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Facilitator: Dr Indrani Ghose, Principal Counsellor, CII-FACE
Date: 28.09.13
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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
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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
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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
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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
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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.
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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.
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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
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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
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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
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����� 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
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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
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� Records
� Activities
� Interviews
� Objects
� Understanding
� Use of PDCA approach
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� ����������� ����� 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
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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
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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
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150
700
150
Total 1000
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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
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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:
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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
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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
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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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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
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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.
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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
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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
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Industry leverages
Industry to create
world class Indian
Food Chain
Creating Role Models for Capacity Building