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Title: The Magic of Internal Audits: Mistakes, Insights and Advice from the Experts
Presented By: Jeff Strout, MPH, Mérieux NutriSciences
Beyond Compliance
Webinar & Podcast Series
SafetyChain.com
The Series
Webinar & Podcast Series
BEYONDCOMPLIANCE
Beyond Compliance Webinar Series
Beyond Compliance Webinar Series SafetyChain.com
The Sponsor
Food Quality Management System
✔Food Safety
✔Food Quality
✔Supplier Compliance
Learn more at SafetyChain.com
SafetyChain.com
Before We Get Started
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
Beyond Compliance Webinar Series
TRAINING TOPIC
The Magic of Internal Audits: Mistakes,
Insights and Advice from the Experts
Presented By: Jeff Strout, MPH, Mérieux NutriSciences
ABOUT THE SPEAKER Jeff Strout, MPH, RS/REHS, CQA, CHA, CP-FS
Former SQFI Trainer of the Year
• Acclaimed FSQA educator and consultant who delivers
public, private, and customized short courses, globally
• Performed over 7,000 food safety and quality audits in the
past 38 years
Jeff’s Areas of Expertise Include:
• Food Safety and Sanitation Audits
• HACCP Development and Training
• SQF, Sanitation, Laboratory and QA Training
• Root Cause Analysis
• Food Defense
• Crisis Management
• Preventive Controls for both Human and Animal Food
Jeffrey Strout
Agenda
1. Internal Audits – need and coverage
2. Selecting and training auditors
3. Mistakes
4. Managing the internal audit system
5. Advice and tips
6. Best practices
➔ Basic Guidelines for Auditing Management Systems
◆ Principles of Auditing
◆ Establishing, implementing, monitoring and reviewing audit programs
◆ Performing an audit
◆ Audit Reporting
◆ Follow-up
◆ Auditor Competence (Initial determination, maintaining and improving)
◆ Auditor Evaluations
ISO Standard 19011:2018
8
1. Need for Internal Auditing/Coverage
9
DRIVERS
Customers
Regulatory
Expectations
GFSI
Moral
Obligation
Effective
Management
Prevent
Illness and
Recall
➔ Food Safety – HACCP – Preventive Control Plans
◆ Critical Control Points/Preventive Controls
➔ Food Quality Systems
➔ Packaging Systems
➔ People
◆ People Practices
➔ Calibration
➔ Sanitation
➔ Approved Supplier
1. Need for Internal Auditing/Coverage
10
➔ Maintenance
➔ Water Safety and Quality
➔ Stock Rotation
➔ Pest Control
➔ Foreign Material Control
➔ Allergen Management
➔ Business Continuity-Crisis Mgt
➔ Food Defense
➔ Product ID, Trace and Recall
➔ Transportation
➔ Training
➔ Waste Management
1. Need for Internal Auditing/Coverage
11
2a. Audit Team
➔Can be a team of individuals from different departments
◆ Operations
◆ Maintenance
◆ Quality Assurance
◆ Warehouse
◆ Shipping/Receiving
◆ Human Resources
◆ Others?
12
2b. Team Responsibilities
➔Audit Areas Independent of their Area of Responsibility
➔Be Trained on Criteria
➔Be Trained on Auditing Procedures
◆ Thorough Preparation
◆ Proper and Effective Execution
◆ Company Reporting Requirements
◆ Follow-Up (If applicable)
13
2c. Auditor Selection
Auditor
Knowledge
Plant
Operations
Criteria or
Requirements
Hazards
2d. Auditor Skills
Integrity Sincerity Trustworthy
Ethical Fair
Open-minded,
flexible
2e. Auditor Skills
Diplomatic Observant Versatile Tenacious
Decisive Self-reliant Unbiased Sympathetic
2f. Professionalism
➔ Appearance
➔ Punctuality
➔ Manners
➔ Preparedness
➔ Effort and Time
➔ Focus on Audit, Not Work
2g. Selecting the Right Auditor
➔ Keep Confidentiality
➔ No Conflict of Interest
➔ No Unsafe Activities
➔ No Unethical Activities
◆ Bribes
◆ Favors
◆ Bias
➔ Observation of Unethical Behaviors
➔ Not assigning dollar value to findings (preventive costs, repair costs and
recall costs if nothing is done)
➔ Not having the right frequency of audits
➔ Not training (orientation or refresher) auditors
➔ Not having all criteria included in the audit
➔ Not reporting positive findings
➔ Not reporting preventive actions needed
3. Mistakes
19
➔ Not reporting “Best Practices” found
➔ Not reporting on the “WOW FACTOR” for each area and products
➔ Not reporting all requirements for negative findings
◆ Laws (Local, State and Federal as well as other countries sold to)
◆ GFSI requirements
◆ Internal Company
◆ Customer
➔ Not focusing on the audit – working on normal job instead
3. Mistakes
20
➔ Not selecting the right auditors
➔ Not having SMART objectives for the audit
➔ Not auditing all essential areas
➔ Not taking findings seriously
➔ Not having an evaluation system for internal auditors
3. Mistakes
21
4a. Internal Audit Management System
22
Establishing Audit Objectives
Assign Competent Managers (roles, responsibilities)
Establish Audit Procedures and Methods to Meet Objectives
Establish Audit Criteria (Everything including the “Wow
Factor”)
Select and Organize Audit Teams
Process for Confidentiality, Security, Health and Safety
➔Extent of Audit Program
➔Audit Risks for Failure
➔Audit Program Resources
◆ Time
◆ Budget
◆ Information Availability
➔Audit Reporting System
4b. Establishing
23
4c. Maintaining the Program
◆ Team Assignment
● Right Mix
● Right Background
● Technical Experts (If needed)
◆ Auditor Skills and Competency
◆ Auditor Evaluation
◆ Criteria Current and Complete
● Updates
Annual Review
4d. Maintaining the Audit System
25
◆ Auditor behaviors and skills
◆ Audit principles, procedures and methods
◆ Knowledge and skills about the business and industry
◆ Legal and contractual requirements for auditing
◆ Sector specific knowledge
◆ Hazard risks for sector and product
Auditor Competency and Evaluation
4d. Maintaining the Audit System
26
◆ Establish Formal Education and Experience
● Audit Protocols and Procedures
● Auditor Skills
● Risks and Hazards
● Judgment, critical thinking, decision making, problem solving and
communication skills
Improving Auditor Competence
4e. Maintaining the Program
27
◆ Process
◆ Suppliers
◆ Packaging
◆ Ingredients/Processing Aids
◆ Products
Changes to the System
New Customers or Suppliers
4e. Maintaining the Program
28
Co-Manufacturers
• Environment
• People/Training
• Shifts or Work Times
Changes to…
4e. Maintaining the Program
29
◆Report Review (Adequacy)
◆Root Cause, Corrective and Preventive Actions Review
◆Distribution of Reports
◆Determination of Follow-up Actions
◆Retention of Audit Records
Managing Outcomes of Audit
Monitoring and Improving the Audit Program
4f. Audit Frequency
➔ Hybrid Audit
◆ Parts Performed Monthly (GMP Portion)
◆ Parts Performed Quarterly (Pre-requisite Programs)
◆ Parts Performed Semi-annually (Systems Related)
30
➔ Have a pool of auditors from many departments available for internal
audits and rotate their use so not everyone has to audit each time one is
needed
➔ Shift focus on audit to more positive findings (what we are doing right) –
more positive stories get more positive findings – more people will “step up
their game”
➔ Shift focus of audit to preventive actions and not just corrective actions
➔ Determine value of preventing problems (cost of preventive actions) and
put on report
➔ Determine cost of corrective actions for problems needing fixing and put
on report
5. Advice and Tips
31
➔ Determine a recall cost for problems where a corrective action not
completed might result in a contaminated product being shipped out and a
need to recall the items and put costs on report
➔ Add food safety and quality working culture on the internal audit to help
determine if the workplace culture is moving towards a safer, higher quality
working culture
➔ Establish specific objectives of what you want to accomplish with the
performance of the internal audits (are they integrated with the company
objectives and mission?)
➔ Establish a budget for internal audits to cover costs for training, swabbing
(if performed), equipment, software, etc.
5. Advice and Tips
32
➔ Select and formally train internal audit manager and team together
➔ Have strong opening meeting and closing meeting for each internal audit
➔ Brief everyone on the importance of the internal audit and to have
everyone share the “good, bad and the ugly” and all dirty laundry so to
speak so auditors can evaluate risks and offer corrective actions –
consulting is encouraged during the internal audit
➔ Celebrate the positive stories and findings and the preventive actions
6. Best Practices
33
➔ Help determine the “Wow Factor” for each product and each line…and
measure movement towards that factor
6. Best Practices
34
➔Mérieux Internal Auditing Course Held in Chicago
◆March 10-11, 2020
◆https://education.mxns.com/events/internal-auditing-in-a-food-plant-3/
So much information …
35
To Contact Today’s Presenter:
Jeff.Strout@mxns.com
Q & A
Resources
White Papers & Surveys
Webinars & Videos
Product & Partner Info
Solution Consultation
info@safetychain.com SafetyChain.com

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The Magic of Internal Audits: Mistakes, Insights and Advice from the Experts

  • 1. Title: The Magic of Internal Audits: Mistakes, Insights and Advice from the Experts Presented By: Jeff Strout, MPH, Mérieux NutriSciences Beyond Compliance Webinar & Podcast Series
  • 2. SafetyChain.com The Series Webinar & Podcast Series BEYONDCOMPLIANCE Beyond Compliance Webinar Series
  • 3. Beyond Compliance Webinar Series SafetyChain.com The Sponsor Food Quality Management System ✔Food Safety ✔Food Quality ✔Supplier Compliance Learn more at SafetyChain.com
  • 4. SafetyChain.com Before We Get Started 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 Beyond Compliance Webinar Series
  • 5. TRAINING TOPIC The Magic of Internal Audits: Mistakes, Insights and Advice from the Experts Presented By: Jeff Strout, MPH, Mérieux NutriSciences
  • 6. ABOUT THE SPEAKER Jeff Strout, MPH, RS/REHS, CQA, CHA, CP-FS Former SQFI Trainer of the Year • Acclaimed FSQA educator and consultant who delivers public, private, and customized short courses, globally • Performed over 7,000 food safety and quality audits in the past 38 years Jeff’s Areas of Expertise Include: • Food Safety and Sanitation Audits • HACCP Development and Training • SQF, Sanitation, Laboratory and QA Training • Root Cause Analysis • Food Defense • Crisis Management • Preventive Controls for both Human and Animal Food Jeffrey Strout
  • 7. Agenda 1. Internal Audits – need and coverage 2. Selecting and training auditors 3. Mistakes 4. Managing the internal audit system 5. Advice and tips 6. Best practices
  • 8. ➔ Basic Guidelines for Auditing Management Systems ◆ Principles of Auditing ◆ Establishing, implementing, monitoring and reviewing audit programs ◆ Performing an audit ◆ Audit Reporting ◆ Follow-up ◆ Auditor Competence (Initial determination, maintaining and improving) ◆ Auditor Evaluations ISO Standard 19011:2018 8
  • 9. 1. Need for Internal Auditing/Coverage 9 DRIVERS Customers Regulatory Expectations GFSI Moral Obligation Effective Management Prevent Illness and Recall
  • 10. ➔ Food Safety – HACCP – Preventive Control Plans ◆ Critical Control Points/Preventive Controls ➔ Food Quality Systems ➔ Packaging Systems ➔ People ◆ People Practices ➔ Calibration ➔ Sanitation ➔ Approved Supplier 1. Need for Internal Auditing/Coverage 10
  • 11. ➔ Maintenance ➔ Water Safety and Quality ➔ Stock Rotation ➔ Pest Control ➔ Foreign Material Control ➔ Allergen Management ➔ Business Continuity-Crisis Mgt ➔ Food Defense ➔ Product ID, Trace and Recall ➔ Transportation ➔ Training ➔ Waste Management 1. Need for Internal Auditing/Coverage 11
  • 12. 2a. Audit Team ➔Can be a team of individuals from different departments ◆ Operations ◆ Maintenance ◆ Quality Assurance ◆ Warehouse ◆ Shipping/Receiving ◆ Human Resources ◆ Others? 12
  • 13. 2b. Team Responsibilities ➔Audit Areas Independent of their Area of Responsibility ➔Be Trained on Criteria ➔Be Trained on Auditing Procedures ◆ Thorough Preparation ◆ Proper and Effective Execution ◆ Company Reporting Requirements ◆ Follow-Up (If applicable) 13
  • 15. 2d. Auditor Skills Integrity Sincerity Trustworthy Ethical Fair Open-minded, flexible
  • 16. 2e. Auditor Skills Diplomatic Observant Versatile Tenacious Decisive Self-reliant Unbiased Sympathetic
  • 17. 2f. Professionalism ➔ Appearance ➔ Punctuality ➔ Manners ➔ Preparedness ➔ Effort and Time ➔ Focus on Audit, Not Work
  • 18. 2g. Selecting the Right Auditor ➔ Keep Confidentiality ➔ No Conflict of Interest ➔ No Unsafe Activities ➔ No Unethical Activities ◆ Bribes ◆ Favors ◆ Bias ➔ Observation of Unethical Behaviors
  • 19. ➔ Not assigning dollar value to findings (preventive costs, repair costs and recall costs if nothing is done) ➔ Not having the right frequency of audits ➔ Not training (orientation or refresher) auditors ➔ Not having all criteria included in the audit ➔ Not reporting positive findings ➔ Not reporting preventive actions needed 3. Mistakes 19
  • 20. ➔ Not reporting “Best Practices” found ➔ Not reporting on the “WOW FACTOR” for each area and products ➔ Not reporting all requirements for negative findings ◆ Laws (Local, State and Federal as well as other countries sold to) ◆ GFSI requirements ◆ Internal Company ◆ Customer ➔ Not focusing on the audit – working on normal job instead 3. Mistakes 20
  • 21. ➔ Not selecting the right auditors ➔ Not having SMART objectives for the audit ➔ Not auditing all essential areas ➔ Not taking findings seriously ➔ Not having an evaluation system for internal auditors 3. Mistakes 21
  • 22. 4a. Internal Audit Management System 22 Establishing Audit Objectives Assign Competent Managers (roles, responsibilities) Establish Audit Procedures and Methods to Meet Objectives Establish Audit Criteria (Everything including the “Wow Factor”) Select and Organize Audit Teams Process for Confidentiality, Security, Health and Safety
  • 23. ➔Extent of Audit Program ➔Audit Risks for Failure ➔Audit Program Resources ◆ Time ◆ Budget ◆ Information Availability ➔Audit Reporting System 4b. Establishing 23
  • 24. 4c. Maintaining the Program ◆ Team Assignment ● Right Mix ● Right Background ● Technical Experts (If needed) ◆ Auditor Skills and Competency ◆ Auditor Evaluation ◆ Criteria Current and Complete ● Updates Annual Review
  • 25. 4d. Maintaining the Audit System 25 ◆ Auditor behaviors and skills ◆ Audit principles, procedures and methods ◆ Knowledge and skills about the business and industry ◆ Legal and contractual requirements for auditing ◆ Sector specific knowledge ◆ Hazard risks for sector and product Auditor Competency and Evaluation
  • 26. 4d. Maintaining the Audit System 26 ◆ Establish Formal Education and Experience ● Audit Protocols and Procedures ● Auditor Skills ● Risks and Hazards ● Judgment, critical thinking, decision making, problem solving and communication skills Improving Auditor Competence
  • 27. 4e. Maintaining the Program 27 ◆ Process ◆ Suppliers ◆ Packaging ◆ Ingredients/Processing Aids ◆ Products Changes to the System New Customers or Suppliers
  • 28. 4e. Maintaining the Program 28 Co-Manufacturers • Environment • People/Training • Shifts or Work Times Changes to…
  • 29. 4e. Maintaining the Program 29 ◆Report Review (Adequacy) ◆Root Cause, Corrective and Preventive Actions Review ◆Distribution of Reports ◆Determination of Follow-up Actions ◆Retention of Audit Records Managing Outcomes of Audit Monitoring and Improving the Audit Program
  • 30. 4f. Audit Frequency ➔ Hybrid Audit ◆ Parts Performed Monthly (GMP Portion) ◆ Parts Performed Quarterly (Pre-requisite Programs) ◆ Parts Performed Semi-annually (Systems Related) 30
  • 31. ➔ Have a pool of auditors from many departments available for internal audits and rotate their use so not everyone has to audit each time one is needed ➔ Shift focus on audit to more positive findings (what we are doing right) – more positive stories get more positive findings – more people will “step up their game” ➔ Shift focus of audit to preventive actions and not just corrective actions ➔ Determine value of preventing problems (cost of preventive actions) and put on report ➔ Determine cost of corrective actions for problems needing fixing and put on report 5. Advice and Tips 31
  • 32. ➔ Determine a recall cost for problems where a corrective action not completed might result in a contaminated product being shipped out and a need to recall the items and put costs on report ➔ Add food safety and quality working culture on the internal audit to help determine if the workplace culture is moving towards a safer, higher quality working culture ➔ Establish specific objectives of what you want to accomplish with the performance of the internal audits (are they integrated with the company objectives and mission?) ➔ Establish a budget for internal audits to cover costs for training, swabbing (if performed), equipment, software, etc. 5. Advice and Tips 32
  • 33. ➔ Select and formally train internal audit manager and team together ➔ Have strong opening meeting and closing meeting for each internal audit ➔ Brief everyone on the importance of the internal audit and to have everyone share the “good, bad and the ugly” and all dirty laundry so to speak so auditors can evaluate risks and offer corrective actions – consulting is encouraged during the internal audit ➔ Celebrate the positive stories and findings and the preventive actions 6. Best Practices 33
  • 34. ➔ Help determine the “Wow Factor” for each product and each line…and measure movement towards that factor 6. Best Practices 34
  • 35. ➔Mérieux Internal Auditing Course Held in Chicago ◆March 10-11, 2020 ◆https://education.mxns.com/events/internal-auditing-in-a-food-plant-3/ So much information … 35 To Contact Today’s Presenter: Jeff.Strout@mxns.com
  • 36. Q & A
  • 37. Resources White Papers & Surveys Webinars & Videos Product & Partner Info Solution Consultation info@safetychain.com SafetyChain.com