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Facilitator: Dr Indrani Ghose, Principal Counsellor, CII-FACE

Date: 28.09.13

1

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2

Audit Maturity

Matrix

Requirement

ExcellenceAssessment

Compliance

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Audit Principles

� Practice integrity & Professionalism.

� Present fair and truthful results.

� Exercise due professional care.

� Ensure confidentiality.

� Ensure Independent and impartial audits

� Practice evidence-based approach for reliable findings

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Audit: Systematic, independent and documented

process for obtaining audit evidence and evaluating it

objectively to determine the extent to which audit

criteria are fulfilled

Audit Scope: Defined Boundary of the Audit

Guidance Document on Management System Audits

(FSMS/QMS/ others): ISO 19011: 2011

77

SummaryThe Prime roles of an auditor are to determine

� D Does the FSMS documentation meet the requirements?

� I Has the organization implemented the FSMS?

� E Is the FSMS effective & efficient ?

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Objectives

� Compliance to ISO 22000:2005

� Contract / Project

� QMS / FSMS

Scope

� Products, activities, departments

� Agreed between auditee and auditor

9

Auditee/ Assessee: Organization or its representative being

audited

Auditor/ Assessor :- Person with the competence to conduct an

audit/ assessment

Audit/ Assessment Criteria - Set the policies, procedures or

requirements

Note : criteria are used as a reference against which evidence is

compared.

Audit/ Assessment Evidence - Records, statements of facts or

other information, which are relevant to the Criteria and

verifiable

Note : evidence may be qualitative or quantitative

10

Audit Findings: - Results of the evaluation of the

collected audit evidence against audit criteria

Note : Audit findings can indicate either conformity or

nonconformity with audit criteria or opportunities for

improvement.

Audit Conclusion: - Outcome of an audit , provided by

the audit team after consideration of the audit

objectives and all audit findings

Validation and Establishment of Food Safety Management System Processes

Monitoring

Conducting a planned sequence of observations or measurements to assess

whether control measures are operating as intended

Correction

Action to eliminate a detected nonconformity

Corrective Action

Action to eliminate the cause of a detected nonconformity or other undesirable

situation

Verification

11

1212

Types of Audit

1stParty

(internal)

Conducted by or on behalf of the organization itself for

internal purpose and can form basis for an organization’s self

declaration for conformity

2ndParty

(supplier) Conducted by parties having an interest in the organization

like customers or other persons on their behalf

3rd Party

(external)

Conducted by external independent organizations, such

organization’s provide certification of conformity with ISO

9001, ISO 22000, ISO 14000 and Codex HACCP

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� Establish Audit Program

Set of one or more audits planned for specific time frames and directed towards a specific purpose

� Set Program objectives.

To support management system objectives.

To direct audit planning & audit activities

� Consider potential audit program risks.

13

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Every audit cycle passes through Following four phases: -

� PHASE -1 - Planning

� PHASE -2 - Execution

� PHASE -3 - Recording and

� PHASE -4 - Close out

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� Establish a contact with auditee

� Collect Priliminary information about the organization and

role in food chain.

� Priliminary information about roles and responsibilities of

auditee

� Plan an audit team

� Plan for an audit (audit plan)

� Plan / Draft a audit checklist.

1616

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� Initiating the audit

• Definition of objectives, scope and criteria

• Determination of feasibility of audit

• Establishing the audit team

• Initial contact with auditee ( if required )

� Documentation review

� On-Site Audit activities preparation

• Planning

• Work assignment

� Procedures

� Checklist

� Sampling plan

� Forms

1717

Preparing a ChecklistGeneral Guidelines

� Study the documented Food Safety Management system

� Prepare separate lists for each function / area

� Consider time allocated and key elements to be assessed

� Use the checklist as a tool

� The auditor determines the style and detail

References

� Use the documented system / standards/ auditor guide

� Use your experience /other information about the

organization ( Know problems and Public knowledge)

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Opportunities for making Mistakes / Defects

� Customer Complaints

� Internal Rework, Reject,

Concession Reports

� Shelf life Expiry

� Waiver reports

� Process / Product Audit

Reports

� Material, Tools,

Consumables,

Energy Consumption Norms

� PDCA Cycle

� Pilot Run / Pre-production

� Machine Break Down Data

� Absenteeism Rate in

Different Work Area

� Delayed Delivery Report

� Competitive Advantage

Points

� Cost of Quality

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� Opening meeting

� Onsite assessment

� Making onsite observations

� Making onsite notes

� Conducting closing meetings

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� Opening Meeting

� Collection of information

� Verification of information

� Compiling audit findings

� Report preparation

� Closing Meeting

� Report approval and distribution

� Follow up

2121

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Records

Documents

Interviews

Observations

Feedback

Databases, Websites

Significance

Relevance

Acc

ura

cy

Ex

isten

ce

Remember : Only objective evidence is permitted

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A factual statement that can be verified

� Not based on opinion or preference

� Based on data supporting the existence or verity of something.

� May be obtained through observation, measurement, test or other

means.

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� Documentation

� Implementation

� Effectiveness

� Efficiency

Auditing Skills

� Time Management

� Fact Finding

� Reporting

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Representative

Food Safety Management System

� Scope

� Activities

� Random

� Auditor selection

Assess a limited sample of activities to come to an informed judgment on

the general status of the food safety management system

2525

����� 2����� ����� Make sure you are asking the right person

� Open Questions : How, Where, what , who, when,

justification?

� Closed and Leading Questions

� Confirm your understanding with closed questions

� Listen

� Please, show me - Look & Listen

� Repeat, rephrase and if needed reconfirm

� ‘Silly’ questions may have to be asked

� Silence can be useful

� Remain natural

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Reading Communication

Observing Questioning

Listening Use of thought speed

First question Observe Body Language

To and fro checking Use of Unasked Question

Establish Rapport with

Auditee

Using Aide Memoire

(Checklists)

Take Notes

2727

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� Statements of Food Safety Management Policy and Food Safety

Management objectives

� Food Safety Management manual adequately covering scope,

procedures

� Documents to ensure effective planning, operation and control of

processes

� Procedures for control of documents and records

� Instructions

2828

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� Records

� Activities

� Interviews

� Objects

� Understanding

� Use of PDCA approach

2929

� ����������� ����� Records / Results

� Measurements

� Milestones

� Management reviews

� Customer feedback

� Timely corrective action which prevent

recurrence

� Right versions of documents in use

� Rigorous use of PDCA approach

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� Reporting the audit findings is the recording phase of the audit.

� Based on the audit evidence the auditor concludes audit finings

� Audit conformities

� Audit Non conformities.

� Auditor concludes the audit in the form of audit report.

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01. What is a Non compliance?

Non-fulfillment of a specified requirement:

Not doing it

Partially doing it

Doing it the wrong way

Specified requirements:

FSMS standard (ISO 22000) or FSSA Requirements

Statutory or regulatory requirements

Conditions of customer contract and ultimate consumer

Implemented food safety management system

Nonconformity

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The Observation

The Attribution

The Explanation

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Company under Audit : Note Number:

Area under review :

Category MAJOR / MINOR (DELETE ONE)

Observation:

Attribution

Explanation

Auditor :

Date :

Acknowledged by :

Date :

Comments / Agreed Action Target Date :

Signature : Date :

Action Taken

Signature : Date :

NCR Closed Sample Audit Signature :

Prepare Audit Conclusions.

� Review audit findings and other related information.

� Discuss and consider your audit conclusions.

� Formulate and document your audit conclusions.

� Prepare recommendations (if audit plan requires it).

� Consider audit follow-up (whenever this is applicable).

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PHASE – 4- Audit close out

� Based on the audit conclusion closure of the audit non

conformities.( by the auditee)

� Verification of the closure of the non conformities

through an evidence or an onsite verification

3636

Closing meeting – agenda

� Chaired by lead auditor

� Introduction

� Thanks for assistance and hospitality

� Re-state objective and scope of the audit

� Disclaimer for sample audit

� Emphasis on negative reporting

� Present the findings

� Explain the conclusion/recommendations

3737

Closing Meeting – Agenda (contd..)

� Reconfirm confidentiality

� Diverging opinions

� Clarify auditee’s doubts

� Hand over copy of the report

� Ask for corrective action plan / commitment

� Record attendance and proceedings

� If specified by audit objectives, make recommendations

for improvement but emphasis that recommendations

are not binding

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Close out of Non Conformities

� Closure of Non conformities based on evidence.

� Onsite verification of the close out of Non conformities.

� Recording of the closure of Non conformities (as a reference for the next assessment)

Follow-up on audit.

� Consider whether remedial actions should be taken.

� Ask auditee to provide remedial action status reports.

� Verify that remedial actions were actually taken.

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Manage audit program outcomes

� Ensure that audit program outcomes are managed efficiently and effectively.

� Ensure that audit findings are evaluated.

� Ensure that root cause analyses are reviewed.

� Ensure that remedial actions are reviewed.

� Ensure that audit reports are reviewed.

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Monitor , Review, Improve the Audit Program.

� Monitor the implementation of audit program.

Modify your audit program whenever evidence indicates that change is required.

� Review and improve audit program.

Review your management system audit program.

Summarize your results and report to top management.

Improve your management system audit program.

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� Establish an auditor evaluation process.

� Develop a process to evaluate audit team members.

� Plan the evaluation of audit team members.

� Evaluate the competence of audit team members.

� Maintain the competence of audit team members.

� Improve the competence of audit team members.

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� Methodology to achieve results based on audit objectives

� Auditing Principles, Techniques

� Organizational Systems and Procedures

� Knowledge on Criteria (e.g FSMS/QMS Standard, Customer Requirements )

� Legal requirements (FSSA, Customer’s, Sector Specific)

� Domain and Sector Specific Technical Knowledge and skills

� Team Work and Team Leadership .

� Multidisciplinary Processes (Production, Quality, Customer related, Purchasing, Maintenance, Warehousing, Transportation, Packaging etc)

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� Professional

� Ethical (be truthful and honest).

� Versatile (be adaptable and flexible).

� Perceptive (be attentive and watchful).

� Receptive (be willing to learn and improve).

� Observant (be aware of your surroundings).

� Collaborative (be capable of working with others).

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� Open-minded (willing to consider alternatives).

� Decisive (able to draw timely conclusions).

� Tenacious (persistent and focused).

� Self-reliant (act independently).

� Diplomatic ( tactful and discreet).

� Respectful (sensitive to the auditee's culture).

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How to assess Food Safety Excellence based on

the CII Food Safety Maturity Model

47

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150

700

150

Total 1000

49

CII Food Safety Maturity Assessment

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CII Food Safety Maturity Score Bands

Maturity Bands

� Implication of % marks awarded :

� There is comprehensive evidence of implementation of world class

standards in all relevant areas: 90-100 : World class

� There is clear evidence of advanced standards of implementation in

most relevant areas but is short of world class standards : 65-85:

Advanced

� There is evidence of implementation in several relevant areas and can

be categorised as Competitive: 40-60: Competitive

� There is evidence of basic level of implementation and covers some

relevant areas: 15-35 : Basic

� No evidence or anecdotal : 0-10 : Anecdotal

Least Count : 5

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Assessment Evidence: Strengths and Opportunities

for Improvement of the enablers and outcome of

the system against the maturity band provided.

1. Strengths & OFIs of the system under

assessment

� Enablers

� Outcome

2. Identify Maturity bands & Scores

through a Consensus process

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Section

Flow diagrams, Process Steps and Control MeasuresB 2. 4

No. CheckpointsY / N

/ NARemarks

4.1Flow diagrams Enter text here

4.1.1 Are flow diagrams prepared for

all products or process steps?

4.1.2 Is the accuracy of the flow

diagrams verified by the food

safety team by onsite checking?

Assessment Criteria of Food Safety Excellence against

4 Tier Model and Maturity Band

53

Assessment Sections

� Section A: Self Declaration on Statutory and Social

Compliance

� Section B: PRP, HACCP, FSMS

� Section C: Sector Specific GMP

� Section D: Change Management Initiatives:

54

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Model 2013

Marks Distribution: Criteria 2, 3

Section B : Food Safety Practices Highest Possible

Marks 700

B 1 Pre Requisite Programs (based on ISO 22002-1) 300

B 2 HACCP based on ISO 22000 200

B 3 Food Safety Management System Structure based on

ISO 22000

200

Section C : Sector Specific Good Manufacturing Practices (GMP)Highest Possible

Marks 150

C Sector Specific GMP based on relevant Codes & Best Practices 150

Section D : Change Management InitiativesHighest Possible

Marks 150

D Change Management Parameters 150

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Section B1 : Pre Requisite ProgramsHighest Possible

Marks 300

No. Checkpoints Total

1 Establishment Construction, Environment, Location 15

2 Layout of Premises and workplaces 15

3 Utilities – Air, Water & Energy 15

4 Waste Disposal 15

5 Equipment suitability, cleaning and maintenance 24

6 Management of Purchased material 24

7 Measures for prevention cross contamination 24

8 Cleaning and sanitizing 30

9 Pest Management 30

10 Personal Hygiene and employee facilities 30

11 Rework 30

12 Warehousing 24

13 Product Information and consumer awareness 12

14 Food Defense, Bio vigilance and Bio terrorism 12

Model 2013

Criteria 3, Section B1: Based on ISO 22002-1

57

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Section B2 : Risk Assessment based on HACCPHighest Possible

Marks 200

No. Checkpoints Total

1 Food Safety Team 10

2 Product Characteristics 10

3 Intended Use 7

4 Flow Diagram 10

5 Description of Process Steps 15

6 Hazard Analysis 40

7 Risk Assessment in new Product Development 10

8 Selection & Assessment of Control Measures 10

9 Establishing Operational PRPs 8

10 Establishing CCP, CL, Monitoring, Recording & Verification in HACCP Plan 40

11 Updating of Preliminary Information 10

12 Verification Planning 10

13 Effectiveness of PRPs, OPRPs & HACCP Plan 20

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Section B3 : Food Safety Management SystemHighest Possible

Marks 200

No. Checkpoints Total

1 Scope 10

2 Documentation Requirements 10

3 Management Commitment 10

4 Communication 20

5 Emergency Preparedness 10

6 Management Reviews 16

7 Human Resources 20

8 Customer Satisfaction Management 10

9 Traceability 10

10 Correction 10

11 Corrective Action 10

12 Handling of potentially unsafe Products 10

13 Withdrawals (Product Recall removed from PRP) 10

14 Validation of the food safety management system 10

15 Control of Monitoring & Measuring Equipments 14

16 Food Safety Management System Verification 10

17 Improvement of FSMS 10

59

Section D : Change Management Initiatives Highest Possible

Marks 150

No. Checkpoints Total

1. Enablers for Change Management Initiatives 45

2. Outcome of system standards, tools, techniques and

operating philosophies

45

3. Recognition and reward of people 30

4. Involvement of the unit in championing and disseminating

the message of Food Safety

30

Section D

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8����Assess Sector Specific requirements and best practices

with respect to the following, as applicable:

Technology, Equipments , Methods, Material

� Maintenance of Air Quality & Environment Pathogen Monitoring

� Mistake Proofing for Hazards control

� Utilities

� Primary Production Chemical Residues control

� CIPs /COPs

� Material of Construction

� Water Treatment Technology

� ETP and Waste Management

� Sensitive Ingredient release

� Others

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62

Section

Sector Specific Good Manufacturing Practices (GMP)

C

No. Checkpoints

Y / N /

NAPartly Findings

C 1 Sector Specific GMP based on

relevant Codes of Practice &

Best Practces

y In addition to regular GMP's being followed at the site, the site

practices specific GMP's that are also Best Practices, as detailed:

1. CIP - Four types of CIP regimes:

a. Cold CIP for all CSD (Carbonated Soft Drinks) lines using a nitric acid

based chemical

b. Hot CIP for Sugar syrup lines using hot caustic

c. Hot+Acid CIP for lines using 6 step hot caustic followed by Phosphoric

acid

d. Hot water CIP for bottled water line using hot water

CIP frequency is every 48 hours for all products .

2. All Surface Electronic Bottle Inspector placed ensures 100% post

bottling check

3. ‘ Sanitation with Excellence’ in Every Place. The site works in

collaboration with Cleanlabs for solutions for in-depth cleaning and

sanitation of equipment thus ensuring microbiological safety

4. Asset Maintenance - Surface cleaning is done using high pressure jet

and appropriate sanitisers

5. Forklift operators - are trained and insured

6. Online gamma rays + photographic cells based on-line inspection

machine for fill height, defective closures and subsequently label

positioning and printed mandatory

7. Mechanised Handling from Loading to unloading to eliminate

manual handling of beverage and packing material.

Highest Possible Score = 150.00 Weightage 1.5000

Evaluated Score = 135.00 Obtained % 90

Example

63

Section

Recognition and reward of people

D 3

No. Checkpoints Y / N / NA Partly Remarks

3.1 How are people rewarded

and recognised for their

contribution to Food

Safety and other

initiatives?

Photographs of Kaizen teams, graphic

representation of achievements including

those of 5S contribute to motivation of

employees. There is a Kaizen scheme in place

to reward and recognise employees on

implemented Kaizens related to 5S and TPM in

manufacturing .Every month Kaizens are

celebrated. There is a portal where Kaizens are

uploaded for sharing best practices.

Assessment of effectiveness of R&R systems

to recognise commendable performances in

areas other than Manufacturing

Improvements in a timely manner was not

evidencedHighest Possible Score =

15

Weightage

0.15

Evaluated Score =

10.5 Obtained %75

Example

Consensus Process� 3 Assessors take part

� Each assessor had captured their allocated findings and had recorded their feedback under the respective section.

� Findings on each section are projected for all 3 assessors on the screen

� Individual scoring is done based on the Maturity band in least count of 5

� If the score belongs to a different band or difference is more than 10, the assessors discuss their justification based on the write up

� Perceptions of world class varies between assessors and this variation is expected. Hence the discussion to share experience and .modify the write up if required to arrive at a consensus.

� Score bands are provided to Jury to offset variation between assessors, if any , after the consensus and calibration process.

64

65

CII National Award for Food SafetyIdentifying Role Models & Promoting Global Benchmarks on Food Safety

Shri K. Chandramouli , Chairman FSSAI,

handing over the Award -2012 to Cargill, Kutch

Increase No. of Trained Assessors

First Ever Street

Food

Participation in

Awards 2013

% Rise in No. of Award Applicants

Companies Benefitted

2013

66

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Street

Food Eateries

Hotels

RestaurantsManufacturing

One of its kind Award on Food Safety in the

country

Wholesale,

Retail Take-

Aways

Small

Medium

Large

Micro

Street

FoodBeverages

Ready

To Eat

Food Certification

Bodies

Dairy

Confectionary

Food

Service

Providers

RestaurantsTea/

Coffee

Spices

Meat

PoultryFood

Retail

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Ready

to Eat

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CateringWholesale

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1. Award

Applicati

ons

Invited

2. CII-FACE

receives LOI

3. Eligibility checked

Application Document

sent

4. Assessor

Training

conducted

for new

Assessor

pool

5.

Refresher

Training for

existing

assessors6.

Assessor

Teams

composed

7. Site Visits

conducted

~100 hrs /

Assessment

8. Feedback

Reports and

scores

reviewed for

consistency

9. Awards

Committee

Meeting to

verify award

conduct

10. Jury

Meeting

finalises

Winners

11.Awards

Gala Night

at CII Food

Safety &

Quality

Summit

12. Despatch Feedback

Reports to Applicants

69

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Industry leverages

Industry to create

world class Indian

Food Chain

Creating Role Models for Capacity Building