Exercise : Audit Case studies Date:

Name of the Participant : Name of the organization :

Note : Identify non-conformity in following scenarios & corresponding clause No.

NC ISO
SN Scenario Y/N Cl. No.
Records of approval of Supplier M/S QualiTech, supplying very important
raw material which may affect final product quality, were not available in
purchase section. Purchase in-charge informed that the supplier is well
1.
established for years and is rather only source in the country, thus
evaluation was not carried out. Risk assessment of this supplier was also
not available
When the auditor enquired about determination of external and internal
issues that are relevant to its strategic direction, Marketing and Product
development process owners in an engineering organization gave two
2. different replies. When it was asked whether the information about the said
issues is documented, monitored and reviewed both were unanimous that
there was no such requirement defined in their QMS documentation and
they do not have any evidence to demonstrate.
It was observed in an Engineering organization in manufacturing function
that three objectives out of five objectives were not achieved. When the
auditor asked about the reasons thereof the department head replied that
3. they have not determined when it will be completed as well as how the
results will be evaluated and monitored. He claimed that he had utter
clarity about what needs to be done to achieve it as compared to other
HODs.
In an Engineering organization it was observed during audit that
capabilities of and constraints on the existing internal resources;
necessary for meeting the sudden increased demand of the Key OEM
customer CC3 for supplying an important packing material PMXX3 , are
not analysed. They were supplying 300 tonnes per month to CC3 and
4.
suddenly demand stepped up to 700 tonnes per month for CC3.
Marketing has committed to comply with the required delivery schedules
without any discussion with production and QA team. Currently they are
operating at 80 % capacity utilization and established capacity of plant is
1000 tonnes per month.
The customer complaints were monitored in an organization. However the
results of monitoring were neither analysed nor evaluated. When asked
the top management claimed that they were directed to respective
5. departments and they may be retaining documented information about the
results. He further stated that he was confident that the same complaint
has never been repeated by the same customer twice and it was a very
satisfactory situation.

Qualicon Services, Pune email: qualiconshripad@gmail.com Page 1 of 6

 Plant Maintenance departments in a Engineering organisation had not
documented the methodology to address the risks and opportunities wrt
process outcomes. When asked to explain the scenario both stated that
their activities are meticulously monitored and it was discussed and
6.
decided in the earlier MRM and objectives are being constantly monitored.
On time delivery analysis shown 30 % deliveries were not on time due to
unexpected machines breakdowns and time taken to repair due to non
availability of spares.
Temperature controller cum indicator was being used during process
control for controlling the temperature of a hazardous process step. When
the auditor asked for the latest calibration certificate it was brought from
7. QA department. The auditor found that the cal certificate indicated that
equipment was out of calibration. The production supervisor said that it
was not his responsibility to ensure the validity of the calibration and there
was no problem with the process control.
Preventive maintenance schedule is not adhered to for two particular set of
Compressors repeatedly every quarter. Few of the check points were not
completed, and few of the Preventive Maintenance occasions were
skipped. After analysis of the total breakdown of the plant , 60 % downtime
8. of the process is on account of the same Compressor and resulting to
missing on time delivery to customers. Maintenance Engineer said its
because of the repeated absenteeism of the experienced contract
manpower and new person is not able to complete the workload within the
stipulated time.
Design and development Plans does not define the stage for Design
verification. Records shown as evidence for design verification does not
9. verify all design output meet design input requirements. Methodology for
design verification is not defined in design procedure for new product
design and variant of existing product as well as for design change.
Records of the approval of the process parameters in the paint shop were
not available. The production In-charge stated that the parameters for the
10.
process were given by their collaborators and hence no approval is
required
Recently in last quarter, as a part of Kaizen implementation, new material
handling platform and a sizing fixture and few sensors are newly added in
the current Assembly line machine and hence increasing the productivity
of Assembly line by 20 % and reducing the internal rejection due to size
11.
variation by 10 % but auditor could not get any evidence of Process
change management, revised process control documents or production
capacity documentation or Preventive maintenance of sensors of sizing
fixtures.
During a document review, the auditor notes that QD/QC/05,Rev. no. 03,
incoming inspection checklist states that for material xx bending test is to
12. be carried out. When asked the QC inspector about the inspection report
of the same, he replied that bending test is not carried out for last 6
months as the measurement device is under breakdown
Qualicon Services, Pune email: qualiconshripad@gmail.com Page 2 of 6
 Customer has defined acceptance criteria as 61 to 73 for Product
characteristic PCC07 as per PO no. 200122 dated 01/12/2019. At the
final product release point QPoint 12, at 2.00 p.m., auditor picks up
random 5 samples for each lot of 100 ready products, asks the concerned
QC person to verify the reading for Product characteristic PCC07 and later
confirms reading between 72-75 for all 5 samples. After verifying for few
13.
more batches in ready for dispatch condition , auditor confirmed the same
deviation. Auditor asks for Final inspection and test records, and he is
shown lot release records by authorized personnel for all 32 lots but no
evidence is available to demonstrate that the lot met the customer
specified requirements. After verifying it was noted that sixteen lots were
already dispatched till 2 p,m and rest twenty lots were ready for dispatch .
Records shows that Customer has raised more than 10 complaints in last
Quarter on delayed deliveries and damages in transit but organization
14. could not demonstrate the Risk assessment for delivery delays and transit
damages in Risk and opportunity register. Risk register is also not updated
in last one year.
Stores could not achieve their quality objectives of reducing the rejection of
important chemical having shelf life of 3 months, from current 10 % level to
2 % level . After probing auditor could get the action plan for achieving the
quality objectives but could not evidence of its completion as Stores did
not get support of Purchase and maintenance team to do the necessary
modification of racking system for FIFO implementation. When asked for
15.
the reason for not providing needed support, Purchase and maintenance
head said that they are unaware of such support to be provided for
achieving Quality objectives of Stores, They did not have copy of the
action plan and never remember of any such discussion in any meeting.
There is no evidence of review by Stores head for achievement of Quality
objectives.

Qualicon Services, Pune email: qualiconshripad@gmail.com Page 3 of 6

 Audit report No. Sr. No.

Observation: ( What you have observed + Objective Evidence)

Attribution cum Explanation : ( Why its NC)

Audit report No. Sr. No.

Observation: ( What you have observed + Objective Evidence)

Attribution cum Explanation : ( Why its NC)

Qualicon Services, Pune email: qualiconshripad@gmail.com Page 4 of 6

 Audit report No. Sr. No.

Observation: ( What you have observed + Objective Evidence)

Attribution cum Explanation : ( Why its NC)

Audit report No. Sr. No.

Observation: ( What you have observed + Objective Evidence)

Attribution cum Explanation : ( Why its NC)

Qualicon Services, Pune email: qualiconshripad@gmail.com Page 5 of 6

 Audit report No. Sr. No.

Observation: ( What you have observed + Objective Evidence)

Attribution cum Explanation : ( Why its NC)

Audit report No. Sr. No.

Observation: ( What you have observed + Objective Evidence)

Attribution cum Explanation : ( Why its NC)

Qualicon Services, Pune email: qualiconshripad@gmail.com Page 6 of 6