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.

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 Assignment-2

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:

During an audit of an insurance company, you ask the Training 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 Training Manager how they evaluated the training and are told “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. All three awarded high marks on how enjoyable they found
the course and the usefulness of the course. All three also awarded a satisfactory
score for the tutor.

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.

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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):

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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 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):

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