CASE STUDY #4 - VILT

Identifying Non-Conformities

Time Allowed = 60 minutes

Task

Working in your team in your assigned breakout rooms, discuss and reach agreement as to which clause or sub clause of
ISO 9001:2015 would be applicable should a NCR be raised for each of the scenarios listed below.

If you do not think there is enough evidence to raise a NC, summarise the audit trail you would follow to investigate
further.

Each group will be asked to present some of the answers to the course – ensure you have appointed a Team Leader.

!!! Make sure everyone has the chance to act as the team leader throughout the course.

Scenarios

1) In discussion with the design team the auditor had examined documented results of an FMEA that indicated a number
of potential weaknesses in the product. However, it was not planned to avoid problems occurring – but the
decision left to wait and see fail results after product launch.

Cl- 8.3 Design and Developments of products and services

Sub Cl- 8.3.2 Design and Developments planning

2) There is no evidence that the company has made any effort to identify external and internal issues and the
requirements of any relevant stakeholders.

4.0 context of the Organization

4.1 understanding the organization and its context

3) The organization considers risk-based thinking is inherent in its operations and has not taken any further steps to
address.

6.0 Planning
6.1.1 Action to address risk and opportunities

4) Staff in the design and production departments were not aware of contract change agreed one month earlier on a
current project.

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 8.2.4 Changes to the requirements for product and services

5) The company had identified a list of regulatory and legal requirements but the auditor was unable to find evidence
that this information had been sent to managers.

7.4 communication further investigation

6) Minutes from the management review meeting, which is held every six months, reported that 6 corrective actions
from the internal audit were not yet closed from an internal audit held 5 months earlier.
9.2 Internal audit

7) The measurable quality objectives were not related to the company product

7.1.5 Measuring resources

8) The organization retains QMS documented information as evidence. The auditor cannot establish from
communication with the Quality Manager how this documented information is protected from unintended
alterations
7.1.5 Control of documents information

9) The auditor could not establish that staff had any understanding of their responsibility to achieve quality objectives.

7.2 competency 7.3 b

10) The auditor (while talking to the sales manager) was advised that the audited organization had not carried out any
surveys to establish customer perception of the product. There had also been no customer complaints received for
over a year so a customer survey was considered unnecessary.

9.1.2 Customer satisfaction

11) The auditor could find no documented records that processes continued to meet their specified requirement as
established when first set up.

7.1.5.1 General

12) There was no evidence of the type and extent of control of externally provided of processes, products and services.

8.4 General

13) Inspection records did not indicate the authority responsible for the release of the product.

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 5.3 Organization roles 8.6 b

14) The auditor couldn’t establish from interviewing the quality manager what date is being taken into account when
identifying needs and opportunities for continual improvement.

10 improvements 10.3 and further invetigation

15) Product characteristics were not being measured to provide product verification of the final inspection stage.
8.5.1.c

16) When upgrading the QMS to the new ISO 9001:2015, the company said it was necessary to withdraw all the existing
documented information for 2 months prior to re-issuing new updated documents.
9.2 Internal audit 6.3 b

17) The auditor noted, communications were generally good between staff throughout the organization but could find no
details within the quality system to ensure this occurred.
Further investigation

10.2.1.a

18) The auditor has established that the organization has systematically disregarded customer complaints since the
launch of their new product.
8.2 requirements of product and services

19) The auditor was concerned that information provided by clients was being published without the client expressing
permission.

8.5.3

20) When checking a number of items in a production process, the auditor was unable to tell if the item had been subject
to inspection or not from the accompanying information.

6.2 General8.5.2