MICHAEL IAN OCCEÑA

EFFECTIVE IQA REPORT

WRITING WORKSHOP
 LEARNING
OBJECTIVES:

To enable participants to write

effective ISO 9001:2015 internal audit
reports.

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 COURSE
OUTLINE:
 Section 1 Introduction
(Review of Requirements)
 Section 2 Writing Nonconformity Report
 Section 3 Writing an Audit OFI (Opportunity for Improvement)
 Section 4 Writing an Audit Report
(Executive Summary plus other Audit Report Details)
 Section 5 Conclusion ( Approval, distribution)

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 Section 1:

Introduction
A quick overview about internal audit reporting

Defi nit ion w ere ba s ed o n

ISO 9000:2005

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 ISO 9001 Requirement

An organization needs to demonstrate its ability to

consistently provide products (and/or services) that meet
customer and applicable legal requirements.
One important tool in this regard is the internal audit
report of an organization’s Quality Management System
(QMS)

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 Quality Management System

Figure 2 — Representation of the structure of this International

Standard in the PDCA cycle

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 Quality Management System
The Plan-Do-Check-Act (PDCA) methodology
applies to all processes
• Activities
• • Deploy &
Controls
conform
• Documentation with plan
• Resources
• Objectives PLAN DO
Continual
Improvement

Your
Process

ACT CHECK
• Analyze/review • Measure &
• Decide/change monitor for
• Improve conformity &
effectiveness effectiveness
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 Internal Audit

 A systematic, independent and documented process

for obtaining audit evidence and evaluating it objectively
determine the extent to which audit criteria are fulfilled.

 It is conducted by or on behalf of an organization

itself for management review and other internal
purposes.

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 Internal Audit

 with documented procedure

 Forms are defined
 Auditors are trained
 Program and interval are established
 Implementation of audit plan is recorded
 Audit report is prepared and submitted

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 Audit criteria

 Set of policies, procedures or requirements

 Used as a reference against which audit

evidences are compared in order to generate the
audit findings.

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 Audit findings

 Results of the evaluation of the collected

audit evidence against audit criteria.
 Audit findings can indicate conformity or
nonconformity with audit criteria.
 Opportunities for improvement (OFIs) are also
reported as part of audit findings.

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 Audit evidence

 Records, statements of fact or other information

which are relevant to the audit criteria.
 Basis for the evaluation of system or process
implementation and effectiveness and confirmation
or product or service quality.

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 Audit conclusion

 Outcome of an audit provided by the audit team

after consideration of the audit objectives and
all audit findings.

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 Internal audit records

 Audit program
 Audit plan
 Audit checklist and Audit Notes
 Audit Report, including Audit conclusions and
Recommendations
 Audit Nonconformity Reports (NCR)
 Opportunities for Improvement or OFIs
 Audit Follow-up items (previous NCRs)
 Other records (e.g. audit notification)

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 Internal Audit report

 A collection of audit records presenting the result

of an Internal audit
 It gives an overall summary of the audit activities,
the audit findings and audit conclusions about an
organization’s quality management system, its
documentation and implementation.
 Input to management review

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 Internal audit report

Includes:

 Nonconformity Report (NCR)

 Opportunities for Improvement
 Audit Report Summary

This training will focus on writing NCRs, OFIs,

Audit Report, and Executive Summary

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 Internal audit report

Purposes:

 summarizes audit findings

 presents summary to management
 documents the subsequent actions required
 evidences compliance with internal audit
procedure

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 Internal audit report

Provides:

 complete, clear, concise, accurate records of

audit
Prepared by:

 Lead Auditor (Audit Chairperson).

 Team Leaders and Internal auditors

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 Section 2:

Writing Audit Nonconformity

Report (NCR)

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 Definition

Nonconformity (NC)
 non-fulfillment of a requirement
 Requirement
 Need or expectation that is stated, generally
implied, or obligatory
 can be product requirement (e.g. customer
requirement or legal requirement), process
requirement, or QMS requirement.
 Nonconformity Report (NCR)
 form where an NC statement is recorded

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 Audit Nonconformity

Category of Nonconformity (NC)

 optional; depends on the decision of the
organization; it’s acceptable to have no NC
category at all.
 Typical NC categories
 Minor – single observed gap in QMS
documentation or lapse in implementation
 Major – a system (QMS) breakdown, e.g. that
which results to legal noncompliance or product failure.

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 Basis of a Nonconformity (NC)

 The objective evidence exists.

• The basis of nonconformity can be verified objectively.
 The violated requirement exists.
• The specific clause can be traced back to ISO 9001:2015

 The NC statement is established.

• The detected nonconformity is documented.

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 Writing an NC Report

1. Used the prescribed form.

2. Write the detected nonconformity clearly.
3. Specify evidences clearly and accurately
4. Describe or reference the appropriate requirement (clause).
5. Provide other details such as location, time , shift, etc. as
may be practicable.
6. Provide traceability to the concerned auditor.
An NCR should be able to stand scrutiny and
provide clear basis for root cause analysis and
corrective action.

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 Writing an NCR - tips
Described the detected (observed) nonconformity
clearly – as a deviation from standard, goal, or
desired result or effect.
Write an NC in terms of what, how much, when
& where that will be clear to others.
Do not write an NC as a question or suggestions.
Do not use “lack of”. They provide instant solutions
once they provide or acquire what is lacking.
Do not , or avoid, stating a person’s name.
Remember ,you are auditing a system. It’s the system
or process you should highlight.
Use simple words, Communicate to be
understood, not to impress.

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 NCR form
Minimum content of an NCR form.
• Field of the nonconformity statement and its
evidences.
• Field for corrections (remedial actions)
• Field for root cause analysis.
• Field for corrective, including timeliness and
responsibilities.
• Field of CA implementation and verification

Actual NCR form depends on company’s

decision.

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 3 Parts of a good NC Statement

1. A clear NONCONFORMITY STATEMENT of the

detected nonconformity, problem, lapse or failure.
2. The factual OBJECTIVE EVIDENCE (specific basis) that
supports the statement of nonconformity
3. The factual REQUIREMENT or reference to the
requirement (i.e. the standard)

Depending on the organization’s decision, the NCR form may

have 3 sections for the above, and additional 3 sections for the
root cause analysis corrective action (CA) plan, and CA
verification and close-out.

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 1.0 The Nonconformity statement

• Clearly and sufficiently stated to be understood.

• Unambiguous; linguistically correct
• Contains adequate information to start the
correction and corrective action process.
• NC statement drives the next steps in the corrective
action process. Write it concisely and precisely.
• Remember that a problem well-stated is a
problem half solved.

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 Writing Good NC statement

1. FACTUAL – objective evidence exists

 Evidence is verifiable
Evidence provides clear and specific proof
about the problem or nonconformity.
2. FOCUSED
Focus or direct the NC on the process or specific
part of the system to be improved, not the person.

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 Writing Good NC statement

3.ACCURATE
Accurately reflect the BASIS of the NC (i.e. requirement
violated or not conformed to, is accurately identified)
 ISO 9001:2015 requirement
Customer requirement.
QMS requirement
Legal requirement
4. CONCISE
Write briefly, clearly, and accurately, based on specific
information and facts about the problem or nonconformity.
Avoid “lack of” or “absence of” statement.

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 2.0 The Objective Evidence

• Relevant to the nonconformity statement and the

requirement
• Objective, therefore verifiable

• Based on available information

• Useful for any investigation related to subsequent
correction and corrective action.

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 Key point:

A factual and accurate nonconformity

statement is based on the objective
evidence that supports its existence.

Therefore, if there’s no objective evidence,

there’s no nonconformity.

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 3.0 The Requirement
• The nonconformity statement and the objective
evidence should accurately reflect the REQUIREMENT
deemed violated or not complied with.

Remember:

The quoted or referred requirement is the

beginning and end of any correction or
corrective action.

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 Key point:

The NC statement, objective evidence and

specified requirement must be in harmony
with each other. Otherwise, the corrective
action required might not be accurately
addressed.

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 Workshop 1

1. Divide into groups.

2. Evaluate the given internal audit observations/findings.
3. Write a nonconformity report (NCR) based on the audit
observations/findings.
4. Identify the appropriate ISO 9001:2015 clause
5. Present your output.

Duration: Preparation – 15 minutes

Presentation – 2 minutes / group

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 Section 3:

Writing an Audit Opportunity

for Improvement (OFI)

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 Definition

Opportunity for Improvements (OFI)

 an audit observation considered not yet a
nonconformity at the time of audit but may lead to
nonconformity if left to current condition.
 May include any possible continual improvement
(raising the bar of quality) in the QMS.

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 Basis of OFI

• Audit notes and observations

• Site verification

• Statutory and regulatory compliance

• Confirmed audit interview findings.

• Results of previous NCR CA verification

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 Characteristics of an OFI

• NOT a detected nonconformity

• Could be a potential NC
(early warning for possible risk action).
It should trigger the implementation of action to
address risk and opportunities.
• Could be an area for further improvement
(spiral up of the QMS or its processes)
• Does not suggest specific actions
(NOT the “how”, only the “what”)

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 Value of an OFI

 may lead to possible adverse consequences if action

is not taken soon enough, or if left at current condition
(the consequential risks to the customer or
organization)
 may lead to or provide potential benefits if action is taken
(the potential gains or opportunities)

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 Workshop 2

1. Divide into groups.

2. Evaluate the given internal audit observations/findings.
3. Write an OFI for the given audit observations/findings.
4. Present your output.

Duration: Preparation – 15 minutes

Presentation – 2 minutes / group

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 Section 4:

Writing an Audit Report

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 Content of Audit Report
May include or refer the
following:
a) Audit plan
b) Audit scope and objective
c) Name of organization
d) Audit particulars (date, time, audit team, key persons, sites)
e) Areas planned but not covered
f) Confidentiality statement
g) Audit conclusions
h) Audit recommendations
i) Results of any follow-up activities
j) Distribution list for the audit
report
Except for items g) and h), most of the above can be
Except for items g) and h), most of the above can be
embedded into the prescribed audit report form.

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 Audit Report
 Audit Conclusions may include:
An executive summary which may include
 Strengths and weaknesses of the QMS
 Results of any continual improvements
 Major areas of concern (summary of NCRs)
 Other key performance indicators
 Overall assessment of QMS effectiveness and
compliance standard

Usually the above can be covered in the first

2-3 paragraphs of the audit report.

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 Audit Report
 Possible major areas in executive summary
 Verification of management commitment
 Performance results vs. objectives
 Robustness of internal audit, management
review and continual improvement.
 Customer satisfaction: complaints and status
 Legal compliance
 Impact of significant QMS changes

Usually the above can be covered in the first 2-3

paragraphs of the audit report.

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 Audit Report

• Attached the audit summary from each audit team

to report the process effectiveness of individual
groups.
• Summarize (e.g. by matrix) the audit NCRs per
clause violated to facilitate analysis of the QMS
weaknesses.
• Summarize the status of any follow-
up NCs for verification.

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 Workshop 3

1. Divide into groups.

2. Based on the given audit NCrs, OFIs and relevant audit
note (if any), write an executive summary which can be
used for management review purposes.
3. Present your output.

Duration: Preparation – 15 minutes

Presentation – 2 minutes / group

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 Section 5:

Conclusion

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 Audit Report
 Should be:
• date (based on actual date of submission of report)
• Reviewed and approved – by authority defined in
IQA procedure
• Submitted timely as management review
• Distributed to concerned heads for the subsequent
actions needed
• Record is controlled or maintained (7.5.3)

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 Conclusion and Final Note:
SPREAD THE WORD:

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EFFECTIVE IQA REPORT WRITING WORKSHOP

Thank you for your

attention.