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8/22/2022

Internal Auditor

Delivered by:

Course Outlines - Agenda


 Introduction to auditing and inspection

 A brief intro to BRCGS Food Safety standard

 When/why we audit and different types of audit

 Preparing to audit and checklist preparation

 Auditor skills and attributes

 Conducting the audit and Reporting the non-conformances or findings

 Preparing an audit report

 Recap and practice

Course Objectives

By the end of the


course you will
be able to:

 Understand the audit and inspection process

 Be aware of the auditor skills and tools

 Be able to prepare checklists and questions

 Be able to carry out effective internal audits

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Section 1

Definition

What is a Process

Input PROCESS Output


(set of interrelated or
interacting activities which transforms
inputs into outputs)

Resources
(to enable transformation to occur)

1. Definition

Key elements of a Process

• People
• Equipment
• Materials
• Information
• Work Environment

1. Definition

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What is an Audit

BRCGS Food Safety issue 9 definition:

ISO 9000 : 2005 definition


A systematic, independent and documented process for obtaining objective
evidence and evaluating it objectively to determine the extent to which the
audit criteria are fulfilled.

1. Definition

What is an Audit
set of requirements used as a
An Audit reference against which objective
evidence is compared
systematic, independent and
documented process for obtaining
Audit audit evidence and evaluating it
objectively to determine the extent
evidence to which the audit criteria are
fulfilled
records, statements of fact or
Audit other information which are
criteria relevant to the audit criteria and
verifiable

1. Definition

What is an Audit Process?

1. Definition

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Key areas to audit within a process


List the key areas to audit within a process

Work
People Equipment Materials Information
Environment

1. Definition

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Key areas to audit within a process


List the key areas to audit within a process
Key areas an auditor should be looking for when auditing these
elements within a process

1. Definition

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What is a Food Safety Audit

- Centered on the defined requirements set out in food safety


standards, legislation and company QMS

- It focuses specifically to the safe production and the supply of


food products

- It provides information upon which the food business can act


to improve its performance

- Requires knowledge in different fields (i.e. management


processes, hygiene, risk assessments, HR, H&S, microbiology,
chemistry, engineering etc.)

1. Definition

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What is an Inspection

BRCGS Food Safety issue 9 definition:

In simpler terms:
Comparing systems and practice with standards and procedures, to establish
compliance and highlight non-compliance.

1. Definition

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Audit vs Inspection

Inspections are a “do” and audits are a “check”.

An inspection is typically something that a site is


required to do by a compliance obligation.

An audit is the process of checking that compliance


obligations have been met, including that the required
inspections have been done.

1. Definition

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Examples of Audits and Inspections

1. Definition

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BRCGS FS i9

1. Definition

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Why auditing is important

• Evaluate the effectiveness of the


organisation management system
• To comply with the BRCGS Standard (and
other GFSI benchmarked Standards),
contract obligation and legal compliance
• An effective method for involvement and
motivation of personnel to identify potential
problems
• Continuous process of improvements
• Identify potential issues before they occur

1. Definition

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Section 2

BRCGS FS General

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Heritage of the BRCGS Global Standards


Pre 1996 • Brand owners inspect their own suppliers

1998 • Brand owners join to create a common Standard


for Food

2000 • First Standard approved by the GFSI

2015 • BRCGS Standard for Packaging and Packaging


Materials Issue 5 published
• BRCGS Standard for Storage and Distribution
2016 Issue 3, Consumer Products Issue 4 and Retail
Issue 1 published

2017 • BRCGS Standard for Agents and Brokers Issue 2


published

2018 • BRCGS Standard for Food Safety Issue 8

2. BRCGS FS - General

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Food Safety Standard

2. BRCGS FS - General

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Food Safety Standard


The Standard has been developed to take a common
sense approach towards achieving certification, by
covering the following requirements:

• Senior management commitment


• The food safety plan - HACCP
• Food safety and quality management systems
• Site standards
• Product control
• Process control
• Personnel
• High-risk, high-care and ambient high-care
production risk zones
• Requirements for traded products

2. BRCGS FS - General

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Format of the Standard

PART I
Introduction
PART II
Requirements
PART III
Audit Protocol
PART IV
Operation and Governance of the Scheme

Appendices

2. BRCGS FS - General

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Fundamental requirements

Within the Standard certain requirements have been designated as crucial to the
establishment and operation of an effective food quality and safety operation:
• Senior management commitment and continual improvement (1.1)
• The food safety plan – HACCP (2)
• Internal audits (3.4)
• Management of suppliers of raw materials and packaging (3.5.1)
• Corrective and preventive actions (3.7)
• Traceability (3.9)
• Layout, product flow and segregation (4.3)
• Housekeeping and hygiene (4.11)
• Management of allergens (5.3)
• Control of operations (6.1)
• Labelling and pack control (6.2)
• Training: raw material handling, preparation, processing, packing and
storage areas (7.1)

2. BRCGS FS - General

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Statement of Intent (SOI)

SOI

Clause

The Statement of intent sets out the expected outcome


of compliance with the particular clauses.
All sites must comply with the SOI.

2. BRCGS FS - General

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“Shall” vs “May”

Shall Criteria MUST be included within a policy or procedure.

May Guidance for incorporations in company policies and


procedure.

2. BRCGS FS - General

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Other points to note

▪ Term “Appropriate”
▪ Documented procedures
▪ Validation
▪ Verification
▪ Monitoring
▪ Annual frequency

2. BRCGS FS - General

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Colour coding

Production processes represent the key activity on site and auditing


these areas forms a significant proportion of the audit. As an aid to this
process, the requirements of the Standard have been colour-coded.

2. BRCGS FS - General

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Colour coding

2. BRCGS FS - General

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Section 3

Audit Types

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What can we audit

- Companies own QMS


 Quality manual
 Procedures
 Policies
 Work instructions
 Records

- Group standard
- Customers standard
- GSFI or ISO standards
- Legislation

3. Audit Types

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When can we audit

1. If there are any changes to factory/plant or processes

2. In response to customer complaints or identifications of internal failures

3. To meet and satisfy requirements of the internal audit schedule

3. Audit Types

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Why should we audit

Audits are an important part of confirming compliance:


– It provides information to the management team to enable them to take the right
decisions

– It can identify improvements, define responsibilities and drive completion of action


points within agreed timescales

Auditing is a tool to decide if the business is producing safe food:


– Are we doing the right things?

– Are we doing what we say we are doing?

3. Audit Types

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How do we audit

IA EA EA EEA

3. Audit Types

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How do we audit

AUDIT

3. Audit Types

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Other audit types

Systems Check against a set pf procedures, products,


areas etc.
Compliance Are systems being followed

Investigative Specific (ie customer complaints, RCAs)

Full audit All activities of the company, operation or


business
Partial audit Only selected / relevant activities or areas are
included in the audit
Desktop / Remote Limited to the examination of documents, away
from site, or online
Gap audit (not GAP) Preliminary audit to determine compliance
against a certain standard

3. Audit Types

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Section 4

Audit Preparation

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Internal audit process


(Extract from ‘Best practice Guideline: Internal Audit’ – Figure 1)

Identify audit requirements Agree non-conformities and


Agree audit scope responsibility and timescale for
and prepare checklist
corrective action

Establish audit timing Verify and document corrective


Develop audit schedule
– when it will be carried out actions as effectively completed
through risk assessment
– how long it will take

Collect and document objective Communication to senior


Identify auditor who is appropriately
evidence recording conformity as management of audit findings
trained and independent well as non-conformity for review

4. Audit Preparation

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Audit Planning

Preparing an audit schedule


Audit scope
Preparing an audit checklist
Pre notification

4. Audit Preparation

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Audit Schedule 1 = Audit Scheduled


2 = Audit undertaken
3 = Audit Closed Out (only to be added
when all nonconformities from the audit
have been closed out)

Procedure/ Process/ Policy Ref Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Auditor

HACCP/ HARA 3 2 J. Smith

Traceability 3 2 A. Wilson

Labelling 3 2 A. Wilson

Senior Management
1 J. Smith
Commitment

Internal Audits 1 A. Wilson

Supplier Approval 1 C. Scott

Control of Non-conforming
1 A. Wilson
Product
Allergen Management 3 2 C. Scott

Document Control 1 J. Smith

4. Audit Preparation

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Audit Schedule

4. Audit Preparation

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Audit Scope

What do you The extent and


understand to be boundaries of the
the audit scope? audit

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Audit Planning
Audit Objective – To evaluate the effectiveness of the Purchasing Process Audit Criteria – Purchase Process 123 v3

Department/Scope - Purchasing – HQ Main office


Audit Start Date/Time: 03/xx/xx 09.00 Auditor: J Bloggs
Audit Finish Date/Time: 03/xx/xx 15.00

Feedback (Closing Meeting) 03/xx/xx 14.30


Department Representatives: Mrs Purchasing Manager
Purchasing Assistant(s)
Miss Operations Manager
Date Time Auditor Area/Process

03/xx/x 09:00 J Bloggs Opening meeting


x
09:30 J Bloggs Mrs Purchasing Manager – Department Objectives

11:00 J Bloggs Mrs Purchasing Manager - Type and extend of control

11:30 J Bloggs Coffee Break

11:45 J Bloggs Miss Operations Manager – Communication with Purchasing

12:15 J Bloggs Lunch

13:15 J Bloggs Mrs Purchasing Manager – Review historical documents to test system, follow up audit
trails.
14:30 J Bloggs Closing meeting

15:00 J Bloggs Finish

Signed by Auditor: Accepted by Auditee:


Form No 1 - Issue 1/September 20xx

4. Audit Preparation

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Audit Checklist

The contents of the


checklist is determined
by the audit criteria

Audit ref: Date: Auditor:

Procedure: Area:
Ref Requirement/ Evidence Non Auditee
question Conformity/
Observation

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Audit Checklist

4. Audit Preparation

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Audit pre-notification

This should outline:


• Auditor
• Audit date and time
• Audit scope
• Personnel
• Documents
• Confirmation

4. Audit Preparation

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RECAP - Preparing for an audit

An audit is about gaining information

Information can be obtained in a number of ways:

1. Speaking to people (interviews)

2. Document/record review

3. Observations of activities and conditions

4. Audit Preparation

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RECAP - Preparing for an audit

Plan ahead:

1. What/where is it that you are auditing?

2. Who/what needs to be audited?

3. What extra documents/processes do you think may need


to be checked in this area (e.g training records, production paperwork)
4. Have you familiarised yourself with the audit template?

5. Book in the audit with the auditee.

4. Audit Preparation

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Section 5

Auditor skills and


attributes

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Auditor Desirable Qualities

 Good Communication skills  Tact & Diplomacy


 Objectivity  Patience
 Open mindedness  Maturity
 Analytical  Tenacity
 Good Judgment  Self Motivation
 Presence  Polite & Friendly
 Helpful & Constructive  Neutral
 Informative  Focussed
 Perceptive  Honest

5. Auditor skills and attributes

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Auditor Competencies (GFSI)

Communicate with all operational levels in


the auditee food business

Assess non-verbal communications

Discuss audit findings openly and honestly

Present audit findings to auditee and


management clearly, concisely and
objectively

Cite the evidence for non-conformities

5. Auditor skills and attributes

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Auditor Competencies (GFSI)


Establish a working relationship with the auditee that
supports the intent and objectives of the food safety
audit

Maintain objectivity during the audit process

Maintain auditee confidentiality

Maintain composure; avoid arrogance, anger or other


negative behaviours

Recognise a conflict of interest

5. Auditor skills and attributes

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Communication

Sound and tone


of your speech

Style of your
Body language
speech

Facial Listen, hear &


expression understand

5. Auditor skills and attributes

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Communication

What does the auditor need to do?

Establish a
Give a good Communicate
Explain the positive Explain
first with all levels
audit working findings
impression of staff
relationship

5. Auditor skills and attributes

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Auditor Attributes

Auditors should possess the


knowledge and skills
necessary to achieve the
audit objectives, such as:
• Generic knowledge and
skills
• Discipline & sector
specific knowledge & skills

5. Auditor skills and attributes

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Auditor Attributes
▪ Knowledge of the
requirements relating to
the areas being audited
e.g. Standard or process
▪ Full understanding of the
process*

Knowledge ▪ Awareness of company


policy*
▪ Awareness of company*
procedures
▪ Knowledge of the law*
▪ * As it relates to the areas that you are
auditing

5. Auditor skills and attributes

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Auditor Attributes

Support and
Authorisation commitment of senior
management

5. Auditor skills and attributes

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Auditor Attributes

▪ Mature and open minded


▪ Sound judgement
▪ Analytical and technical
skills
Integrity
▪ Understand complex
issues
▪ Ability to perceive
situations realistically

5. Auditor skills and attributes

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Auditor Attributes

▪ Ethical
▪ Tactful
▪ Observant
Professional
▪ Courage of conviction
▪ Adaptable
▪ Culturally sensitive

5. Auditor skills and attributes

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Body Language - Nervous

• Body produces adrenaline –


‘fight or flight’ response
• Looking down
• Dry throat
• Sweating
• Fidgeting with hands or hair
• Foot tapping

5. Auditor skills and attributes

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Body Language - Confident

• Eye contact (2-3 seconds)


• Standing tall and straight
• Smiling
• Firm handshake (Western
cultures)
• Authoritative voice
• Taking the lead

5. Audit Style and Approach

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Body Language - Aggressive

• Pointing or jabbing a finger at


you
• Standing too close
• Red face
• Prolonged eye contact
• Muscle tension – clenched fists,
frowning, shaking
• Banging or kicking things

5. Auditor skills and attributes

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Body Language – How can you respond?

• Explain that you are • Beware - don’t let • Explain the importance of
not auditing people, them lead the audit! the audit and their co-
but the site • Stay in control and operation
• Inform them of what check your list • Be patient but firm in
you are doing • Stop them talking handling difficult
• Ask an open when necessary situations
question to get them • If it is a manager, refer
talking them to senior
management commitment
• Interview another person if
auditee is difficult (if
possible)

Nervousness Confidence Aggression

5. Auditor skills and attributes

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Auditor requirements

Work
experience

Audit
Qualifications
training

Product
Education category
competence

5. Auditor skills and attributes

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Section 6

Conducting the audit

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Audit layout

Audit tools

Dealing
Objective
evidence with a
non conformity

Opening Conducting Closing


meeting the audit meeting

6. Conducting the Audit

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Opening Meeting

What topics do you think an opening


meeting agenda should cover?
Opening meeting agenda:
– Audit scope
– Availability
– How the audit will be reported
– Importance of the audit

6. Conducting the Audit

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Objective Evidence

How can you get objective evidence during an audit?

Observing processes

Is information Interviewing personnel


based on facts
that can be
Reviewing documents
proved through:
Analysing data

6. Conducting the Audit

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Objective Evidence

Company policy
Objective
evidence is used Company procedure
to demonstrate
when the following Legislation
have been
contravened or Standards
met:
Customer requirements

6. Conducting the Audit

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Interviewing personnel

“Open Questions”
used to assess
general
understanding

“Challenging & Probing


Questions” used to
evaluate compliance on
critical issues

“Summarising & Closed


Questions” used to
confirm auditors
understanding

6. Conducting the Audit

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Communication and listening


Do not ask too
many questions at
once

Ask for clarification


where the Maintain good eye
information given is contact
unclear

Use ‘pregnant
Smile and look
pauses’ to extract
interested
more information

Give the auditee


enough time to
answer your
questions

6. Conducting the Audit

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Audit Tools

• Make appropriate eye contact


• Look interested

Listening •

Short pause to extract more information
Give the interviewee time to answer

• Checks working practice is the same as


the documented procedure

Observing • Provides a better understanding of the


standards being worked to
• Identifies areas for further investigation

6. Conducting the Audit

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Key principles of Auditing

Review Check Challenge

6. Conducting the Audit

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RECAP - Audit Objectives

Auditing is the ‘Checking’ and ‘Acting’

– It provides information to the management team to enable them to take the


right decisions

– It can identify improvements, define responsibilities and drive completion of


action points within agreed timescales

Auditing is asking

– Are we doing the right things?

– Are we doing what we say we are doing?

6. Conducting the Audit

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RECAP - Audit approach

1. Be objective

2. Be thorough, detailed and ask questions

3. Ensure the reply gives an answer to the question

4. Highlight areas where there is room for improvement


through Non conformances or recommendations
(dependent on scale)

5. Don’t be afraid to challenge

6. Conducting the Audit

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ASK LOOK /
LISTEN

Audit
Loop
RECORD CHECK

6. Conducting the Audit

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Section 7

Raising Non-conformities

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What is a non-conformity?

the non-fulfillment of a specified product


safety, legal or quality requirement or a
specified system requirement
BRCGS

a non-fulfillment of a requirement
EN BS ISO 2011:2018

7. Raising NCs

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NC Classification
• Where there is a • Where there is a • Where a clause
critical failure to substantial failure to has not been fully
comply with a meet the requirements of met but, on the
food safety or a ‘statement of intent’ or basis of objective
legal issue any clause of the evidence, the
Standard or a situation is conformity of the
identified which would, product is not in
on the basis of available doubt
objective evidence, raise
significant doubt as to
the conformity of the
product being supplied

Critical Major Minor

7. Raising NCs

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NC Classification

Critical Major

Minor

7. Raising NCs

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Dealing with NCs

7. Raising NCs

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Dealing with NCs

• Undertake corrective action to remedy


the immediate issue
• Undertake analysis of the underlying
cause of the non-conformity (root cause)
The site • Develop a preventative action plan to
address the root cause and prevent
should recurrence

7. Raising NCs

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Dealing with NCs

When highlighting any non conformances, do so:

• Politely
• With no criticism of person or system
• Give the personnel being audited an opportunity to put their point
of view
• Emphasize on the fact that the site needs to find the root cause and
possible preventive actions
• Ensure acknowledgement of the finding understood
• Collect all necessary information for writing out the finding that has
objective evidence linked to it

7. Raising NCs

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Preparing Closing meeting


Inform the auditee the audit is completed

Arrange a time to undertake the closing meeting

Find a quiet area to review your checklist

Identify the non-conformities you intend to raise

Summary of your audit findings

7. Raising NCs

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Closing meeting
Confirm area covered by the
audit

Provide overview of positive


points raised during the audit

Read out non-conformities


(where appropriate)

Agree timescales for corrective


action

7. Raising NCs

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Section 8

Audit Report

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Audit Report

What do you expect to be included in the audit report?

8. Audit Report

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Audit Report
Audit Ref: Auditor: Date:
Auditee: Procedure:

1. Reason for Audit:

2. Audit Findings Summary:


(To include general statement, positive points and areas for improvement where appropriate)

3. Details of Non Conformities


Ref Detail Cat Corrective and Preventive Action Resp. Person Comp. By

4. Audit Close Out


4.1 Method used to verify effectiveness of corrective and preventive action.

Auditor (signature): Date:

8. Audit Report

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Audit Report

8. Audit Report

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Audit Follow-up

There are three


types of audit
follow-up:

Auditee to
provide Cover at the next
Re audit
documentary audit
evidence

8. Audit Report

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CAPA Effectiveness

Possible
verification
methods:

Interview
Review any
personnel on Check
amended
corrective training Review Observe
documents
and records where process process
e.g. policies,
preventive training has records activities
procedures
action carried been given
etc.
out

8. Audit Report

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Section 9

Practice

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RECAP
• What have you learned?

• What do you think are the main auditor


responsibilities?
 To liaise with the auditee
 To manage the audit
 To accurately record audit findings
 To report the results to the auditee
and all other concerned parties (e.g.
the management team)

9. Practice

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RECAP

9. Practice

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RECAP

9. Practice

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Section 10

Course Assessment

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Auditing Practice

1. Prepare for an audit

2. Undertake an audit

3. Report an audit

10. Course Assessment

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Let’s keep in touch

Delia Baban
Email:
info@dbfsconsulting.com
Mobile: +44 7513 401085

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