Delegate Handout
Workshop 4B –Identification & reporting nonconformity
Bureau Veritas Certification
WORKSHOP No. 4B- Identification and reporting ‘Non Conformity’
Purpose
The purpose of this workshop is to:
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
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Develop the ability to assess the available information to determine if sufficient evidence
of conformance or non-conformance has been gathered;
Develop the ability to identify the missing information and the ways to establish this
information (audit trail);
Develop the ability to prepare correct non-conformance report.
Hand-outs and Material
The following material must be issued to the delegates for this exercise:
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
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Delegate hand-outs
Flip Charts and marker
NCR Form printed on acetate
– 1 for each delegate
– 3 for each group OR
– 3 for each group
Time allocation
Total
Delegates team work:
Feedback and discussions
: 2 ½ hours
: 1 hour
: 1 ½ hour
THE WORKSHOP
The following are descriptions of incidents observed by the auditor during the course of an
external audit.
They contain descriptions of situations where a nonconformity report may be required. The
delegates should read the descriptions of all incidents. The teams are then required to
carefully examine the incidents allocated by the tutor, and then take one of the two following
actions:
a)
If you think that there is sufficient objective evidence of nonconformity then you should complete a
nonconformity report.
b)
If you do not think that there is sufficient objective evidence of nonconformity then you should
state your reasons in the space below the report. You should also state what the auditor should do
next i.e. identify what must be checked before it can be determined whether or not there is any
nonconformance.
The reports should then be prepared using FLIP CHARTS OR acetate forms and markers
issued by the tutor.
The delegates must strictly present their reports in the format as given at the end of
this hand-out in either of the situations as appropriate
Incident 1
Aug 2015
QMS Auditor/ Lead Auditor Training Course (A 17929)
Page 1 of 5
Delegate Handout
Workshop 4B –Identification & reporting nonconformity
Bureau Veritas Certification
The XYZ Ltd. is a service inspection and testing company. In the Food Analysis Laboratory
two operators were not wearing nylon caps, one operator had her laboratory coat undone
and was wearing jewellery. Other three operators were OK. Procedure FAL 002 rev.2
(which is current version) available in area clearly describes, in clause 7, the dress code
which requires that laboratory coats must be buttoned up, nylon caps must be worn and
wearing jewellery is not permitted.
Incident 2
The XYZ Ltd. is manufacturing food products. Whilst conducting an audit in the production
area auditor is observing the reactor unit on the production line number 5 which is in normal
operation. The pressure gauge shows 2.8 bar. The temperature gauge shows 128
centigrade. Flow meter shows 1.2 cum/min. All instruments have valid calibration stickers.
Auditor asks to see Process Specification for this station. The operator shows the current
version of Specification PSC02 that stipulates the following process parameters:
Pressure:
Temperature:
Flow:
2.5  0.1 bar
130  2 centigrade
1.15 – 1.2 cum/min
Auditor asks the operator how often the parameters are checked. The operator explains
that this normally is done every hour and recorded in process chart. Auditor checks the
charts for past few days and notices that the parameters reading are not recorded since last
shift changeover four hours ago. The operator explains that he was busy cleaning the
reactors on another line and did not have time to take readings. Auditor previously
reviewed the procedure PP16 that indeed required checking and recording the process
parameters every hour. Further investigation showed that the whole batch produced on
that shift did not meet the requirements.
Incident 3
In the Quality Manager’s office auditor reviewed a number of internal audit reports. Auditor
noted that regularly in all audit rounds for past two years around 70% of nonconformances
were noted in the design department. The procedures required auditing all departments at
six monthly intervals and this was followed strictly ever since implementation of the system.
Incident 4
In the production hall auditor noticed two weighing machines. Weighing machine serial no.
1624 had an affixed label stating due date for calibration which was over 4 months ago.
Weighing machine serial no. 1636 had no calibration label attached.
Incident 5
During the audit in the Design Department in XYZ Ltd. the auditor reviewed the Design and
Development Manual and noticed that it did not contain procedures for design validation.
During the audit the auditor reviewed the documentation pertinent to a selection of ten
completed projects # 99/007, 99/010, 99/020, 99/025, 99/031, 99/042, 99/051, 99/054,
99/062 and 99/070 and was unable to find any records of design validation activity. Design
Aug 2015
QMS Auditor/ Lead Auditor Training Course (A 17929)
Page 2 of 5
Delegate Handout
Workshop 4B –Identification & reporting nonconformity
Bureau Veritas Certification
Director explained that as every design was unique and one off the requirement for design
validation was not applicable to the products they were designing.
Incident 6
In the design department auditor reviewed the list of five-quality objective for that
department. Auditor asked if the results of planning that was carried out to achieve these
objectives were documented. The design director replied that any such document was not
prepared, as he believed that it would suppress the creativity.
Incident 7
In the material stores auditor noticed that there were no tags or stickers to show the
inspection status of the materials. Auditor previously visited the assembly line and noticed
that tags or stickers were being used to identify the inspection status. The storekeeper
explained that there was no need to use stickers or tags as all incoming material was kept
in the receiving area until verified and accepted. Only accepted material was being allowed
into designated areas.
Incident 8
In the Quality Manager’s office the auditor reviews the internal audit reports and notes the
following:
Report 03 shows two corrective actions outstanding
Report 05 shows one corrective action outstanding
Report 07 shows one corrective action outstanding
There is no evidence of follow-up action.
(due ten months ago)
(due six months ago)
(due four month ago)
Incident 9
The hospital, XYZ plc, operates emergency ambulance services. Whilst auditing the
Ambulance Department the auditor asked if there were any documented procedures or
instructions for paramedics covering first aid, resuscitation, etc. The head of the
department explained that as all paramedics are highly competent there was no need to
have any such instructions in writing.
Incident 10
XYZ plc manufactures various cosmetics. In the despatch area the auditor was reviewing
the products released for shipment and noticed that the quantity of anti-wrinkle night cream
“Gloria” (Production Order Number 99/6802) which was kept on three pallets and was marked
‘ready for shipment’, did not have the following marked on the boxes:
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
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Batch number.
Production date.
Expiry date.
Procedure FP 001, clause 7.8 requires that the above-mentioned information must be printed
on the boxes for all creams and lotions
Aug 2015
QMS Auditor/ Lead Auditor Training Course (A 17929)
Page 3 of 5
Delegate Handout
Workshop 4B –Identification & reporting nonconformity
Bureau Veritas Certification
If you think there is sufficient evidence to report your findings as a nonconformity, complete the
following nonconformity report.
Incident Number......
NONCONFORMITY REPORT
Description of the nonconformity:
Objective Evidence
ISO 9001:2015 clause and requirement:
OR
Aug 2015
QMS Auditor/ Lead Auditor Training Course (A 17929)
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Delegate Handout
Workshop 4B –Identification & reporting nonconformity
Bureau Veritas Certification
Give your reason(s) for thinking there is not yet sufficient evidence to report your findings as a
nonconformity.
Describe how you would investigate further to determine conformity or nonconformity. Include
audit trails you would follow and specific examples of audit evidence you would seek and for
what purpose.
Incident Number......
Audit investigation template:
Reason why there is not yet sufficient evidence for reporting nonconformity
Audit trails you would follow, including, evidence sought and purpose
Aug 2015
QMS Auditor/ Lead Auditor Training Course (A 17929)
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