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FSMA FRIDAYS
The Latest Industry News, Updates & Trends
March 2019
MONTHLY INDUSTRY UPDATE
FSMA Related News
Regulation Changes & Updates
Industry Trends
Q&A with TAG
FSMA FRIDAYS
What is FSMA Fridays?
FSMA FRIDAYS
Our Sponsors
FSMA FRIDAYS
Agenda
HELPFUL TIPS
Informal but professional format
Ask Questions (Q&A at end)
Only panelists are displayed
Recording link will be shared
Audio issues: use call-in number
WHAT WE WILL COVER
Planning and Effective Internal Audit
Internal Audit Basics
Audience Q&A
FSMA FRIDAYS
Presenters
Dave Detweiler
Senior VP, Business Development
Rich Simmons
Senior Advisor, Food Safety
Rolando Gonzalez, Ph.D.
Vice President, Public Health
FSMA NEWS
Completing an Effective Internal Audit
for GFSI Standards
FSMA FRIDAYS
Plan the Audit
Conduct the Audit
Documenting Findings
Opening and Closing Meetings
Follow-Up on Corrective Actions
Defining the Internal Audit
FSMA FRIDAYS
Audit Content
Using the GFSI Standard as a base of the audit
Re-structuring the standard audit checklist
Technical requirements needed – understanding the audit requirements
 Audit Schedule
GFSI programs are large and cover many areas of food safety
management
Just like a marathon – you must pace the audit activity to maximize
effectiveness
Pre-arrange and schedule interviews with managers
Plan the internal audit over the year, if possible (a requirement of BRC
Food Standard)
Planning the Audit
FSMA FRIDAYS
FSM EII 11
The standard shall require that the organisation has an internal audit system
in place to cover all activities within the scope of the Food Safety
Management System.
GFSI Audit Requirement
FSMA FRIDAYS
2.5.5 Internal Audits and Inspections (Mandatory)
2.5.5.1 The methods and responsibility for scheduling and conducting internal audits to verify
the effectiveness of the SQF System shall be documented and implemented. Internal audits
shall be conducted at least annually. The methods applied shall ensure:
• All applicable requirements of the SQF Food Safety Code for Manufacturing are audited as
per the SQF audit checklist or similar tool;
• Correction and corrective action of deficiencies identified during the internal audits are
undertaken;
• Audit results are communicated to relevant management personnel and staff responsible
for implementing and verifying corrective actions.
Safe Quality Food (SQF) Standard
FSMA FRIDAYS
FUNDAMENTALThe company shall be able to demonstrate that it verifies the effective application of the food
safety plan and the implementation of the requirements of the Global Standard for Food Safety.
3.4.1 There shall be a scheduled programme of internal audits. At a minimum, the programme shall include at
least four different audit dates spread throughout the year.
The frequency at which each activity is audited shall be established in relation to the risks associated with the
activity and previous audit performance. All activities shall be covered at least once each year.
At a minimum, the scope of the internal audit programme shall include the:
• HACCP or food safety plan, including the activities to implement it (e.g. supplier approval, corrective actions
and verification)
• prerequisite programmes (e.g. hygiene, pest control)
• food defence and food fraud prevention plans
• procedures implemented to achieve the Standard.
Each internal audit within the programme shall have a defined scope and consider a specific activity or section
of the HACCP or food safety plan.
BRC Global Standard for Food Safety Issue 8
FSMA FRIDAYS
3.4.2 Internal audits shall be carried out by appropriately trained, competent auditors. Auditors
shall be independent (e.g. not audit their own work).
3.4.3 The internal audit programme shall be fully implemented. Internal audit reports shall identify
conformity as well as non-conformity and include objective evidence of the findings.
The results shall be reported to the personnel responsible for the activity audited.
Corrective and preventive actions, and timescales for their implementation, shall be agreed and
their completion verified.
FSMA FRIDAYS
BRC Global Standard for Food Safety Issue 8
FSMA FRIDAYS
FSSC 22000:2018
• ISO 22000: 8.4 Food safety management system verification
• 8.4.1 Internal audit
• The organization shall conduct internal audits at planned intervals to determine whether the food safety management system
• a) conforms to the planned arrangements, to the food safety management system requirements established by the
organization, and to the requirements of this International Standard, and
• b) is effectively implemented and updated.
• An audit program shall be planned, taking into consideration the importance of the processes and areas to be audited, as well
as any updating actions resulting from previous audits (see 8.5.2 and 5.8.2). criteria, scope, frequency and methods shall be
defined. Selection of auditors and the conduct of audits shall ensure the objectivity and impartiality of the audit process.
Auditors shall not audit their own work.
• The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records,
shall be defined in a documented procedure.
• The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate
detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the
reporting of the verification results.
For clause or sub-clause of the GFSI standard:
• Read the requirement - ask yourself – what do I need to measure – what is necessary to see/hear as
a measure of compliance
• Develop a strategy for determining compliance:
• Interviewing (knowledge of the required procedure
• Record Review – history of documented performance
• Visual Observation
• Follow audit trails
• Ensure you look on all production shifts and test back-up personnel
• Observe demonstrations of critical tasks
• Find a perch – observed personnel movements and actions
• Follow the process map – accuracy
• Try to find gaps, imperfections, anomalies
FSMA FRIDAYS
Conducting the Audit - Techniques
An independent verification of compliance
Confirm you do as you say you do
FSMA FRIDAYS
Internal Audit = Verification
Internal audit findings document:
• All documents analyzed, personnel interviewed with details both for compliance and non-
compliance clauses
• What was checked to make the determination of compliance or non-compliance – listing of
objective evidence
• Non-conformances are clearly stated, contain the objective evidence (what exactly was found?
exactly where?)
Senior management role:
• Senior Managers need to be involved in decisions and management of corrective actions through
this process.
FSMA FRIDAYS
Document Findings
FSMA FRIDAYS
Example Internal Audit (BRC – Food)
1. Senior Management Commitment Take Non Conformances to Corrective Action Reports – state “Internal Audit Finding”
1.1 Senior management commitment and continual improvement State what you reviewed, interviews completed, visual compliance etc.
FUNDAMENTAL
Statement of Intent
The company’s senior management shall demonstrate they are fully committed to the implementation of the requirements of the Global Standard for Food Safety and to
processes which facilitate continual improvement of food safety and quality management.
Requirement Y/N Auditor to Look For Finding
1.1.1 The company shall have a documented policy which
states the company’s intention to meet its obligation to
produce safe and legal products to the specified quality
and its responsibility to its customers. This shall be:
• signed by the person with overall responsibility for the
site
• communicated to all staff.
Y
Look for how the policies are communicated to staff
including details of dates and who sanctions the
policies.
Is the policy signed; posted in the office lunch room
and processing entrance?
Is it currently dated?
XX has in place a Food Safety Policy dated in
March 1, 2016. There have been no changes since
then requiring a revision, so is accepted. It is posted
in the reception hall and lunch room. Employees
interviewed (HB, VS) are aware of the policy.
July 26/18 JBW
Opening Meeting:
• Set the audit expectation,
• Introduce all auditors to the management and supervisory team
• Share the audit schedule
• Summarize the techniques to be used
• Detail the expectations for corrective actions
Closing Meeting:
• Thanks all participants
• Mention the good things seen
• Review non-conformances in detail
• Get commitment for completion dates that are reasonable and risk based
• Follow-up to completion
FSMA FRIDAYS
Opening & Closing Meeting
Q & A
FSMA FRIDAYS
Join us on LinkedIn
Connect and continue the
conversation on our
FSMA Fridays LinkedIn Group!
FSMA FRIDAYS
The Acheson Group
Need FSMA Help? TAG is Here to
Help!
Rules & Regulations
Personalized Consultations
Food Safety Plans
FDA Records
GFSI Compliance
Learn more at
AchesonGroup.com | 800-401-2239
FSMA FRIDAYS
SafetyChain Software
Food Quality Management System
Quality Assurance
Food Safety
Supplier Compliance
Learn more at SafetyChain.com
FSMA Friday Session Recording
SafetyChain Beyond Compliance Webinar Series
SafetyChain Demo Day
TAG Newsletter
FSMA FRIDAYS
Resources & Events
Join us next month April 26, 2019

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FSMA Friday Bonus - Completing Effective GFSI Internal Audits

  • 1. FSMA FRIDAYS The Latest Industry News, Updates & Trends March 2019
  • 2. MONTHLY INDUSTRY UPDATE FSMA Related News Regulation Changes & Updates Industry Trends Q&A with TAG FSMA FRIDAYS What is FSMA Fridays?
  • 4. FSMA FRIDAYS Agenda HELPFUL TIPS Informal but professional format Ask Questions (Q&A at end) Only panelists are displayed Recording link will be shared Audio issues: use call-in number WHAT WE WILL COVER Planning and Effective Internal Audit Internal Audit Basics Audience Q&A
  • 5. FSMA FRIDAYS Presenters Dave Detweiler Senior VP, Business Development Rich Simmons Senior Advisor, Food Safety Rolando Gonzalez, Ph.D. Vice President, Public Health
  • 7. Completing an Effective Internal Audit for GFSI Standards
  • 8. FSMA FRIDAYS Plan the Audit Conduct the Audit Documenting Findings Opening and Closing Meetings Follow-Up on Corrective Actions Defining the Internal Audit
  • 9. FSMA FRIDAYS Audit Content Using the GFSI Standard as a base of the audit Re-structuring the standard audit checklist Technical requirements needed – understanding the audit requirements  Audit Schedule GFSI programs are large and cover many areas of food safety management Just like a marathon – you must pace the audit activity to maximize effectiveness Pre-arrange and schedule interviews with managers Plan the internal audit over the year, if possible (a requirement of BRC Food Standard) Planning the Audit
  • 10. FSMA FRIDAYS FSM EII 11 The standard shall require that the organisation has an internal audit system in place to cover all activities within the scope of the Food Safety Management System. GFSI Audit Requirement
  • 11. FSMA FRIDAYS 2.5.5 Internal Audits and Inspections (Mandatory) 2.5.5.1 The methods and responsibility for scheduling and conducting internal audits to verify the effectiveness of the SQF System shall be documented and implemented. Internal audits shall be conducted at least annually. The methods applied shall ensure: • All applicable requirements of the SQF Food Safety Code for Manufacturing are audited as per the SQF audit checklist or similar tool; • Correction and corrective action of deficiencies identified during the internal audits are undertaken; • Audit results are communicated to relevant management personnel and staff responsible for implementing and verifying corrective actions. Safe Quality Food (SQF) Standard
  • 12. FSMA FRIDAYS FUNDAMENTALThe company shall be able to demonstrate that it verifies the effective application of the food safety plan and the implementation of the requirements of the Global Standard for Food Safety. 3.4.1 There shall be a scheduled programme of internal audits. At a minimum, the programme shall include at least four different audit dates spread throughout the year. The frequency at which each activity is audited shall be established in relation to the risks associated with the activity and previous audit performance. All activities shall be covered at least once each year. At a minimum, the scope of the internal audit programme shall include the: • HACCP or food safety plan, including the activities to implement it (e.g. supplier approval, corrective actions and verification) • prerequisite programmes (e.g. hygiene, pest control) • food defence and food fraud prevention plans • procedures implemented to achieve the Standard. Each internal audit within the programme shall have a defined scope and consider a specific activity or section of the HACCP or food safety plan. BRC Global Standard for Food Safety Issue 8
  • 14. 3.4.2 Internal audits shall be carried out by appropriately trained, competent auditors. Auditors shall be independent (e.g. not audit their own work). 3.4.3 The internal audit programme shall be fully implemented. Internal audit reports shall identify conformity as well as non-conformity and include objective evidence of the findings. The results shall be reported to the personnel responsible for the activity audited. Corrective and preventive actions, and timescales for their implementation, shall be agreed and their completion verified. FSMA FRIDAYS BRC Global Standard for Food Safety Issue 8
  • 15. FSMA FRIDAYS FSSC 22000:2018 • ISO 22000: 8.4 Food safety management system verification • 8.4.1 Internal audit • The organization shall conduct internal audits at planned intervals to determine whether the food safety management system • a) conforms to the planned arrangements, to the food safety management system requirements established by the organization, and to the requirements of this International Standard, and • b) is effectively implemented and updated. • An audit program shall be planned, taking into consideration the importance of the processes and areas to be audited, as well as any updating actions resulting from previous audits (see 8.5.2 and 5.8.2). criteria, scope, frequency and methods shall be defined. Selection of auditors and the conduct of audits shall ensure the objectivity and impartiality of the audit process. Auditors shall not audit their own work. • The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records, shall be defined in a documented procedure. • The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of the verification results.
  • 16. For clause or sub-clause of the GFSI standard: • Read the requirement - ask yourself – what do I need to measure – what is necessary to see/hear as a measure of compliance • Develop a strategy for determining compliance: • Interviewing (knowledge of the required procedure • Record Review – history of documented performance • Visual Observation • Follow audit trails • Ensure you look on all production shifts and test back-up personnel • Observe demonstrations of critical tasks • Find a perch – observed personnel movements and actions • Follow the process map – accuracy • Try to find gaps, imperfections, anomalies FSMA FRIDAYS Conducting the Audit - Techniques
  • 17. An independent verification of compliance Confirm you do as you say you do FSMA FRIDAYS Internal Audit = Verification
  • 18. Internal audit findings document: • All documents analyzed, personnel interviewed with details both for compliance and non- compliance clauses • What was checked to make the determination of compliance or non-compliance – listing of objective evidence • Non-conformances are clearly stated, contain the objective evidence (what exactly was found? exactly where?) Senior management role: • Senior Managers need to be involved in decisions and management of corrective actions through this process. FSMA FRIDAYS Document Findings
  • 19. FSMA FRIDAYS Example Internal Audit (BRC – Food) 1. Senior Management Commitment Take Non Conformances to Corrective Action Reports – state “Internal Audit Finding” 1.1 Senior management commitment and continual improvement State what you reviewed, interviews completed, visual compliance etc. FUNDAMENTAL Statement of Intent The company’s senior management shall demonstrate they are fully committed to the implementation of the requirements of the Global Standard for Food Safety and to processes which facilitate continual improvement of food safety and quality management. Requirement Y/N Auditor to Look For Finding 1.1.1 The company shall have a documented policy which states the company’s intention to meet its obligation to produce safe and legal products to the specified quality and its responsibility to its customers. This shall be: • signed by the person with overall responsibility for the site • communicated to all staff. Y Look for how the policies are communicated to staff including details of dates and who sanctions the policies. Is the policy signed; posted in the office lunch room and processing entrance? Is it currently dated? XX has in place a Food Safety Policy dated in March 1, 2016. There have been no changes since then requiring a revision, so is accepted. It is posted in the reception hall and lunch room. Employees interviewed (HB, VS) are aware of the policy. July 26/18 JBW
  • 20. Opening Meeting: • Set the audit expectation, • Introduce all auditors to the management and supervisory team • Share the audit schedule • Summarize the techniques to be used • Detail the expectations for corrective actions Closing Meeting: • Thanks all participants • Mention the good things seen • Review non-conformances in detail • Get commitment for completion dates that are reasonable and risk based • Follow-up to completion FSMA FRIDAYS Opening & Closing Meeting
  • 21. Q & A
  • 22. FSMA FRIDAYS Join us on LinkedIn Connect and continue the conversation on our FSMA Fridays LinkedIn Group!
  • 23. FSMA FRIDAYS The Acheson Group Need FSMA Help? TAG is Here to Help! Rules & Regulations Personalized Consultations Food Safety Plans FDA Records GFSI Compliance Learn more at AchesonGroup.com | 800-401-2239
  • 24. FSMA FRIDAYS SafetyChain Software Food Quality Management System Quality Assurance Food Safety Supplier Compliance Learn more at SafetyChain.com
  • 25. FSMA Friday Session Recording SafetyChain Beyond Compliance Webinar Series SafetyChain Demo Day TAG Newsletter FSMA FRIDAYS Resources & Events Join us next month April 26, 2019