HOW TO CREATE AN AUDIT READY PHILOSOPHY AND CULTURE By: Jake Walton Regulatory Auditor, Nelson Laboratories, Inc. 21 June 2011.

HOW TO CREATE AN AUDIT READY PHILOSOPHY AND

CULTURE

By: Jake WaltonRegulatory Auditor, Nelson Laboratories, Inc.21 June 2011

What is Audit Readiness?

Being audit ready means that your systems are ALWAYS ready to be audited, regardless of who is looking

• Internal customers• External customers• Certification bodies• Regulatory bodies• Etc.

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What kinds of audits are happening at your company?

Assess Your Foundation3

Are there cracks?

Are past repairs holding?

What needs to be repaired?

Let’s breathe

Fix The Cracks

What is Your Objective?

Set a SMART Goal• Specific• Measurable• Attainable• Realistic• Timely

***Start small, prove the concept, and apply it again in a bigger format (creating a snowball effect)***

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Getting To Your Goal

“A goal without a plan, is just a wish” – Larry Elder

Formulate a Plan of Attack• When/where are you going to start?• Who will be involved?• What resources do you need?• What are my biggest obstacles? • Etc.

***Process map it out***

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Communicate the Objective

Inform• Department• Top Management• Company

Sell Your Objective• Money (waste, cost of quality, grow business, etc.)• Productivity• Process improvements (future ease)

***Sell To Your Audience***

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Change the Culture

Teach Rather Than Police• Teach (explain the “whys”) • Share understanding (two-way street)• Respect processes/ideas

Involve• Audits• Investigations

Help People Achieve

• Assist in making goals a reality • Don’t drop items on others (the spouse list)

• Suggest vs. demand

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Change the Culture

Celebrate• Achievements/Improvements• Good times (no findings)

Embrace Audits• How can you make yourself better?• Free consulting (external audits)• Who is the REAL enemy?

***Quality cannot be achieved with a closed mind***

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Tools For Success

Risk, Risk, Risk• Perfect quality vs. acceptable practice • Pick your battles• Make risk based decisions

Walk The Walk• Improve yourself or your department• Allow change in your process• Be approachable

Know Your Audience• When completing/creating documentation• Write, re-write, re-write (avoid red flags)

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Tools For Success

Pre-Audit Tools (For External Audits)• What is going to be audited?• Review past audits

• Is everything fixed from the last audit?• Schedule subject matter experts (SME) and audit team• Pull documents ahead of time• Map out (flow chart) difficult processes

***Run a first class audit***

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Tools For Success

Other Critical Items• Good internal audit program (EA and IA – go together)• Strong CAPA and Complaint programs

• Top 5 483 items pertain to these systems• Effective, efficient, and well written SOP’s• Policies and procedures to control forms • Create unbroken audit trails

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Inspect What You Expect

Pre-Audit Inspections (When Possible) • Walk-through of critical areas• Warn staff likely to be involved

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***Perform walkthroughs with area managers, teaching as you go. Overtime, they will be able to perform the walkthroughs on their own***

Inspect What You Expect

Internal Audits• First and best line of defense • Create a program that audits against standards

(GMP/ISO/ASTM/AAMI/ETC)• Create a standard vs procedure reference (next slide)

• Audit full processes (not just segments)• Pay special attention to areas that auditors audit:

• Training• Labeling• Validations• Calibrations

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ISO17025 Reference Sheet

4.8 Complaints The laboratory shall have a policy and procedure for the resolution of complaints received from customers or other parties. Records shall be maintained of all complaints and of the investigations and corrective actions taken by the laboratory .

SOPXXXX establishes our policy on how we handle and resolve customer complaints. Records are maintained in Regulatory Affairs, and include the following: complaint initiation, complaint coordinator assignment, investigation, correction, and preventive action (if needed), and complaint closure evidence.  

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Inspect What You Expect

Daily Duties• Train your entire staff to ask themselves,

“what would a customer or auditor think about this?”

• Can it stand alone?• Who is our audience?

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***Teach best practices and reward good behavior***

Be Proactive

Trend All Audit Findings (See Further Slides)• Non-Conformities• Observations• Recommendations

Take Corrective and Preventative Actions• Consider recommendations to be free consulting

and take action where you see patterns or benefit.

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Be Proactive

Create Programs that TEACH!

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• Quality 360

Be Proactive

Collaborate• Hold meetings with areas of higher

criticality, or repeat findings, and collaboratively work with personnel to find optimal solutions.

• Simply making decisions and pushing agendas on outside areas WILL NOT WORK.

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Be Proactive

Follow-Through • Ensure actions were taken• Ensure actions were effective• Look at other areas to implement actions

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***Repeat observations will take you down. Formulate a system to ensure that all audit observations are taken care of***

Be Proactive

Risk Based Justification• If several auditors have raised the same

question, and you have keep defending that process, have a risk-based written justification ready.

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***Well written justifications can save an audit***

Measure the Results

SMART Goals = Meaningful/Measurable Results

• >95% On-time audit responses (External)• >10% Decrease in Non-Conformities year to year

(External and Internal)• >50% Audits requiring no formal response

(External)

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Measure the Results

Keep Metrics• Looking at cumulative data tells you

where your weaknesses and strengths are• Number of audits and whether 1st time or

repeat• Turn-around time of response• Number and criticality of findings• Responsible area of finding• Procedure finding is governed by

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***Keep your metrics current and audit ready***

Measure the Results

Compare Data to Find Holes• External• Internal• Complaints• CAPA• Etc

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Final Thoughts

People can’t change what they don’t knowIf you are willing to teach, you will succeedExplain, explain, explainBe the change that you want to see

(Gandhi)Changing habits/minds/processes takes

time

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Questions/Comments

Email:

Jake Walton [email protected]

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