Q&A
Today’s Presenters
Christina Petrlik-SiegelSupplier Quality ManagerTIC Gums
Gary NowackiCEOTraceGains
Texture + Stability Solutions
Expediting the Audit
Process
September 25, 2014
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.
5
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”
7
Texture + Stability Solutions
Create and engage an audit team of
subject matter experts (continued)
8
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.
Texture + Stability Solutions
Create and engage an audit team of
subject matter experts (continued)
9
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
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
10
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
11
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
12
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
15
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
16
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.
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)
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”
18
Christina K. Petrlik-Siegel
Supplier Quality Manager
Texture + Stability Solutions
Thank you
19
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GFSI
Labeling
FSMA
Audits
TraceGains Automation Solves Many Problems
GFSI
Labeling
FSMA
Audits
