North Carolina Department of Agriculture & Consumer Services Food & Drug Protection Division.

One Lab’s Journey to Accreditation

The Long & Winding Road

North Carolina Department of Agriculture & Consumer ServicesFood & Drug Protection Division

NCDA&CS Food & Drug LabWho we are now• ~55 employees in 5 lab sections + QA group• 64 methods accredited in microbiology and chemistry• Pesticide Residue• Food Chemistry• Feed• Fertilizer• Microbiology

• Owners of 950 versions of 300 documents (quality and technical), over 300 logbooks, over 400 worksheets, QMS software, and one big sign.

Prologue: Once Upon a Time…• Lab full of experienced, knowledgeable scientists.• Generated sound data.• Sometimes had controlled documents.

• A customer (MPID) required “equivalency” to USDA accredited lab.• Division Management: equivalent = accredited

• Upper management committed to having an ISO 17025 accredited lab equivalent to our federal partner labs.

Management Commitment•Dedicated QA staff• Positions taken out of lab• Personnel specifically charged with driving accreditation• Conscious decision not to simply layer all accreditation

responsibilities on lab personnel.

•QA group in North Carolina• QA Manager – reports to Assistant Director for Laboratory

Operations• QA Specialist – Chemistry• QA Specialist – Microbiology• QA administrative support

Chapter 1: The Journey Begins• ISO Kick-Off (Jan 24, 2007)• Off-site event for lab staff and management• Invited speakers – “heavy hitters”

• Customers, state & federal• Public Health Officials• Other state & federal representatives from accredited labs

• Explain accreditation • What is it• Benefits• Tie accreditation to agency mission

• The ship has left the dock

Speaker Affiliation

Joe Reardon NCDA&CS Food & Drug Protection Division Director

Steve Troxler

NC Commissioner of Agriculture

Dr. Wells NCDA Meat & Poultry Inspection Division Director

Dr. Jeff Engle

NC Dept. of Health & Human Services, Division of Public Health

Phil Mintz NCSU IES, Manager ISO 9000 Products

Gary Dykstra

FDA SE Region Food & Drug Director

Dr. Marion Aller

Director, Division of Food Safety, Florida Dept. of Agriculture & Consumer Services

Cathy Pentz

Chief – Microbiology QA Branch, USDA/FSIS Laboratory QA Division

So, what do I have to do?(You don’t know what you don’t know)

• 3/2007: Consultant provided lunch & learn on ISO 9001 principles• ISO is not just a “food thing” – it’s been around a long time in many places

• 5/2007: Consultant provided on-site 3-day course in ISO 17025 for supervisors• 5/2007: Consultant provided half day course for everyone• Documentation examples from other labs• 10/2007: QA Staff took 5 day ISO 17025 course• 10/2007: QA Staff took Measurement Uncertainty course• 2/2008: Consultant provided on-site 2 day course in auditing ISO

17025

Digging In• What to accredit?• MPID…Microbiology….Food Testing….Regulatory Testing

• Start with the low hanging fruit• Test Methods

• Team approach to QMS documents• Get the lab involved, have QA do the writing & research

• 2008: Hired QC Specialist with 3rd party audit credentials• Audit

• The gaps and questions raised helped focus efforts.

Challenges & Benefits• How to limit the scope of work

• Ex: check balances daily in certain areas, or all areas?• Ex: controlled worksheets everywhere?• Standardization & consistency benefit staff & management• Implementing requirements improves understanding of ISO

17025

• Living the system as it’s being written• ISO 17025 is comprised of inter-related requirements• Quality systems are born one document at a time• Revisions can be frustrating, but also reflect progress and

improvements

Challenges & Benefits• Review of all lab processes by all levels

• Supervision/management may learn of needs, inefficiencies, opportunities• Commitment to ISO implementation may equal commitment for

improvement

• Examples:• New block digesters in fertilizer, 4x as many samples/day• Progress impressed customer, who shared funding to help us obtain

equipment to improve splitting/grinding operation• Progress impressed customer, who shared funding to help purchase

analytical equipment• Documented, approved procedures for determining when to re-run

samples (especially feeds & fertilizers)

Challenges & Benefits• Resistance• It’s different.• It’s more work.• Are you telling me my data isn’t accurate?• I just don’t like it.

• Some people need time to adapt, some never do.• Attrition may be a part of the change process.

• HR needs to be involved & understand the changes occurring• Expectations change• Grievances may increase

Chapter 2: Halfway There

• Off-site celebration for staff & guests• Upper management• Public Health Officials• Department Counsel• FDA Quality Manager

• Reminder of motivations & benefits• Experience at FDA labs• Encouragement• Lots of Q&A time with experienced FDA QA Manager

Time to make a schedule• Assessment occurs ~60 days after application• Renewal assessment ~24 month intervals after initial

assessment• Determined best time for assessments and worked

backwards to create a timeline• Assessment – 2 months, application• Assessment – 6 months, full internal audit• Assessment – 9 months, document reviews & training record

reviews• Assessment – 12 months, begin Management Review cycle• Assessment – 12 months, ensure calibration records (i.e.

balance, etc)• Etc…..

Take Advantage of Opportunities• Building maintenance project required shutdown – training

opportunity• 2009 budget restrictions

• Cut out inspector travel, therefore limited samples• Opportunity to ensure implementation of QMS in lab by lab staff

• Recognition opportunities• Departmental programs (Employee of the Month, State of Dept

address)• URoC Awards

• Update the lab• Newsletter – and have some fun with it

Chapter 3: Application• Really, we’re ready? But we’ve only• Audited every clause for every method in every lab• Created 7 databases to track records• Found and corrected over 100 nonconformities• Completed the 80 page ISO 17025 checklist from AB (103

pages when completed) and found no gaps

• September 2, 2009 submitted application (2 ½ years from Kickoff)

• OMG! What have we done? (Sept –Dec 2009)

Chapter 4: Assessment• 3 days• Over-prepared• Unexpected pleasant surprises• Full, eager participation in labs• Friendly competition

• Final report included deficiencies – we fixed them• Conclusion – that wasn’t so bad!

Chapter 5: Praise & Party• March 30, 2010 Accreditation received (38 mo after

Kickoff)• April 19, 2010 Commissioner’s press release• July 29, 2010 Accreditation Recognition Celebration• All Department management• Presentation of Accreditation certificates• Presentation of FDA Recognition of Excellence by Carl

Sciacchatano• Presentation of recognition certificates to all staff• Door prizes

• 2011 NC Governor’s Award for Excellence

Epilogue: Reflections

What we did well• Planning

• Generally well planned implementation

• Good strategy for timing of recurring assessment

• Accreditation progression• Understand how your

accreditation can grow/change

• Took advantage of opportunities for training• Celebrations!

What could have been improved

• Planning• Involve HR earlier • More change management

training for lab

• Accreditation progression• Tried for too much initially

• Anticipate resistance, amount of change

The Journey Continues…..• Accreditation is the beginning, not the end of the

journey.• (the assessors come back!)

• Continuous improvement, education, revisions are ongoing.• ISO 17025 becomes a part of life.

Thank you

• Brenda Jackson

Quality Systems [email protected]