staying ahead of the audit curve with internal audits
TRANSCRIPT
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Staying Ahead of the Audit Curve With Internal Audits
Jeff Chilton, VP Professional ServicesSeptember 8, 2016
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Agenda• Audit cultures• Types of internal audits• Conducting the audit• Reporting the audit• Corrective actions and learnings• Best practices to eliminate audit gaps• Improving internal audit processes• Connecting the dots to make it all work• Conclusion
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Audit Cultures
Fire Fighter / ProcrastinatorCompliance Focused
• Always fighting problems• Ineffective corrective actions• Root cause not addressed• Scrambling at the last minute• Dog and pony show for the day
• Get by until the next one
Audit Ready 24/7Performance Focused
• Systems work effectively• Robust internal audit system• Root cause analysis corrective actions
• No fear of third party or unannounced audits
• Ready at any time
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Audit Cultures
• Animal welfare demands we stay audit ready 24/7
• The same expectations should be set for the remainder of our food safety and quality systems
• Challenge –– Target continuous improvement in
your internal auditing systems and preparation for third party audits
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Types of Internal Audits
5
GFSI System Audits
• SQF, BRC, FSSC 22,000
• Audit checklist
• Annual frequency divided into sections monthly or quarterly
• Internal system audit
• External 3rd party audit
• SQF, BRC, FSSC 22,000
• Audit checklist
• Annual frequency divided into sections monthly or quarterly
• Internal system audit
• External 3rd party audit
GMP / Plant Inspections
• GMP compliance inspections
• Facility inspections
• Typically monthly frequency to cover entire facility
• GMP compliance inspections
• Facility inspections
• Typically monthly frequency to cover entire facility
Process Audits
• Selection of a specific finished product lot
• Audit of all inputs, processes and outputs
• Specific process audits such as animal welfare, antimicrobial interventions
• Risk based frequency
• Selection of a specific finished product lot
• Audit of all inputs, processes and outputs
• Specific process audits such as animal welfare, antimicrobial interventions
• Risk based frequency
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Internal Audit Elements
• People • Equipment• Environments
• Materials • Measures• Methods
InputsInputs Process Steps
Process Steps OutputsOutputs Finished
ProductFinished Product
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
ISO 19011
Guidelines for quality and/or environmental management systems auditing
• Clear explanation of the principles of management system auditing
• Guidance on the management of audit programs• Guidance on the conduct of internal or external audit• Advice on the competence and evaluation of auditors
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Audit Team Members
• Must be trained on internal audit techniques to know what to look for during the internal audit process
• Must be assigned areas that are independent of their direct area of responsibility to avoid bias and offer a fresh perspective
• Must be familiar with how to identify deficiencies, report findings and follow up to assure effective corrective actions are taken
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Developing an Audit Plan/Schedule
• Must be developed for each type of audit that must be performed including GMP / facility inspections, process audits and GFSI system audits
• Effective audit plans manage the time and resources required to meet audit requirement needs without becoming overly burdensome for the operation
• Must be documented and scheduled to assure audits are completed as required
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Developing An Internal Audit Checklist
• All audits should be conducted against a defined standard
• Audits should not be performed by simply walking around with general visual observations with a list of deficiencies noted
• Auditors need a checklist to know what to look for and demonstrate to a Third Party Auditor what was assessed during the internal audit process
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Audit Checklist ComponentsGMP | Facility | Process
• Microbiological Interventions
• Antimicrobial interventions should be audited to assess their efficacy and proper use- Examples could be or antimicrobial sprays or
interventions in a slaughter or raw operation
• Critical operating parameters need to be audited and assessed to assure for:- temperature - time - pressure - pH - other types of controls required
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Conducting the Audit
Opening Meeting
Objective Evidence
Audit Tools
Dealing with a non-conformity
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Collecting Objective Evidence
Is information based on facts that can be proved?
How? • Observing processes• Interviewing personnel• Reviewing documents • Analyzing data
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Objective Evidence
Used to demonstrate when the following have been met:
• Company policy• Company procedure• USDA requirements• GFSI standards• Customer specifications
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Question Types
Open Questions: Used to assess general understanding
Challenging & Probing Questions:Used to evaluate compliance on critical issues
Summarizing & Closed Questions: Used to confirm auditors understanding
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
The Audit Checklist
To be used as a working document and as a record
Tool to audit company, not standard
Should follow the natural processof the organization
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
The Purpose of the Checklist
To guide the auditor
To ensure all elements are completed
To reinforce the audit objectivesand scope
To act as a record
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Managing the Audit Checklist
Assumes that the auditor has an
understanding of the requirements
General checklist:
Identifies areas to be audited
Detailed checklist:
Typically yes or no questions
Audit checklist can be either detailed or general
depending on the experience of the auditor
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Risks of the Checklist
• Too focused on a single area
• Insufficient information included to evaluate conformance in interviews
• Not customized to reflect company specific practices
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Preparing the Checklist
• The food safety policy• Objectives associated with the area to be audited
• Interactions between the processes
• Activities under way• Relevant procedures
• Other documents being used• Records being maintained• Staff competence requirements
• Procedure or standard requirements
• Process‐based auditing techniques
Must consider:
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Conducting Inspections
• Carry a flashlight and open mind• Look everywhere
- Open drawers- Under storage racks- Behind vending machines- Overheads- Idle equipment
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Conducting Inspections
• Outside grounds• All production and storage areas• Support areas
- Restrooms- Locker rooms- Cafeteria- Laundry rooms- Boiler rooms- Water treatment areas
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Dealing with a non‐conformity
5. Where critical non conformity is found stop the process and
inform the auditee and Supervisor/Manager
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Closing and Reporting the Audit
Reporting the AuditReporting the Audit
1. Prepare for
closing meeting
1. Prepare for
closing meeting
2. Audit report
2. Audit report
3. Closing meeting
3. Closing meeting
4. Closing out
non-conformities
4. Closing out
non-conformities
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Conducting the Closing Meeting
• Confirm area covered by the audit
• Provide overview of positive points raised during the audit
• Read out non‐conformities (where appropriate)
• Agree on corrective action(s)
• Agree on timescales
• Thank everybody for their time and cooperation
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Audit Follow Up
• There are three types of audit follow up:
Re audit
Auditee to provide documentary evidence
Cover at the next audit
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Corrective Actions and Learnings
27
Internal Audit
Conduct an Internal Audit
Identify Non-Conformances
Implement Corrective
Actions
Repeat and Verify by
Process / Dept
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Effectiveness of corrective action
Possible methods of verifying corrective actions:• Interview personnel on corrective and preventive action carried out• Review any amended documents e.g. policies, procedures etc.• Check training records where training has been given• Review process records• Observe process activities
28
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Proper Corrective Action Documentation
• Corrective actions must be documented for all non‐conformances identified - Document the correction,
corrective action and verification of the effectiveness of the corrective actions
- Target dates and completed dates should be documented for each non‐conformance identified
• Before and after pictures are a good best practice
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Corrective Action Verification
• Corrective actions must be verified to assure they have been effectively developed, implemented and sustained
• Complete with follow up inspections prior to or during the next audit cycle
• Corrective action verification must be documented to show that it has been performed
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Corrective Action Follow Up
• There must be a process to follow up on prior audit reports
• The audit team should review the list of open and closed corrective actions at each monthly audit team meeting
• Non‐conformances that have assigned work orders to must be double checked to their completion
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Best Practices To Eliminate Top Audit Non‐Conformances
Procedure Audits
Area Best Practices To Eliminate Gaps
Food Safety Plan Verify Flow Charts; Identify Correct Hazards; Validate Critical Limits; Perform Monitoring and Verification
Records Eliminate Write overs; Assure Legibility; Assure All Information Is Complete, Accurate and Timely
Internal Audits Implement Corrective Actions For Deficiencies Identified; Complete As Scheduled
Allergen Management Assure Proper Storage; Complete Allergen Validation; Assure Effective Sanitation and Changeovers
Business Continuity Planning Assure Proper Threats Are identified; Complete Effective Tests; Keep CMT Contact List Current
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Best Practices To Eliminate Top Audit Non‐Conformances
Facility Audits
Area Best Practices To Eliminate Gaps
Equipment, Utensils and Protective Clothing Maintain Conveyor Belts; Eliminate Frayed Plastic On Utensils; Prevent Overhead Contamination Risk
Walls, Partitions, Doors and Ceilings Prevent and Repair Damage; Establish Effective Facility PM Inspection; Prevent Roof Leaks
Floors, Drains, and Waste Traps Prevent Puddling Water; Seal Cracks In Floors; Maintain Sanitary Drains
Dust, Fly, and Vermin Proofing Prevent Pest Activity; Assure Proper Seals Under and Around Doors and Windows
Control of Foreign Matter Contamination Use Effective Foreign Material Control Methods; Monitor Devices As Scheduled; Manage Findings
Animal Welfare Audit daily to verify compliance; Use video surveillance for 24/7 continuous monitoring; Train all employees on importance and liabilities of non-compliance
Antimicrobial Interventions Audit daily to assure effectiveness; Assure critical operational parameters are continuously met
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Improving Internal Audit Processes• Challenge
- develop a robust integrated internal audit process for GFSI systems, facility/GMP and process audits
• Train- Internal auditors must know what to look for, document results
properly, and assure corrective actions are properly implemented
• Conduct- effective internal audits for improvements, not compliance
• Report- report results to management for awareness and follow up
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Connecting the Dots to Make It All Work
• Integrate- review all types of audit results to view the whole picture
• System- implement an electronic food safety and quality
management system to manage results on the dashboard
• Continuously Improve- update audit checklists and management review processes
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Conclusion
• Internal Audits are a critical part of the food safety and quality management system
• Internal Audits must be completed routinely to verify program sustainment, identify failures and implement corrective actions as needed
• Internal Audits can be used to identify continuous improvement opportunities for many programs.
F O U N D AT I O N F O R
R E S E A R C H E D U C A T I O NM E AT P O U LT R Y
Jeff [email protected]
Schedule a free 30‐minute consultation:706.483.4400 | www.alchemysystems.com