Inside the Mind of a Food Safety Auditor
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Transcript of Inside the Mind of a Food Safety Auditor
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Inside the Mind of a Food Safety Auditor
Lessons Learned in Food Safety & Quality
Nancy Scharlach, President & Chief Technical DirectorSoterian Systems, LLC
andGary Nowacki, CEO
TraceGains, Inc.
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Gary NowackiCEOTraceGains
Nancy ScharlachPresident & Chief Technical DirectorSoterian Systems, LLC
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Audit StoriesThrough the Eyes of an Auditor
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Learning Objectives • Focusing on the key areas to help improve or pass a re-cert,
unannounced, or even a first-time audit.• Anticipate and practice what auditors may ask during an audit.• Ensure the suppliers’ food safety plan aligns with the day-to-day
operations.• Real life food safety - how facilities can demonstrate to auditors and
customers the right practices, culture, and infrastructure in the processing areas and building.
• Examples of the good, the bad, and the ugly.
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Supplier Expectations1. Food Safety Management Systems (FSMS)2. HACCP & HARPC 3. Records & Record-keeping 4. Preparing Your Employees for Auditor Interactions5. Facility, Equipment, and Cultural Compliance regarding
Food Safety
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1. Food Safety Management Systems• Quality and Food Safety Manuals• Management Commitment and Company Policies• Standard Operating Procedures (SOP’s)• Work Instructions• Org. Charts, Job Descriptions, Crisis Teams, etc. • Food Safety Preventative Controls (HACCP/HARPC)
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2. HACCP & HARPC ComparisonHACCP
Hazard Analysis Critical Control Point
• HACCP is a global standard (Codex & NACMCF), developed by private industry and engineers; Army Labs & Pillsbury in 1959.
• Has evolved and is now integrated into all GFSI and audit scheme requirements.
• Follows the seven (7) principles to identify and control food safety hazards in a processing facility.
• Is a preventative approach to controlling food safety hazards.
HARPCHazard Analysis Risk-Based Preventative Controls
• HARPC was developed by the FDA (US standard) and incorporated into the FSMA on July 4, 2012.
• Applies to almost all food-processing facilities with exception to: Produce Safety Standards, Regulatory HACCP (Meat/Poultry, Seafood and Juice), GMP for Dietary Supplements and small/very small businesses (further defined by FDA). (http://sustainableagriculture.net/fsma/learn-about-the-issues/definition-of-very-small-business-preventive-controls-rule/)
• Requires preventative controls and also requires planning for potential terrorists acts, intentional adulteration and food fraud.
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3. Records and Record-keeping• Approximately 60% of audits are spent on SOP’s/Manuals, and
Records; day-to day, CCP’s, Supplier Management/Performance, training, CAPA’s, team meetings, internal audits, etc.
• If a non-conformance is noted with records, or if corrective action records (CAPA) are not completed, auditors will then look for trends; this can lead to a systematic breakdown (and a more difficult audit…)
• Weaknesses with record-keeping include:• Lack of ongoing Employee Training• Lack of ‘Tools’ to capture information• Incorrect Information/Values on Forms• Lack of Sign Offs and Verification Protocols
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3. Records and Record-keeping (cont’d)• HACCP/HARPC Plan(s)• CCP’s, CQP’s (SQF Level III)• Processing Records• Commercialization Activities• Receiving & Shipping• Supplier Management• Internal Audits• Employee Training
• Crisis Team Exercises• Business Continuity Training• System Verification• Validation Methods and Actions• Traceability and Recall Protocols,
etc.
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4. Preparing Your EmployeesWho do auditors interview?• ANYONE in the facility! (and key office positions) • I have seen all positions interviewed from Warehouse, Processing, all
types of CCP Operators, Sorters, Packers, Labeling, Maintenance, Sanitation, QA Techs, R&D, Supply Chain, and even Senior Management.
• Auditors expect all employees in the facility to know key information regarding food safety and their audit code.
• No one is exempt from interviews, it will just depend on the auditor’s choice.
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4. Preparing Your EmployeesWhat should I expect from an audit interview?• Auditors are trained to be professional, ethical and courteous when
conducting audits and interviews.• They are also required to interview employees to ensure:
• Proper Employee Training has been implemented• Management Commitment is evident and proper resources are allocated to
support the food safety program• Adequate information has been trained to all employees in the facility• Key positions have completed additional training topics related to their job
skills or requirements• Auditors are looking for evidence that the supplier has fully prepared
employees to follow GMP’s, food safety practices and their specific audit code basic information. Ex: SQF vs. BRC
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4. Preparing Your Employees (cont’d)Common questions from auditors…
• Where is the Food Safety Manual stored? • What do you do if you see a mouse? • What allergens are in ‘your’ facility? • Give me three examples of Personal Hygiene? • Give me examples of when you wash your hands? • How often should you change your company shirt/smock? • How long do you wash your hands for? • Why is nail polish not allowed? • Why do you not wear perfume/cologne? • What is ‘your companies’ CCP(s)?: (Critical Control Point)• What does SQF stand for? (or BRC, etc.)
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4. Preparing Your Employees (cont’d)How do you prepare employees?• TRAINING! • There is no substitute for a comprehensive, documented employee
training program. • Methods can include fun exercises (ex. ‘GMP Jeopardy’), videos, live
classroom training with pictures, incentives, and prizes. • Training must be ongoing and well documented to ensure evidence for
the auditor. • Auditors will know how well training is done by the interview results.
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5. Facility, Equipment & Cultural Compliance• The facility, equipment and employee/company cultural drive the visual
evidence of how an auditor views or ‘sizes up’ the dedication and commitment to food safety
• Auditors will generally try and do a facility walk-through within the first 90 minutes of arriving to assess the condition of the facility and hygiene practices. (Unannounced is 60 minute window)
• Suppliers that operate under hygienic conditions; high grade equipment, building construction and employee practices will earn more ‘initial respect’ from auditor
• The auditor’s first impression is relevant
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Real Life Examples of Facility, Equipment and Employee Practices…
The Good…• Facilities that operate with high standards, best practices and GMP’s,
and instill a culture of “World Class Food Safety Practices”The Bad…• Examples of common minor non-conformities• Can be avoided if ongoing training and compliance is transcends from
Senior Management through all departments and employees The Ugly…• Examples of facilities that had critical non-conformances where
automatic failures occurred • The evidence indicates no real commitment to true food safety and
direct product adulteration was evident
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The Good…
Clean, organized processing environment.
High grade stainless steel, no rusting, etc. Good PM’s, sanitation protocols, employee practices, etc.
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DOs and DON’Ts
Good: Blue buffer tray separates food contact container from wood pallets
Bad: No color buffer tray, food contact container is in direct contact with wood pallet
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Common Non-conforming Practices
Hoses directly on the floor… Visible light…
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Common Non-conforming Practices (cont.)
Use of tape is prohibited (some exceptions using approved tape and registers with locations and usages)
Make-shift repairs, tape, condensation and rusting = multiple issues.
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The Ugly…Poorly maintained building conditions
Rusting sludge in the processing area, pathogen harborage sites, environmental nightmare for food processing.
Air ventilation in the processing area, pathogen harborage sites that can become airborne.
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The Truly Ugly…Direct product contact = Critical Non-conformances/Audit Failures *Potential adulteration of the product stream
Rusting, rotting food contact/handling table in processing room.
Rotting conveyor belt on active processing line, unidentifiable substances coming in contact with food (biofilms, sludge, etc.)
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The Truly Ugly…Direct product contact = Critical Non-conformances/Audit Failures *Potential adulteration of the product stream
Rusting niche areas with direct food contact surfaces…pathogen harborage sites
Condensation dripping directly onto product in cooler…product adulteration
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Creating a ‘culture’ for food safety
Employees using food contact tubs to stand on = direct adulteration
No training or enforcing with respect to GMP’s, hygiene or food contact equipment. (standing on tubs = standing on a conveyor belt in use, there is no difference)
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Summary…• Auditors look for and require adequate:
oFood Safety/Quality Manuals (SOP’s/Procedures)oRecords and Record-keeping practicesoSenior Management CommitmentoEmployee Training and Company Culture towards food safety
oBuilding, Equipment, and Best Practices in Operations
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Automating Supplier and
Quality Management
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TraceGains Products
Specification Publishing
Create, maintain, and publish your company’s unique specifications to ensure compliance on incoming ingredients.
Supplier Compliance
Automate lot-by-lot compliance across purchasing, COAs,
receiving, testing, and plant floor.
Finished Goods COAs
Generate finished goods COAs, manage
customer-specific formats, and send to
customers on demand.
Supplier Management
Automatically manage supplier qualification,
documents, and relationships.
Quality Management
Automate HACCP / HARPC and comply with GFSI, FSMA, safety, and quality.
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Supplier Analysis& Scorecarding
TraceGains Supplier Management
To-do Lists,Corrective Actions
Access Anywhere,Anytime
Allergens OrganicAudits KosherNutritionSupplier Qualification
FSMA, GFSI, 365 Audit Ready™
C.O.O.L. Specifications
24/7 Monitoring
eNotifications
Labeling(e.g., Genesis)
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TraceGains Quality Management
To-do Lists, Alerts,Corrective Actions
Trends & Graphs
Access Anywhere,Anytime
CCPsPre-op Sanitize, Calibrate, etc.
Verify CCPs Automate FSMA, GFSI Audits & Records
GFSI Documents
FSMA, GFSI, 365 Audit Ready™
Pre-ShipmentCheckoff
Staff Training
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Automation Solves Many Problems
GFSI
Labeling
FSMA
Audits
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Gary [email protected]
720-465-9400www.tracegains.com
Nancy [email protected]
303-593-2757www.soteriansystems.com