Food Safety and Quality systems have a major impact on your business including regulatory compliance, risk mitigation and operational performance. For most food companies, the expectations are high, the risk is great, but it’s not getting any easier to balance these critical areas. In this session of our Beyond Compliance webinar and podcast series, Jeff Chilton (Vice President of Professional Services, Alchemy Systems) discusses smart, simple and realistic strategies that companies of any size can use to optimize their food safety and quality systems. Jeff provides insight from over 30 years of experience in the food industry specializing in food safety, quality assurance, and plant management.

1. Beyond Compliance
Webinar & Podcast Series
Balancing Compliance, Risk & Performance
Presented By: Jeff Chilton, Alchemy Systems

2. Beyond Compliance Webinar Series
The Series
Webinar & Podcast Series
BEYONDCOMPLIANCE

3. Beyond Compliance Webinar Series
The Sponsor
Food Quality Management System
Food Safety
Food Quality
Supplier Compliance
Learn more at SafetyChain.com

4. Beyond Compliance Webinar Series
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

5. TRAINING TOPIC

6. • Jeff Chilton
• VP Professional Services
Today’s Speaker
6

7. AGENDA
7
• Establishing Effective Foundations for FSQM Systems
• Assuring Regulatory Compliance and Audit Standards
• Best Practices to Mitigate Risks
• Optimizing FSQM Systems for Results
• Managing the FSQM System Effectively
• Resources
• Questions

8. 8
Effective Foundations for FSQM System

9. Effective Foundations for FSQM Systems
9
• Food Safety & Quality
Managements Systems require:
 Prerequisite Programs
 HACCP / Food Safety Plans
 Quality SOP’s (Standard
Operating Procedures)
 Quality CQP’s (Critical Quality
Points)
• Challenging to meet:
 Regulatory Requirements
 Audit Requirements
 Customer Requirements
 All while protecting your company
from a Product Recall and Foodborne
Illness Outbreak

10. Effective Foundations for FSQM Systems
10
• QA Team:
 Management Leadership
 Sufficient staff of QA Technicians
 Coverage for multiple shifts
 Promote positive food safety
culture with QA and Operations
working cooperatively
• Training for Competency:
 HACCP Training
 Preventive Control PCQI
 Internal Auditor
 Statistical Process Control
 Corrective and Preventive Action (CAPA)
 Root Cause Analysis
 Applies to QA, Food Safety Team and Ops
Managers

11. Challenges to Managing FSQM Systems
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• Inadequate sponsorship from Senior Management or Operations
• Inadequate staffing for QA Department
• Turnover and new QA personnel training
• Customer specifications and complaints
• Audit management
• Document Control management of procedures and forms
• Records management
• Regulatory agency interaction
• Product and environmental testing / Laboratory management

12. 12
Regulatory and Audit Compliance

13. Audit Compliance
13
• Challenges
1. Changing standards
2. Multiple audits
3. Unannounced audits
4. Code Requirements vs.
Guidelines Expectations
5. Time management
• Readiness Tips
1. Internal Audit Processes
2. Prerequisite Program
Verification / Validations
3. Audit Preparation Inspection
4. Audit Management Strategy
5. Advance Team Inspections
6. Management Commitment
and involvement

14. Regulatory Compliance
14
• Challenges
1. Understanding new regulations
2. Inspector interpretations
3. Rogue inspectors and retaliatory actions
4. Developing responses to enforcement actions (USDA NR’s or FDA 483’s)

15. Tips for Regulatory Compliance
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1. Complete training and know the regulations
2. Ask the inspector what specific regulation has been violated and how
3. Appeal when warranted
4. Present only the required information
5. Answer questions but don’t volunteer information
6. Control the inspection to the identified scope
7. Respond to the identified issues only with the corrective action taken and revised supporting
documentation

16. 16
Best Practices To Mitigate Risks

17. What type of risks are we referring to?
17
Pathogen
Contamination/
Foodborne Illness
Regulatory
Non-Compliance
Product Recalls

18. A New Approach with Enterprise Risk Management
• Strategic prioritization by function (comprehensive or by desired sections)
– Corporate
– Supply Chain
– Food Safety and Quality Systems
– Microbial Control
– Compliance
– Due diligence approach
• Corrective action and closure
• Risk Reassessments
• Executive view and reporting

19. What needs to be assessed? (All or Part)
SUPPLY CHAIN
Supplier Risk
Finished
Product
Micro
Environmental
Micro
Raw Material
Risk
sanitation
dEVIA
TIONS
Complaints
Non-Conforming
Product
REGULATORY
WARNINGS
Product Recall
Traceability
Allergens
Crisis
Management
Audit Management
Corporate/Culture
Food Safety Plan

20. Swab-A-Thon Challenge
• FDA focus on Control of Listeria Monocytogenes
• FDA Inspections – Broad Assessment PC Inspection (500) or Full Preventive Control Inspections
(140) to date
• Be proactive to challenge your own operation prior to regulatory actions
• Complete intensified swabbing of all 4 zones to assess effectiveness of Listeria Control Programs
• Be prepared to take corrective actions for positive results
• Improve your environmental control program with better targeted testing
• Manage your results with attorney-client privileges for confidentiality

21. 21
Optimizing FSQM Systems for Results

22. Optimizing Your FSQM System
22
• Follow your HACCP or Food Safety Plan to assure food safety controls
• Verify and Validate the food safety system with thorough reassessments
• Establish a Quality Process Control System based on HACCP methodology
• Use existing Product Descriptions and Flow Charts
• Complete a Quality Risk Analysis to assess threats and identify Critical Quality Points (CQP’s)
• For CQP’s, identify operating limits, monitoring, corrective action, verification and record
keeping procedures (Similar to the SQF Food Quality Plan but focused on CQP’s for
performance correlated with specifications)

23. Optimizing Your FSQM System
23
• Tips
– Realistic Product Specifications
– Document the Quality Process
Control Plan
– Execute the plan to improve
product consistency and yields
– Automate systems
– Measure results
• Benefits
– Reduced out of specification
product on hold
– Increased product yields from less
rework and condemned product
– Reduced need for CAPA’s and RCA’s
– Reduced time and labor for record
keeping
– Manage FSQM system, audits and
results electronically

24. 24
Managing the FSQM System Effectively

25. Food Safety and Quality System Metrics Overview
25
• Suppliers should set objectives for their food safety and quality systems with
measurable metrics and specific goals
• Objectives should be routinely measured against goals to assess the performance of
the food safety and quality systems
– Recommended monthly or quarterly – no less than annually
• Results and trends should be analyzed to identify continuous improvement
opportunities for the food safety and quality management system

26. Food Safety and Quality System Metrics Overview
26
• Recalls – zero tolerance goal!
• Audit results – passing within top two scoring tiers
• External and internal audit non-conformances identified – quantity and trends
• Customer Complaints – based on % targeted improvement over baseline results
• Non-Conforming Product - # incidents and based on % targeted improvement over
baseline results
• CCP Deviation History - # of deviations

27. Food Safety and Quality System Metrics Overview
27
• USDA NR’s Non-Compliance Records – quantity and % targeted improvement over
baseline results
• Vendor Non-Conformances - # of incidents, trend analysis and % targeted improvement
over baseline results
• SSOP Results – number of pre-operational and operational sanitation deficiencies, based
on % targeted improvement over baseline results
• Microbiological Results – finished product testing % compliance within specification;
food contact surface and environmental testing & compliance with goals
• Corrective Action Results - # incidents and effectiveness evaluation to prevent recurring
deficiencies

28. FSQM System Management Reviews
28
• Management reviews of the results should be completed at least quarterly
• Food Safety Team and senior management should participate in the reviews
• Consider inputs of results and necessary outputs to address problem areas
and drive continuous improvements

29. Food Safety & Quality System Automation
29
• QA departments manage huge volumes of information related to supply chain
management, written programs, records, and microbiological results
• Paper records can be replaced with electronic records
• It is highly recommended that you electronically automate food safety and
quality systems with software that manages the processes such as Safety Chain
• Trend analysis of results can be completed to drive continuous improvement

30. 30
RESOURCES

31. Resource: Alchemy Consulting Services
31
Training
HARPC Workshop based on
FDA recognized
standardized curriculum
• Public courses or on-site
• On-line courses coming
soon
Gap Analysis
• On site review to evaluate
existing programs,
products and facility to
new regulatory
requirements
• Off site desk top review of
existing HACCP Plans
comparison to new
regulatory requirements
Development
Creation of new Food Safety
Plan documentation
customized for your products
and processes
Reanalysis
• Desk top review of client
created Food Safety Plan
• On Site Reanalysis to
validate food safety
system and written
program compliance

32. 32
• Accredited by the International HACCP Alliance
• Receive a certificate of completion
• Teaches you how to develop & implement an effective
Food Safety Plan based on CODEX HACCP specifications,
which is required by the four major GFSI schemes
– SQF, BRC, FSSC 22000, and IFS
Learn more at: https://academy.alchemysystems.com/basic-haccp-course/
NEW! Basic HACCP eLearning Course

33. FSMA Preventive Controls for Human Food Training
In-Person Classroom Course
Get hands-on access to experts with 200+ years of experience
Austin, TX
2018 Classroom Dates
May 15-17
Learn here:
https://academy.alchemysystems.com/product/preventive-control-for-
human-food-in-person-course/

34. Alchemy’s Employee Engagement Solutions
34
• Educate your employees with multilingual training courses
• Keep fundamentals top-of-mind with huddle guides and signage
• Drive continuous improvement with an on-the-job coaching app
• Stay audit-ready with automatic documentation and real-time reporting

35. Q & A

36. Resources
White Papers & Surveys
Webinars & Videos
Product & Partner Info
Solution Consultation
info@safetychain.comSafetyChain.com