tracegains - expediting the audit process webinar
DESCRIPTION
If you have any questions or comments, please send them to [email protected]. We look forward to hearing from you. Successful audit execution is paramount for both the auditor and the entities being audited. It does not happen by chance. While many times the supplier has to deal with an unknown in the auditor, the audit requirements, and how your Food Safety and Quality Management Systems align to meet the audit requirements should be seamless as you present them to the auditor. Christina Petrlik-Siegel, Supplier Quality Manager at TIC Gums, will present some audit strategies to help bolster your audit team to efficiently navigate through and expedite the audit process. -Create and engage an audit team of subject matter experts -Know the audit requirements -Do your homework Design a proactive Internal Audit Process -Is what you are doing working? -Know this before an auditor discovers it -Anticipate critical document and records -Embrace the experience in the spirit of continuous improvementTRANSCRIPT
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Q&A
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Today’s Presenters
Christina Petrlik-SiegelSupplier Quality ManagerTIC Gums
Gary NowackiCEOTraceGains
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Texture + Stability Solutions
Expediting the Audit
Process
September 25, 2014
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Successful audit
execution is paramount
for both the auditor and
the entities being
audited. It does not
happen by chance.
Unknown: Auditor
Known: Audit Criteria
Texture + Stability Solutions
Tip the scales in your favor
by being prepared with an
audit strategy.
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Texture + Stability Solutions
• Create and engage an audit team
of subject matter experts
• Know the audit requirements
• Do your homework
• Anticipate critical documents and
records
• Embrace the experience in the
spirit of continuous improvement
Audit Strategy:
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Texture + Stability Solutions
Create and engage an audit team of
subject matter experts
Not just the QA Manager
• Management Commitment of Resources
• Education & Training of the Workforce
Empower your HACCP/Food Safety &
Food Quality Teams
• They are SME (Subject Matter Experts)
• They have ownership too
• They need to know what you know – “no man is an island”
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Texture + Stability Solutions
Create and engage an audit team of
subject matter experts (continued)
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Book times to provide formal audit training to the audit
standards.
• Shadowing is sometimes helpful to recruit team members
• Formal GFSI Audit Training
• Formal Internal Auditor Training
Book the audit times on the team members’
calendars.
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Texture + Stability Solutions
Create and engage an audit team of
subject matter experts (continued)
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For Customer Audits, share any customer
specific checklists.
Know your Company’s Salesperson and Customer Service
Representative names and email contacts
Know what products you sell to the customer
• Have those finished goods specifications readily available
• May lead to raw material & packaging
information search (COAs, LOG, CCG etc.)
Know how to get the testing data/records
quickly
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Texture + Stability Solutions
Know the audit requirements
21 CFR Section 110
FSMA (Food Safety Modernization Act)
GFSI Standards
• 10 Benchmarked Standards
http://www.mygfsi.com/about-gfsi/gfsi-recognised-schemes.html
Customer Audits
• Ask for audit requirements
• Checklists
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Texture + Stability Solutions
Know the audit requirements
(continued)
Map your documents to the schemes
• Mapping Checklists
• Hyperlinks
• Search Functions
Location is everything – know how to find the
requested information quickly
• Rehearse with the Audit Team
• Waiting is painful for all involved
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Texture + Stability Solutions
Do your homework
• Confirm the audit dates with the auditor
• Reserve a conference room for the duration
of the audit
• Check the IT systems
• Arrange to have lunch brought in (ask the
auditor if there are any special dietary
requirements such as gluten free,
kosher, etc.)
The Easy Things
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Texture + Stability Solutions
Do your homework
Internal Audit Design
• Internal Audit Team Trained in Internal Audits
• Not only GMP Audits but System Audits
• Assesses the entire audit scheme
• Monitoring - Verification - Validation
• DWYSYWD
• Is what you are doing working
The Harder Things:
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Texture + Stability Solutions
Do your homework
Internal Audit Execution
• Monthly Exercises
• Teams of 2 with a trainee
• Findings – Good & Bad
• Report to Management Team
• Findings tracked to completion
• Review data for trends
More Harder Things:
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Texture + Stability Solutions
Anticipate critical documents & records
Policies and procedures required by the audit
• Electronic files
• View via projection or “big screen” monitors
• If binders, know how to locate information quickly
HACCP Records
• CCP Records
• Training records for those monitoring a CCP
• Calibration Records
Last Audit Report findings & Corrective Action Responses
• Regulatory Audits
• GFSI Audits
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Texture + Stability Solutions
Anticipate critical documents & records
(continued)
Pest Control Records
Complaints
Traceability
• Past year’s information
• Live exercise – have a trained team member on
stand-by
………………And anything else covered by the audit scheme
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Hint
Delegate a “runner” from your audit team to
retrieve anything you did not anticipate, and
move on to another topic to keep the process
flowing.
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Texture + Stability Solutions17
If the Internal Audit
Process is working, it is
your best buffer for the
information storm that is
about to occur.
Anticipate critical documents & records
(continued)
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Texture + Stability Solutions
Embrace the experience in the spirit
of continuous improvement
Audits are snapshots
Many eyes see different things
Act professional – do not take it personal
Beware of “low hanging fruit”
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Christina K. Petrlik-Siegel
Supplier Quality Manager
Texture + Stability Solutions
Thank you
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Documentation — Turning Static Data Into Information
Typical
24/7 Detection& Compliance
Automation
TraceGainsDynamic
Information
AutomaticScorecarding
Difficult to search, analyze, andtake action
Instant eNotificationAlerts
No More Spreadsheets: Documents to Data
Static Data
COAsSupplier Documents
Finished Goods Quality
Machine Maint.
Receiving
Receiving Inspections Lab Results
Auto. P.O.Acknowl.
Plant Floor Feedback
Finished Goods QA
COA
ActionForm™
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TraceGains Automation Solves Many Problems
GFSI
Labeling
FSMA
Audits
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TraceGains Automation Solves Many Problems
GFSI
Labeling
FSMA
Audits