tracegains - expediting the audit process webinar

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:

6

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:

13

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:

14

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

cpetrlik@ticgums.com

Texture + Stability Solutions

Thank you

19

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GFSI

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Q&A

Gary Nowacki

gary.nowacki@tracegains.com

Chris Petrlik-Siegel

cpetrlik@ticgums.com