Exercise – NC Management

NONCONFORMITY REPORTS

Purpose of the Exercise

The purpose of this exercise is to develop the ability to assess the available information and determine
whether there is sufficient evidence of conformance or evidence to issue a nonconformity;

Nonconformity Reports

The following are description of incidents observed by an auditor during the course of an audit.

They contain description of situations where nonconformity report may be required. The students should
read the descriptions of all incidents with the team and then required to examine carefully the incidents
whether there is a nonconformity or not:

a) If you think that there is sufficient objective evidence of Not a nonconformity then you should
write your justification with the next course of action.

b) If you think that there is sufficient objective evidence of nonconformity then you should state
the applicable clause, grading (minor/major), standard requirement and objective evidences.

Note: The participants are instructed to complete only the TOP (In case of a nonconformity) or the
BOTTOM (where there is no nonconformity) of each form.

The reports should then be prepared using NCR forms at the end of this handout.

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 Exercise – NC Management

Incident 1

In the Quality Manager’s office the auditor reviewed a number of internal audit
and manufacturing process audit reports. The auditor noted that in all audit
rounds for the past two years, some 70% of non-conformities were noted in the
heat treating department. The procedure for internal audits required auditing all
departments at six month intervals and this was followed strictly ever since
implementation of the system.

Incident 2

While auditing the sales marketing/order entry process of a tire manufacturer,

the auditor interviewed 6 out of the 20 people working in the process. The
auditor previously reviewed the process objectives, which included:

1. All orders reviewed and processed within 2 days of receipt from the
customer.
2. Overall 98% on time delivery to customer promise date.
3. Actual production within 2 % of quoted production time.

The six people interviewed all shared a different approach to processing and
reviewing an order received from the customer. When the auditor asked if there
were any instructions or procedures that defined the execution of the process,
the process owner stated that there was not any such document since the
standard did not require one. All people interviewed were aware of the status
towards the objectives which were not being met or showing positive trends,

orders reviewed was at an average of 6.2 days and getting worse, on time
delivery was holding steady the last several months at 88% and production time
to quote was at 11 %.

Incident 3

Before an audit in the Design Department in XYZ, Inc., 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 for Customers ABC
Project # 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. The Design HOD explained that every design was unique and the
requirement for design validation was not applicable to the products they were
designing.

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 Exercise – NC Management
Incident 4

An auditor is trying to verify if there is a process in place to motivate employees

to achieve the company quality objectives. When the President and owner of
the company was asked how the process worked he stated, “They are lucky to
have jobs! That is their motivation.” The auditor then asked 20 of the 30
employees on the production line what their motivation was to achieve the
quality objectives. Every employee stated that the goals to increase
productivity by 50% and reduce scrap by 25% were impossible to achieve since
they were already working too much overtime, the production equipment was
old and rarely made it through a shift without breaking down and there were no
plans laid out on how to actually achieve the goals.

Incident 5

Calibration Plan indicate that Equipment PRT104 used in Assembly area, was
due for calibration for the last one month. No evidence of calibration available
for the above equipment.

Procedure CPR24 for maintenance of equipements requires timely calibration of

all equipments as plan.

Incident 6

Supplier ‘M/S Surya Products’ have been rated as ‘C’ in the monthly rating
consistently for the last 6 months asking him to improve performance.

Controls exercised on supplier have not been changed over a period of six
months, though the requirement as per procedure CPR28 is to base the type and
extend of controls exercised on the supplier on the past experience. Where
applicable.

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 Exercise – NC Management

Incident Number:
Process / Area: ISO 9001:2015 Clause Number:
Finding: MAJOR / MINOR
NC Statement:

Evidence:

Impact of Finding (check all that apply): Performance Risk Variation

Waste
Explanation of Impact:

ISO 9001:2015 Requirement:

If you do not think that there is sufficient evidence of nonconformity, state the
reason(s) for your decision and state also what further actions (or audit trails) the
auditor should take.

Reason(s):

Further Audit Trails:

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Internal & 2 Party Auditor Training, ISO 9001:2015:2015
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 Exercise – NC Management

Incident Number:
Process / Area: ISO 9001:2015 Clause Number:
Finding: MAJOR / MINOR
NC Statement:

Evidence:

Impact of Finding (check all that apply): Performance Risk Variation

Waste
Explanation of Impact:

ISO 9001:2015 Requirement:

If you do not think that there is sufficient evidence of nonconformity, state the
reason(s) for your decision and state also what further actions (or audit trails) the
auditor should take.

Reason(s):

Further Audit Trails:

Incident Number:
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Internal & 2 Party Auditor Training, ISO 9001:2015:2015
; Feb’2017, Rev.00