HOW TO CREATE AN AUDIT READY
PHILOSOPHY AND CULTURE
21 June 2011
By: Jake Walton
Regulatory Auditor, Nelson Laboratories, Inc.
What is Audit Readiness?
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Being audit ready means that your systems
are ALWAYS ready to be audited, regardless
of who is looking
What kinds of audits are happening at your company?
• Internal customers
• External customers
• Certification bodies
• Regulatory bodies
• Etc.
Assess Your Foundation
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Let’s breathe
Are there cracks?
What needs to be repaired?
Are past repairs holding?
Fix The Cracks
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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)***
Getting To Your Goal
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“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***
Communicate the Objective
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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***
Change the Culture
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Teach Rather Than Police
• Teach (explain the “whys”)
• Share understanding (two-way street)
• Respect processes/ideas
Involve
• Audits
• Investigations
Help People Achieve
• Don’t drop items on others (the spouse list)
• Assist in making goals a reality
• Suggest vs. demand
Change the Culture
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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***
Tools For Success
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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)
Tools For Success
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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***
Tools For Success
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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
Inspect What You Expect
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Pre-Audit Inspections (When Possible)
• Walk-through of critical areas
• Warn staff likely to be involved
***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
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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:
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Training
Labeling
Validations
Calibrations
ISO17025 Reference Sheet
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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.
Inspect What You Expect
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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?
***Teach best practices and reward good behavior***
Be Proactive
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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.
Be Proactive
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Create Programs that TEACH!
• Quality 360
Be Proactive
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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.
Be Proactive
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Follow-Through
• Ensure actions were taken
• Ensure actions were effective
• Look at other areas to implement actions
***Repeat observations will take you down. Formulate a
system to ensure that all audit observations are taken care
of***
Be Proactive
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Risk Based Justification
• If several auditors have raised the same question, and
you have keep defending that process, have a riskbased written justification ready.
***Well written justifications can save an audit***
Measure the Results
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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)
Measure the Results
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Keep Metrics
• Looking at cumulative data tells you where your
weaknesses and strengths are
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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
***Keep your metrics current and audit ready***
Measure the Results
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Compare Data to Find Holes
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External
Internal
Complaints
CAPA
Etc
Final Thoughts
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People can’t change what they don’t know
If you are willing to teach, you will succeed
Explain, explain, explain
Be the change that you want to see (Gandhi)
Changing habits/minds/processes takes time
Questions/Comments
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Email:
Jake Walton
jwalton@nelsonlabs.com