Case Studies of Internal Quality Audit

Case Studies

IDENTIFY THE FOLLOWING FOR THE CASE STUDIES ENCLOSED:

1. Whether Non Conformance or Not

2. Attribution to the clause for the Non Conformance

3. Auditor’s comment on the observed Non Conformance

CASE 1 Department: Production (Production Supervisor)

Auditor: Explain your Quality policy & Objectives?
Auditee: ………..thinks…thinks.
Auditor: Get a copy from MR. Please read & try to understand.

CASE 2 Department: MR
Auditor: How many management review meetings you have conducted?
Auditee: Three management review meetings you have conducted so far.
Auditor: Show me the summery status & minutes of all the meetings.
Auditee: Presents to the auditor.
Auditor: Verifies the minutes of second management review meeting & asks to auditees to
show the action no4, 5,6 review results in 3 rd meeting minutes.
Auditee: No need to cover in the 3rd Management Review Meeting.

CASE 3 Department: Engineering- in drawing room (Engineering Head)

Auditor: Auditor picks a drawing. Is it included in the master list of drawing?

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 Case Studies of Internal Quality Audit

Auditee: Searching in the master list…No it is for development product.

Auditor: How you are identifying the status of various drawings?
Auditee: By part no.
Auditor: Please show me the Quality Planning file?
Auditee: Submits Quality Planning file.
Auditor: Searches & not able to find out for the above case.

CASE 4 Department: Production

Auditor: Does clause, customer supplied property is applicable to you?
Auditee: Thinks…No.
Auditor: Auditor verifies the various sections & its activities in the shop floor.
In servicing department - Why these products are lying here?
Auditee: These are received from customer for servicing.
Auditor: Show me any document, which is explaining about verification & control
throughout the process.
Auditee: Searches… No it is not defined in any procedure.

CASE 5 Department: Production

Auditor: Verifies the copper pipe bending process being carried out by the operator.
Calls another operator, shows him pipe after the bending process & asks is it
accepted?
Operator: No… Not accepted & he explains his views.
Auditor: Asks same question to third operator.
Operator: Yes, it is accepted.
Auditor: Finally Production Supervisor says, “accepted” to the auditor.

CASE 6 Department: Production (in shop floor with operator)

Auditor: Show me document / instruction for this process?
Auditee: Show the process sheet with drawing.
Auditor: Verifies the revision status of the drawing revision against the Master List of
Drawings held by the Design Department.
The Master List shows revision status 04. where as the drawing copy received
from the operator shows revision status 02.

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 Case Studies of Internal Quality Audit

CASE 7 Department: Production (Process – Crimping)

Auditor: Can you show me document / instruction for this process?
Auditee: Shows the work instruction to the auditor.
Auditor: Tell me how, you will ensure the withstanding pressure?
Auditee: Explains the methods.
Auditor: Verifies the work instruction, which is not in line with the statement of the
operator but the auditor feels that the method explained by the operator can also
be applied.

CASE 8 Department: MR
Auditor: Show me the Master List of Document with the latest revision?
Auditee: Shows the master list, which indicates the latest revision.
Auditor: Verifies the Work Instructions held by the Production against the master list. He
ensures that the revision status is same.

CASE 9 Department: Quality (Incoming Quality Section) During Inspection of a

Subcontracted Team.
Auditor: Show me the Inspection Reports of this item XXX.
Auditee: Shows the inspection reports file.
Auditor: Verifies the inspection reports with the Quality Plan. Some of the parameters are
outsides the specification limits but are still accepted.

CASE 10 Department: Quality control

Auditor: What are all the statistical techniques that are identified for the different
application?
Auditee: Explains with the list of the techniques & applications.
Auditor: Show me any document / record with reference to the any one technique.
Auditee: Explains one technique with relevant records.

CASE 11 Department: Quality control

Auditor: Show me the inspection reports of the different stages.

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 Case Studies of Internal Quality Audit

Auditee: Gives the inspection reports of the different stages.

Auditor: Finds deviation in the inspection report & verifies with the non-conformance
register.
Can you show me the where this non-conformance is reflected in the non-
conformance register.
Auditee: No…this is before our system effective date.

CASE 12 Department: Store

Auditor: Verifies the raw material in the store & its condition, storage area. Auditor finds
that the roof is leaking.

CASE 13 Department: Quality Control

Auditor: Verifies the calibration certifications & records.
What is the operating range for the temperature controller?
Auditee: He says 200 – 300 degree.
Where as that is calibrated for the range of 300 – 400 degree.
CASE 14 Department: Quality Control
Auditor: Verifies the out of calibration certifications & records.
Tell me what further actions were taken?
Auditee: Instrument scrapped.

CASE 15 Department: Quality Control

Auditor: Verifies the calibration records.
Auditor finds that the History Card of Adjustable Snap Gauge No. XX/23 says,
“Before calibration NOT OK” & “After calibration found OK”.

CASE 16 Department: Purchase

Auditor: Is there an approved list?
Auditee: Approved Vendor List is presented.
Auditor: Auditor observes that the basic raw material suppliers are marked (*) & there is a
no evidence to substantiate their selection & capability. (*) Indicates that “
existing prior to the existence of the system”.

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 Case Studies of Internal Quality Audit

CASE 17 Department: Quality Assurance

Auditor : How is final inspection carried out ?
Auditee : As per the Quality Plan to Drawing No. XXX.
Auditor : Can you please present the Quality Plan and Drawing.
Observation.
Drawing XXX specifies for Torque test, Frequency Test and Destructive test
which is not incorporated in the Quality Plan.

CASE 18 Department: Production

Auditor : A plating component is questioned for its process.
Auditee : The plating is sub-contracted.
Auditor : Is it identified as a special process ?
Auditee : No, since it is being sub-contracted.
Auditor : Observes that it is not identified in the Quality Manual also.

CASE 19 Department: QA
Auditor : Observes an inspection report with dimension having 4th decimal being
measured by a Micrometer no. 023. Requests the Micrometer for observation.
Auditee : Presents the Micrometer
Auditor : Observes that the Micrometer is capable of measurement to an accuracy of third
decimal place only.

CASE 20 Department: MR
Auditor : Observes that a Non-conformity report was written as follows :
It may be necessary to develop an additional work instruction for the process
….being practiced.

CASE 21 Department: Lab

Auditor : How is the chemical composition of the component X checked for various
percentages ?
Auditee : Presents an IS No. XXX which has no document and data status.
Auditor : Observation.
The standard was supposed to be issued by the Engineering but not so. An
independent copy was being held by the Lab Incharge.

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Case Studies of Internal Quality Audit

CAST STUDY – 22

Department : Product Development Auditor : Materials Incharge

Auditor reviews the PPAP file for the part no: 2654498 for Ford. During the
review Auditor finds the ‘Endurance test’ was conducted at internal laboratory,
which was not qualified.

CASE STUDY – 23

Department : QA Auditor : Sales Incharge

Auditor verifies the method (work instructions) developed by the company on its
own for product testing which was approved by the Manager – QA and issued by
MR.

Auditor : Have you got approval from the customer for the work instructions
developed for testing.

Auditee : Since it is an internal document, the customer approval is not required.

CASE STUDY – 24

Department: Sales Auditor : MR

Auditor: Observing the customer survey reports & records

How frequently the customer satisfaction survey is conducted?

Auditee: My GM will decide as and when required

CASE STUDY – 25

Department : Vendor Development Auditor : QC Incharge

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Case Studies of Internal Quality Audit

Auditor : Have you performed subcontractor development activity for all

subcontractors

Auditee : We have not performed for all subcontractors since some of the
subcontractors are very small and they do not have any resources to
Implement.

CASE STUDY – 26

Department : Stores Auditor : Marketing Incharge

Auditor : Have you checked the condition of product in stock.

Auditee : Yes. Once in 10 days the physical stocks are verified and stock
statements are prepared.

CASE STUDY – 27

Department : Production Auditor : R & D Incharge

Auditor was auditing the milk industries. During the audit a cat was found in the
shop floor. Find the discrepancies.

CASE STUDY – 28

Department : QA Auditor : Sales Incharge

Auditor : What is the criteria for carrying the visual inspection (appearance) at
final stage.

Auditee : As per the representative samples displayed in inspection area.

Auditor : Do you have photographs in addition to representative samples.

Auditee : No. We may keep in future.

CASE STUDY – 29

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Case Studies of Internal Quality Audit

Department : Product Development Auditor : Maintenance Incharge

Auditor was going through the APQP file. He found that the special
characteristics were identified. Subsequently he went through the drawings and
found that a parameter which he identified & found important was not identified
as a special characteristics by the team.

CASE STUDY – 30

Department : Production Auditor : Stores In Charge

Auditor: Observes that Plant Layout is modified as a part of improvement activity.

What are the activities you had carried out after this change?

Auditee: We had verified change as per lay out.

CASE STUDY – 31

Department : Production Auditor: Stores Incharge

Auditor : What is the basis for performing moulding operation.

Auditee (Operator) : As per the established work instructions (No.Wi/PRD/06)

which is available with the GM-Production.

Ajay Akole 01.02.06