SYND EX 5: AUDIT FINDINGS AND CORRECTIVE ACTION REQUEST

Objective evidence
Objective evidence refers to factual information that can be verified or measured, typically
obtained through observation, measurement, or other means of data collection.
Audit evidence
Audit evidence includes both objective evidence (factual information) and subjective
evidence (observations, opinions, interpretations) obtained through interviews,
examination of records, observations of activities, and other audit techniques.
Refer: ISO 9001:2015 (ii) Course Notes - Chapter 5

SOME UNDERSTANDING OF ISO CLAUSES: MUST READ

8.1 Operational planning and control
Planning Processes- identify resources, and methods, establish processes>this done
to ensure product/services requirements are met effectively.
Example: A manufacturing company plans its production activities for the upcoming
month by determining the production schedule, allocating resources (such as manpower
and machinery), and scheduling maintenance activities to minimize downtime.
Customer Requirements>understanding customer needs, specifications, and any
applicable regulatory requirements.
A software development company gathers requirements from its clients for a new mobile
application, including features, performance expectations, and user interface preferences.
These requirements are then incorporated into the development plan.
Risk Management
Example: A construction company conducts a risk assessment before starting a new
project to identify potential hazards, such as adverse weather conditions, supply chain
disruptions, or safety risks. Mitigation measures, such as contingency plans and safety
protocols, are developed to address identified risks
Resource Allocation:
Organizations must allocate resources, including personnel, infrastructure, and materials,
effectively to support their operational activities and meet product requirements.
Control of Processes
This involves defining criteria for process performance, monitoring process outputs, and taking
corrective actions when necessary.
Example: A food manufacturing company implements process controls, such as temperature
monitoring and sanitation procedures, to ensure food safety and quality throughout the
production process. Regular inspections and audits are conducted to verify compliance with
established controls.
Change Management
Organizations must have processes in place to manage changes to their operational
activities, including changes to products, processes, or organizational structure
Example: An automotive manufacturer implements a change management process to
introduce a new manufacturing technology on the production line. This process includes
evaluating the impact of the change, training personnel on new procedures, and
monitoring performance after implementation
Identify/cite objective evidence (or the lack of it) And correctly determine whether the
case conforms with or deviate from the ISO 9001 requirements.
Standard statement to use:
There is no nonconformity yet and further investigation is needed on corrective action -----

CORRECTIVE ACTION REQUEST FORM

DESCRIPTION ISO 9001
CASE NO OF NON- AUDIT EVIDENCE CLAUSE NO.
CONFORMITY AND
REQUIREMENTS
1.In an It is not a non- Assign the
adequacy audit, conformity as responsibilities
the organization per ISO and authorities
chart for standards. for these
Company A It is an processes;
showed that the ‘opportunity for (4.1)
Quality improvement’.
Assurance Advised to
Manager amend the
reports to the organogram to
Production reflect the
Manager. change of
{ An adequacy reporting.
audit focuses on
assessing
whether internal Quality
controls and Manager may
policies are directly report
sufficient and
appropriately to the
designed to Accountable
achieve Manager(CEO)
objectives. On the
other hand, a
compliance audit
verifies if the
company adheres
to external laws,
regulations}
2. The Quality It is a major non- 6.1.1 When
system conformity as planning for the
documentation per ISO standard quality
for Company B 6.1.1 management
showed no Failure in the system, the
evidence of system: organization shall
procedure for QMS is not consider the
QMS planning planned which issuesreferred to
may lead to in 4.1 and the
undesirable requirements
outcomes and referred to in 4.2
subsequent and determine the
failure of the risks and
QMS opportunities that
need to be
addressed.
 Inspectors 5.2.2
3. During a questioned about Communicating
The quality objectives
compliance are not communicated quality the quality
audit, the to the quality objectives(KPIs) of policy:
auditees who inspectors. However,their functional The quality
are the It is a minor non- department in the policy shall:
inspectors in conformity as per ISOform of a be
the incoming
standard 5.2.
questionnaire communicated,
understood and
quality control
applied within
section, were
the organization
not aware of
the company’s
quality policy or
objectives.

8.2.3
The Engineering Review the
Director was requirements
responsible for the for products
conduct of review It is a major non- and services.
of requirements conformity as
related to the
without reviewing Contracts Product claims serve
product. There to provide
were no records of the requirements consumers with
related to product, information about
such reviews and
the product and can
the actions arising. chances of non- help them
The Engineering conforming outputs in determining which
Director claimed products are most
that all contracts
are increased. appropriate for them.
Meeting product
were signed with claims essentially
By not performing means fulfilling the
well-established
clients and the review process, promises or
commitments made
relationships were customer’s, to customers
excellent. He regulatory, and or regarding the
dismissed the need quality,
contract performance, and
for a written record features of its
for contract review
requirements to be products or
unless the auditor overlooked. services.
could prove that his
current review was 8.2.3.2 retain
wrong. He claimed doc info of
that he could recall review
clearly the
important events in
any review which
he had carried out.

Statistical
techniques were Ye in
used extensively in example:Determi
company J for
It is a major ne of there are
monitoring and
measuring of non-conformity. any procedure or
processes and work
product. There instructions
were no concerning the
documented packing (8.5.1
procedures or and 7.5.1 b)
work instructions
for the A: 8.5.1 and
implementation of 7.5.1(b)
statistical
techniques. The
Management
claimed that their
employees were all
fully trained and
produced
comprehensive
training records to
back their claim. In
addition, all their
employees were
able to explain and
demonstrate
correctly the use of
statistical
techniques.

It is a minor non- Audit evidence 8.3.4(b)reviews

conformity. was kept are conducted to
Desktop Retaining confidential by the evaluate the
documented company, which is ability of the
computers were
information for results of design
designed and not a best
review process is and
manufactured mandatory as per practice.
by Company H. development to
8.3.4(f)
Their meet
documentation requirements;
were (f) documented
satisfactory. information of
Design review these activities
was well is retained.
planned and
conducted
every month.
No records
were kept. The
Design Manager
claimed that
such reviews
were
confidential and
therefore no
records were
allowed.

It is a major non- 8.5.1

The work conformity. The
instructions for work instructions
control of a being followed
soldering process doesn’t have the
was found to be latest amendment
one amendment incorporated to it.
out of date. The As per 8.5.1, the
supervisor in charge implementation of
of that shift claimed actions to prevent
that the latest human error; is also
amendment could ignored, since more
defects were
not be
observed, which
implemented could possibly due to
because more human error.
defects were
produced. He
claimed that he had
ten years of
experience and had
exercised good
judgement in not
following the latest
amendment.

8.5.2
The organization
In the stores of a shall control the
unique
company It is a minor non- identification of
manufacturing conformity. the outputs when
traceability is a
pharmaceutical requirement, and
products, some shall retain the
cartons were documented
information
unidentified and necessary to
their shelf life was enable traceability.

not indicated. The

storeman insisted
that he knew the
products well and
no problems would
occur.

Surveillance
audits are periodic
During a surveillance
assessments that
audit in a PCB (printed occur at regular
circuit board) It is a non intervals, such as
fabrication company, annually or semi-
conformity. annually,
the calibration throughout the
laboratory showed certification cycle.
excellent record- The purpose of
surveillance audits
keeping and control of is to verify that the
their calibrated organization
equipment. However, continues to
uphold the
the Laboratory standard's
Supervisor was unable requirements.
to produce records to
7.1.5.2 The
verification of
organization shall
previous measuring determine if the
results when the validity of previous
equipment is found to measurement
results has been
be out-of-calibration adversely
affected when
measuring
equipment is
found to be unfit
for its intended
purpose, and shall
take
appropriate action
as necessary
The work It is a non-conformity. 8.5.1
instructions for the Gpt:The operator
failed to follow the
assembly of a
work instructions,
motherboard used which required all
a desktop operators to ground
themselves using
computer required
wrist-straps during
all Operators to the assembly of the
ground themselves motherboard.
using wrist straps. The supervisor's
One operator did decision to exempt
not follow the the operator from
instructions. She using wrist-straps
based on her claim
claimed that she is
of being allergic to
allergic to the them represents a
straps and the deviation from
Supervisor had established
agreed to exempt procedures and
her. A medical compromises the
certificate was effectiveness of the
quality management
produced by the
system.
Supervisor to back The production of a
his concession medical certificate
towards the by the supervisor to
Operator. support his
concession towards
the operator
indicates an attempt
to justify the
deviation from
established
procedures.
However, the
acceptance of this
certificate without
proper assessment
or validation of its
legitimacy may
further compound
the nonconformity.
A handwritten
amendment was
found on the
incoming
acceptance
procedure which
required a random
sample size of 80 to
be selected from
the incoming lot.
The acceptance
number is 0 and
rejection number is
1.
The amendment
which has no date
or approval,
comprised
changing the
original sample size
of 50 to 80. The
incoming Quality
Control Engineer
claimed that he had
exercised his
initiative to correct
the mistake. He
produced the latest
Mil Std 105E which
showed that for
sample code letter
J, the sample size is
n = 80, Ac = 0, Re =
1 for 0.65%
acceptable quality
level for the single
normal inspection.
He claimed that he
had informed
management of the
“error” but had not
received a reply. In
any case, he
claimed that the
impact of his
unapproved change
was negligible
The soldering
section in a high-
tech disk drive
manufacturing
company was
unable to produce
training records for
three new
operators. The
operators for the
critical soldering
operations were
required to pass a
test before they
were permitted to
perform the
operation. The
Supervisor-in-
charge claimed that
for new operators
the records were
kept by training
department and he
was still waiting for
the copy of
qualification and
training records
from the Training
Department. He
produced a set of
inspection records
from the Quality
Assurance
Department to
show that the three
new operators
could produce good
soldering work. In
the meantime he
telephoned the
Training
Department to
forward the
training records..

NON-CONFORMITY REPORT
CASE NO DESCRIPTION AUDIT
OF NON- EVIDENCE ISO 9001
CONFORMITY CLAUSE NO.
AND
REQUIREMENTS
It is a nonconformity.