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.

Gary NowackiCEOTraceGains

Nancy ScharlachPresident & Chief Technical DirectorSoterian Systems, LLC

Audit StoriesThrough the Eyes of an Auditor

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.

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

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)

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.

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

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.

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.

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

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.)

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.

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

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

The Good…

Clean, organized processing environment.

High grade stainless steel, no rusting, etc. Good PM’s, sanitation protocols, employee practices, etc.

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

Common Non-conforming Practices

Hoses directly on the floor… Visible light…

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.

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.

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.)

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

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)

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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Gary Nowackigary.nowacki@tracegains.com

720-465-9400www.tracegains.com

Nancy Scharlachnancy@soteriansystems.com

303-593-2757www.soteriansystems.com