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ISO/IEC 17025 Road to Accreditation:The Journey Continues
A collaborative effort of:
Association of Public Health Laboratories,
Food and Drug Administration,
Association of Food and Drug Officials, and
Association of American Feed Control Officials
Brenda Jackson, MS, Quality Systems Manager, Food & Drug ProtectionDivision, North Carolina Department of Agriculture
Louise Ogden, BS, Quality Assurance Officer, Laboratory Services Division, Minnesota Department of Agriculture
Gail Parker, BS, Quality Manager, Division of Food Safety, Bureau of Chemical Residue Laboratories, Florida Department of Agriculture and Consumer Services
Audrey Pilkington, BS, Assistant Director of Laboratory Services, Food & Drug Protection Division, North Carolina Department of Agriculture
Yvonne Salfinger, MS, APHL Consultant, Denver, CO and Retired Bureau Chief, Division of Food Safety, Bureau of Food Laboratories, Florida Department of Agriculture and Consumer Services
Tracy Stiles, MS, M(ASCP), Director, Microbiology Division, Massachusetts State Laboratory
Sharon Webb, Ph.D., Director of the Quality Program for the University of Kentucky, Division of Regulatory Services
Welcome to the webinar, ISO/IEC 17025 Road to Accreditation: The Journey Continues.
This is the second webinar in a series to assist in the achievement, enhancement, or maintenance of ISO/IEC 17025 accreditation.
Content is based on questions we received in response to the first webinar.
Objectives:• Discuss the value of accreditation• Develop an approach for ensuring top‐level support for achieving
accreditation• List the differences between an internal audit and an external audit • Identify the elements of corrective action and when it is needed
Easier to find records‐ laboratories more systematic in
Knowing what must be recorded, and how
Indexing
Storing
Provide a positive service to regulated entities
Simplify (and de‐stress) responding to legal challenges and records requests
Streamline routine tasks
Encourage data acceptance and improve speed of response actions by partner agencies
Educate administration on value and benefits:
Value of accurate tests to producers – fast, accurate results minimize market impact
Protecting citizens’ lives and health
Aids in legal proceedings – data accurate, traceable, defensible
Solicit help from stakeholders: customers, agency legal staff, state legislators, state Food Associations
Show how your laboratory’s work protects your citizens: better acceptance of results improves emergency response and cross‐agency collaboration
Report: “How does using an accredited laboratory benefit government and regulators?” https://www.ilac.org/prom_brochure.html
Let your stakeholders help you promote accreditation to your managers
Invite to ISO/IEC 17025 training: Top management Budget/finance staff IT staff
Provide regular progress reports, with metrics
ALACC is optional
Confirm your choice of options with your Accreditation Body (AB) before applying for accreditation
Speakers agree – the Analytical Laboratory Accreditation Criteria Committee (ALACC) guidance document is of value to food testing laboratories
Most current U.S. AB’s are able to accredit your laboratory to it
In‐house database – Access (or other) SharePoint or SharePoint‐like “Web catalog” with HTML pages
acting as a Table of Contents with links to documents in network folders Lock PDFs against printing Folder access controls can be used to prevent document changes or
deletions
Homegrown (labor‐intensive) systems often require about 1 FTE to operate/maintain
Consider pooling resources with other laboratories/groups to buy off‐the‐shelf solution
“Cloud” or vendor‐hosted document control software often cheaper, faster, simpler to implement
Considerations: Internet outage = No document access What if company folds? Can documents/records be recovered out of their system? Will secure documents be allowed to be hosted offsite (i.e., Select Agent or other
items)
Training can be tracked on paper forms, and/or Access/Excel database File by date or trainee/date Hard to track when multiple trainings are delivered to multiple staff (i.e., on
document revisions) and all records must be retrieved Need a system to catch when trainings are missed
Document hardcopy tracking Make people responsible for own copies – not for a group’s copies Copies must be retrieved when superseded or retired Issued copies must be tracked; numbering is a good idea “Uncontrolled when printed” or “Uncontrolled after 24 hours” not a good
practice! (Obsolete instructions are required to be removed from point of use).
Going paperless Resistance may occur, but is an ideal solution (if it works for your laboratory) Tablets or laptops with wireless access In‐laboratory PC’s with dishwasher‐safe keyboards and mice, clean shields,
and/or wall/ceiling mounted monitors
Too little detail may lead to ‘procedural drift’ Must suit your staff’s level of experience, and the procedural
requirements High turnover = Highly‐detailed standard operating procedures (SOP) High experience = less detail Method with quality‐critical parameters = high specificity
Don’t be overly precise or prescriptive (unless you have to be) Avoid numbering/lettering procedural steps (use bullets) Use words/phrases like ‘about’, ‘approximately’, ‘or equivalent’, ‘usually’, or
‘normally’, if applicable
Written instructions must be performed as written (if SOP says “5 minutes”, then the requirement is exactly 5 minutes) Is the parameter quality‐critical? Does it need to be recorded?
Deviations from written requirements always require documented preapproval
Be sure instructions are logical and linear, without excessive and potentially confusing jumps back and forth in doc
Everything should be specified before it is needed, especially preparation steps to do ahead
Procedure should be readable by a person working in the laboratory Text too dense or too small? Formatting archaic or unwieldy? Paragraphs too long? Unnecessarily verbose, or too many long words where short ones will do? Page breaks at critical points in the procedure, where analyst has no free hand to
turn the page?
Add visual cues: tables, flowcharts, pictures, etc. Can procedure be done exactly as written? Write what you normally do – don’t include all possible options Be sure it is what the laboratory staff are doing versus what you think
they are...
Immediately! Can help identify gaps and correct them BEFORE your AB arrives Your AB may require you to have completed a full cycle of internal audits before
your initial onsite visit
Observe other accredited laboratories performing audits Many training resources available, including audit checklists Can be very educational When you see a problem in one area, it may be elsewhere Train and authorize your auditors, and maintain their competencies
and other records
Set a reasonable schedule for auditing – you don’t have to require yourselves to audit all methods each year
Have multiple auditors, and ‘switch them up’ Don’t have the same person audit the same method every time Laboratory directors can audit management system sections Check on auditors frequently to make sure they stay on schedule Generate and retain ‘audit evidence’: what did you watch, review,
observe? Always good to issue an audit summary of your findings:
nonconformances as well as suggestions for improvement
All elements of your quality system including ISO/IEC 17025 requirements Accrediting body requirements/policies Your quality manual, procedures, and methods (to be placed) on your scope of
accreditation Customer requirements, such as
Contracts with external agencies, e.g., CDC, FDA, USDA Items that should be specified somehow in your own quality management system
(QMS), such as Waste disposal regulations, other local regulations Your own agency’s rules, state laws Safety and security
Evidence of auditing your own QMS documents/procedures Can print watermarked ‘audit copies’ of controlled documents to write
on during audit Scan and keep as record/evidence Remember to specify that this is acceptable, in your document control procedure
An audit is a sampling exercise, so you don’t have to review everything… but do record details, e.g. Dates of audit open/close, dates various steps of procedures observed (and by
whom), what was observed, who was observed/interviewed, what was asked/answered
Sample numbers, lot numbers on reagents, equipment IDs, reference weights, calibration certificates examined
For nonconformances Scan or photograph laboratory records Add images to a folder, to simplify the follow‐up corrective action investigation
Try using a summary sheet for the audit report What was covered, when, and by whom Brief summary of findings: nonconformances, observations, recommendations
For future reference/retrieval (during external audits, for example), code or number your audit, nonconformance, improvement action, and corrective action investigation reports, and use these IDs within each related item to refer to the others
All staff: Familiarize them with being audited, via internal audits Hold a group meeting to inform staff about what’s happening, and when Train them
Make sure you understand the question Only answer what you’re asked If you don’t know the answer, it is fine to say that you’d check the procedure,
or the quality system document, or ask your supervisor It is okay to say you’ll need time to look up an answer or a record and get it
to them shortly
A nonconformance isn’t the end of the world
Quality Assurance (QA) staff: Ask a laboratory that’s been audited by your AB, to learn what’s expected of you Observe an external audit, if possible Ask your AB:
About the application process, due dates for: application, money, documentation?
How far back will they want to see records (especially if you use offsite storage)?
Arrange to have a QA person accompany the auditor to ‘translate’ the question into the laboratory’s jargon, if needed
Deficiencies you believe to be incorrect can be challenged after auditors have left; this can give you time to gather evidence and saves onsite time during the audit
Invite all staff to the closing meeting, when the auditors deliver their findings Post the final report where all staff can read it
QA staff (cont’d): Confirm that you can retrieve offsite records in a timely way (or ask the AB in
advance: which offsite records would they like to see?) Ensure that you don’t destroy records for a future audit (what is the AB’s
requirement for records retention?) Ask the AB how long you have to respond to the deficiency report Think about how to structure your records storage for easy retrieval during audits Arrange a place for auditors to spread out documents Have supervisors walk through the laboratory routinely, to make sure it is
neat/clean; equipment labeled, items put away, no uncontrolled or obsolete instructions, etc.
If you have an analyst who is nervous in front of a group, try to limit the number of observers
The ‘5 Whys’ can be a good tool for root cause analysis But first… Make sure you know exactly WHAT happened, before you
apply it Consider the scope of the issue, the extent of it, all the
contributing factors, what was going on at the same time, etc. Do not jump in to root cause analysis until you have the ‘Whats’
established ‘5 Whys’ can be good when you are new to root cause analysis, but as
you gain experience, also explore other options Get the relevant staff members involved – don’t do ‘desk
investigations’ by QA members or supervisors
Corrections Always required Immediate actions taken to correct an observed problem, e.g., fixing an incorrect
ID number in a record
Corrective Actions Action taken to reduce the chance the nonconformance will happen again, e.g.,
revising a method SOP
Not all nonconformances call for them
Example: Laboratory refrigerator temperature check not done Investigate cause and extent of problem; if one‐time oversight, check contents
and make a note of it. (Correction) Was this an ongoing issue? Why? What can be done to correct? (Corrective
Action)
First, don’t confuse a Corrective Action Investigation with a Corrective Action When is a Corrective Action Investigation ALWAYS required?
This is a starting point, not an exhaustive list
ISO/IEC 17025 section Trigger
4.9.2 If a nonconformance may recur, or if there’s any doubt you have complied with your policies/procedures
4.11.1 Departure from a written requirement without preapproval
AB Policy; ALACC guidance (5.9.1) Unacceptable Proficiency Test result
4.14.2 Internal audit deficiency
5.9.2 QC data outside of predefined criteria
5.10.1 Data recall
4.8 Legitimate customer complaints
When a thorough root cause investigation has been done Should be very rare Do a cost‐benefit analysis, taking into account the chance of recurrence
and the severity of the impact if it should recur Try group brainstorming first An example from one laboratory has ~6% rate of ‘root cause
undetermined’ Many were random QC failures which passed when rerun May schedule a follow‐up audit to see if it’s recurred
Not a good root cause There is likely to be one or more underlying cause, such as
Lack of time, space, or resources; rushing Analyst distracted or tired Analyst didn’t have a copy of the procedure Inadequate supervision or training Poor logistics, workflow
Try counting, tracking, looking for patterns External auditors may take a closer look if you have a lot of human
error root causes – wouldn’t you rather be the ones to do that?
It may be a luxury rather than a necessity Get help from supervisors – not just the QA staff Think outside the box
Webinars Videos Free/low cost resources Have trainees explain things, as a group exercise (QA as facilitator) Gameshow ProTM software
Not all staff need an equal degree of familiarity with ISO/IEC 17025
On the other hand, it could be very useful Not everyone is a good trainer! Can be hard for staff to train and critically evaluate each other on
technique Using existing staff as trainers reduces their productivity, which can
be significantly negative for the laboratory, especially with senior staff members
May depend on the size of your scope (and turnover/training needs)
Some assessors require it – and you can’t know which assessor you’ll get every time
Can use a binary system: 1/0 for pass/fail Can also be recorded by color‐coding Some laboratories find it useful in spotting trends; others do not It can be valuable as audit evidence that methods are performing
as expected
Accreditation is not a substitute for common sense!
Ultimately, all these puzzle pieces will come together to form your quality system
Send any follow‐up questions to: [email protected]
For more information about ISO/IEC 17025 Accreditation go to:http://www.aphl.org/aphlprograms/food/laboratory‐accrediation/pages/default.aspx
The following laboratories maintain A2LA accreditation to ISO/IEC 17025 for the specific tests listed in A2LA certificates as listed below:
• State of FloridaDepartment of Agriculture and Consumer Services, Bureau of Chemical Residue Laboratories Certificate Number: 2534.03
• State of MinnesotaMinnesota Department of Agriculture, Laboratory Services DivisionCertificate Number: 3171.01 and 3171.02
• State of North CarolinaNorth Carolina Department of Agriculture & Consumer Services Certificate Number: 2967.01 and 2967.02
APHL has collaborated with the Food and Drug Administration, the Association of Food and Drug Officials
and the Association of American Feed Control Officials to bring you this program.
For more information and resources about ISO/IEC 17025 Accreditation go to:
http://www.aphl.org/aphlprograms/food/laboratory-accrediation/pages/default.aspx
We value your input!
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Can’t find the confirmation email? Please contact Josh at [email protected].