February 3 2016 Government Food and Feed Accreditation meeting Ensuring a Smooth ISOIEC 17025 Accreditation Assessment Tips on Reducing the Uncertainty and Anxiety of an Upcoming Auditor Visit ID: 705140
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Slide1
Roger Brauninger American Association for Laboratory Accreditation Frederick, Maryland
February 3, 2016 Government Food and Feed Accreditation meeting
Ensuring a Smooth ISO/IEC 17025 Accreditation Assessment
Tips on Reducing the Uncertainty and Anxiety
of an Upcoming Auditor Visit
.Slide2
TopicsPretest Exercise
What is Accreditation?Preparing for assessmentRequirements, records & documentationGap &
Preassessment auditsOn-site assessment actions
Potential
“Rabbit
HolesSlide3
Pretest ExerciseSlide4
QuizzAll of the questions in this quiz relate to requirements of the current edition of ISO/IEC 17025.
Each question offers you four multiple-choice answers (a, b, c
, or d). When ready hold up the colored card(s) which correspond to the
correct answer(s
).Slide5
In what year was the current edition
of ISO/IEC 17025 published?a. 1982
b. 1999c. 2005
d.
1990Slide6
In what year was the current edition of
ISO/IEC 17025 published?a. 1982 b.
1999c. 2005
d.
1990Slide7
ISO/IEC 17025 requires the laboratory to conduct audits of its activities______:a.
Every 6 monthsb. At least once/yearc. At predetermined intervals decided
by the laboratory d.
Whenever testing problems are
foundSlide8
ISO/IEC 17025 requires the laboratory to conduct audits of its activities______:a.
Every 6 monthsb. At least once/yearc. At predetermined intervals decided by
the laboratory d.
Whenever testing problems are
foundSlide9
ISO/IEC 17025 requires that management reviews are conducted_______:a.
Every 6 monthsb. At least once/yearc. At predetermined intervals decided by
the laboratory d.
Whenever testing problems
are foundSlide10
ISO/IEC 17025 requires that management reviews are conducted_______:a. Every 6 months
b. At least once/yearc. At predetermined intervals decided by the
laboratory d. Whenever testing problems are
foundSlide11
ISO/IEC 17025 requires the laboratory to notify the client in writing if_______:a. Any of the tests are to
be subcontractedb. The test item is unsuitable for testingc. Audits reveal doubts about the test
resultsd. A non-standard test method is to
be used Slide12
ISO/IEC 17025 requires the laboratory to notify the client in writing if_______:a. Any of the tests are to be
subcontractedb. The test item is unsuitable for testingc. Audits reveal doubts about the test
resultsd. A non-standard test method is to be
used Slide13
5. ISO/IEC 17025 does not require a laboratory to document________:
a. Instructions for the operation of testing and measuring equipment
b. Its procedures for purchasing and storing laboratory consumables
c.
Its procedures for
subcontracting testing
work
d.
Its procedures for document controlSlide14
5. ISO/IEC 17025 does not require a laboratory to document________:a.
Instructions for the operation of testing and measuring equipmentb. Its procedures for purchasing and
storing laboratory consumablesc. Its procedures for subcontracting
testing
work
d. Its procedures for document controlSlide15
ISO/IEC 17025 requires a laboratory to keep records of_______:a. Customer complaints
b. Staff trainingc. Results of auditsd.
Management reviewsSlide16
ISO/IEC 17025 requires a laboratory to keep records of_______:a. Customer complaints
b. Staff trainingc. Results of auditsd.
Management reviewsSlide17
ISO/IEC 17025 requires the laboratory to ________:a. Control access to testing and
measurement areasb. Protect confidentiality of its test results
c. Comply with laws relating to laboratory safety
d.
Have air conditioning which controls temperature
and
humiditySlide18
ISO/IEC 17025 requires the laboratory to ________:a. Control access to testing and
measurement areasb. Protect confidentiality of its test results
c. Comply with laws relating to laboratory safety
d.
Have air conditioning which controls
temperature
and humiditySlide19
With respect to test equipment, a lab that complies with ISO/IEC 17025 must________:a.
Ensure that all such equipment which affects accuracy must be calibratedb. Own and control all of the equipment
that it usesc. Attach a label to the equipment showing
its
calibration
status
d.
Stop using the equipment if it is not
operating correctlySlide20
With respect to test equipment, a lab that complies with ISO/IEC 17025 must________:a.
Ensure that all such equipment which affects accuracy must be calibratedb. Own and control all of the equipment
that it usesc.
Attach a label to the equipment
showing
its
calibration
status
d.
Stop using the equipment if it is not
operating correctlySlide21
Before subcontracting any testing work to another laboratory, a lab which complies with ISO/IEC 17025 must first _______:
a. Obtain a copy of the other laboratory’s quality manualb.
Ensure that the other laboratory is accredited to ISO/IEC 17025
c.
Ensure that the other laboratory
is competent
d.
Obtain a copy of the other laboratory’s
price
listSlide22
Before subcontracting any testing work to another laboratory, a lab which complies with ISO/IEC 17025 must first _______:
a. Obtain a copy of the other laboratory’s quality manualb.
Ensure that the other laboratory is accredited to ISO/IEC 17025 c.
Ensure that the other laboratory is
competent
d.
Obtain a copy of the other laboratory’s
price listSlide23
A laboratory that complies with ISO/IEC 17025 would also meet the principles of______?a.
ISO 9001-2000 Quality Management Systems b. EN45001-1989 General criteria for the operation
of testing laboratoriesc.
ANSI/ASQC Q.2-1991 Guidelines for
Quality Management
and Systems
d.
ISO/IEC 17011 General Requirements
for Laboratory
AccreditationSlide24
A laboratory that complies with ISO/IEC 17025 would also meet the principles of______?a.
ISO 9001-2000 Quality Management Systems b. EN45001-1989 General criteria for the operation
of testing laboratoriesc. ANSI/ASQC Q.2-1991 Guidelines for Quality Management
and Systems
d.
ISO/IEC 17011 General Requirements
for Laboratory
AccreditationSlide25
What is Accreditation?Slide26
What is Accreditation?Process, to determine an organization’s
competence to carry out specific tasks:
By independent 3rd party accreditation bodyRecognizes via a certificate and scope
Requires periodic monitoring of performance and regular reassessment
Prerequisites
: compliance with ISO/IEC 17025.Slide27
Accreditation Ten Second Tutorial
Doing what you say
you are doingAnd being able to
prove
it!Slide28
Three Critical Thoughts
Does the laboratory “say” what they do?
Is there written documents (policies, procedures, arrangements) that meet the requirements of ISO 17025?
Does the laboratory
“
do
”
what they say?
Are they in
compliance
with their own quality system, test methods and ISO 17025?
And can they
“
prove
”
it with their records?
Ranging from having training
records
to standards preparation to work books to client reports to audit reports and everything in between?Slide29
Scope of Accreditation
Although ISO 17025 is written as though all the methods used by a laboratory are covered by the standard, this is rarely the case.
Methods which are performed infrequently
are difficult to accredit
Hard to demonstrate a track record of performance.
In such cases a large level of quality control will be required by the assessors.
Methods with
little objective content
are difficult to be able to get accredited
Consistency in application cannot be guaranteedSlide30
Quality ManualLays out Quality System roadmapNo set format required
Level of detail based on structure/ function of the laboratory and its’ needsLaboratory’s policies must be included or referenced
Often follows 17025 sequenceSlide31
AOAC Guidelines
Started in 1998 with
FLAWG
precursor.
Additional criteria for:
Personnel
Equipment
cal
and verification
Reagents
Proficiency testing
Internal QC frequencySlide32
Areas Needing Early Start...Proficiency Testing data needed for:
Each major matrix of concernFor as many analytes/methods as possible
Estimates of Measurement Uncertainty Develop Procedures, ID contributing factors
Training on
calculation
(e.g. LCS data)
Traceability of
Calibrations
,
if in-house…
Through an unbroken chain of comparisons, with each step having stated uncertainties
Demonstrable competence performing calibrationSlide33
Preparing…Study to understand requirements
Review/ update all technical and quality procedures, QM policies with technical staffGet involvement from the technical staff in ensuring the lab’s compliance to its QMS
Evaluate readiness with internal audits/ management review or external helpSlide34
Internal audits vs. management reviews
These are two distinct activities:
Internal audits verify conformance
to the documented system and
confirms
the management system is in
compliance
with the standard
Management reviews
determine if the management system policies and procedures
are suitable and effective
in generating quality data, meet the objectives of the laboratory and if
improvements
to meet changing needs are requiredSlide35
Gap Assessment (1st or 3rd party)Prospective focus sets direction and planning.
Looks at A-Z / notes the degree of compliance and Identifies corresponding actions to be taken. Internal audit (1st
or 3rd party)
Retrospective focus on compliance/gathering evidence.
Includes QMS, technical competence and AB’s policies.
Multidimensional, looking at implementation
.
Accreditation body Pre-assessment (3
rd
party)
Mix of both: prospective focus and on compliance.
Primary focus is not on technical.
Types of Preparation AuditsSlide36
During the assessment the assessor determines that there are major non-compliances with the criteria that would lead to a large number of significant deficiencies. In this case, the assessor identifies the potential deficiencies and suggests
to the laboratory that the full formal assessment should wait until the problems have been addressed. This first identification of the problems would be considered a pre-assessment and is optional (i.e., lab could decide to go ahead anyway).
Pre-assessment:
Unplanned for scenario Slide37
During prior document review the assessor identifies major gaps in QM/ lab documentation. The applicant is given time to correct and full assessment follows later. In this case, the assessor identifies the potential deficiencies and
suggests to the laboratory that the full formal assessment should wait until the problems have been addressed. Pre-assessment:
Planned Triggering scenarioSlide38
At time of application lab requests a pre-assessment because it is unsure of its documentation or system. In this case, the assessor identifies the potential deficiencies and full formal assessment takes place after the problems have been addressed.
Ideal time is after both a gap assessment and Internal audit.
Pre-assessment:
Planned Triggering scenarioSlide39
Management SystemISO 17025 requirements explained, Reviews the status of the labs’ preparations,
Responds to suggestions on bringing deficiencies into compliance. TechnicalGeneral technical capability evaluated,
Accommodations, Environment,
Log books
Pre-assessment: Report Slide40
INTERPRETING SOME “ISO” TERMSSlide41
DefinitionsShall = imperative
Should = strong recommendationPolicy = rules – the “what”
Procedure = step-by-step – the “how”Quality System = written policies, procedures, arrangements, etc. (all of the documents)Slide42
“Records”Record
List RegisterFormulateValidate
Evaluate
In Writing
Monitor
Feedback
ISO 17025 defines these words as “records” and
specifies needed evidence of
how actions were done
e.g. (
the “proof”):Slide43
“Documents”DocumentPolicy
Procedure Instruction System Plan
Define
Specify
Pre-defined
Pre-determined
Arrangement
ISO 17025 considers these words as those that describe how activities
are
to be done
(
the “what” and “how”):Slide44
“Weasel Words”“Where practicable”“Where necessary”
“Including but not limited to”“Where appropriate”“Where possible”
“Whenever reasonable”“If relevant” “Where relevant”Slide45
Shall “plus”Shall + “include” –whatever is listed after must be in the procedure or record.
(unless it is accompanied by a weasel)Shall + “ensure”
- The objective evidence (outcome) must show that the stated goal listed in the standard has been met.Slide46
ISO/IEC 17025
ImplementationsRecords
DocumentationSlide47
4.1 - Organization
Green - 17025
Dk. Blue - 17025/Policies & Procedures
Lt. Blue - AOAC Slide48
4.2 - Quality System
Green - 17025
Dk. Blue - 17025/Policies & Procedures
Lt. Blue - AOAC Slide49
4.3 - Document Control
Green - 17025
Dk. Blue - 17025/Policies & ProceduresSlide50
4.4 - Review of Requests, Contracts, & Tenders
Green - 17025
Dk. Blue - 17025/Policies & Procedures
White - 17025/Records Slide51
4.5 - Subcontracting
Green - 17025
White - 17025/RecordsSlide52
4.6 - Purchasing Services & Supplies
Green - 17025
Dk. Blue - 17025/Policies & Procedures
White - 17025/Records
Lt. Blue - AOACSlide53
4.6 - Purchasing Services & Supplies (cont.)
Green - 17025
Lt. Blue - AOACSlide54
4.7 - Service to Client
Green - 17025 Slide55
4.8 - Complaints
Green - 17025
Dk. Blue - 17025/Policies & Procedures
White - 17025/RecordsSlide56
4.9 - Control of Non-Conforming Work
Green - 17025
Dk. Blue - 17025/Policies
& ProceduresSlide57
4.11 - Corrective Action
Green - 17025
Dk. Blue - 17025/Policies & Procedures
White - 17025/RecordsSlide58
4.12 - Preventative Action
Green - 17025
Dk. Blue - 17025/Policies & ProceduresSlide59
4.13 - Records
Green - 17025
Dk. Blue - 17025/Policies & Procedures
White - 17025/Records
Lt. Blue - AOACSlide60
4.14 - Internal Audits
Green - 17025
Dk. Blue - 17025/Policies & Procedures
White - 17025/RecordsSlide61
4.15 - Management Review
Green - 17025
Dk. Blue - 17025/Policies & Procedures
White - 17025/Records
Lt. Blue - AOACSlide62
5.2 - Personnel
Green - 17025
Dk. Blue - 17025/Policies & Procedures
White - 17025/Records
Lt. Blue - AOACSlide63
5.3 - Accommodation & Environmental Conditions
Green - 17025
Dk. Blue - 17025/Policies & Procedures
White - 17025/Records
Lt. Blue - AOACSlide64
5.4 - Test and Calibration Methods
Green - 17025
Dk. Blue - 17025/Policies & Procedures
White - 17025/RecordsSlide65
5.5 - Equipment
Green - 17025
Dk. Blue - 17025/Policies & Procedures
White - 17025/Records
Lt. Blue - AOACSlide66
5.6 - Measurement Traceability
Green - 17025
Dk. Blue - 17025/Policies & Procedures
Lt. Blue - AOACSlide67
5.7 - Sampling
Green - 17025
Dk. Blue - 17025/Policies & Procedures
White - 17025/Records
Lt. Blue - AOACSlide68
5.8 - Handling of Test Items
Green - 17025
Dk. Blue - 17025/Policies & Procedures
White - 17025/Records
Lt. Blue - AOACSlide69
5.9 - Assuring Quality of Test Results
Green - 17025
Dk. Blue - 17025/Policies & Procedures
White - 17025/Records
Lt. Blue - AOACSlide70
Additional PT Requirements
Green - 17025
Lt. Blue - AOACSlide71
5.10 - Test Results
Green - 17025
Dk. Blue - 17025/Policies & Procedures
White - 17025/RecordsSlide72
Typical FindingsSlide73
Only ISO/IEC 17025 accredited or applicant labs considered.There were a total of 7,800 cited deficiencies that was gathered from individual accreditation assessments of laboratories performed by A2LA over the last 4 years. Includes data for deficiencies against the clauses of ISO/IEC 17025, relevant test methods and specific program documents (e.g. AOAC Food Testing Requirements).
Criteria usedSlide74
Top ten Deficiencies represent over 75% of all types of Non-conforrmances (NCs).
67% are technical in nature. Rest are related to lab’s management system or A2LA policies.
10% of assessments have no NCs.
Average number per assessment = 7.
Deficiencies for All LabsSlide75
Laboratories were cited for deficiencies against ISO/IEC 17025, section 4.11 Corrective action.Not establishing a policy and a procedure or designating appropriate authorities
,Lacking an investigation to determine the root cause(s) and
Not monitoring the results to ensure that the corrective actions taken have been effective.
Tenth Most Cited DeficiencySlide76
Laboratories were cited for deficiencies against R103 – General Requirements: Proficiency Testing for ISO/IEC 17025 Laboratories. Lack details in documented proficiency plan.
PT results are not being provided within 30 days upon receipt; andFailure to meet the minimum proficiency testing participation frequency established.
Ninth Most Cited DeficiencySlide77
Laboratories were cited for deficiencies against ISO/IEC 17025, section 5.6: Measurement Traceability & A2LA P113 policy.Using non-accredited calibration laboratories.
Lack of accreditation body endorsement on calibration certificates. Improper reference standards for in-house calibrations.
Lack of procedures for the safe handling, transport, storage and use of reference standards/materials.
Eighth Most Cited DeficiencySlide78
Laboratories were cited for deficiencies against ISO/IEC 17025, section 5.9: Assuring the Quality of Test and Calibration Results.
Failure to participate in available and relevant commercial PT programs. PT Plan not complete or current and/or PT Schedule not being followed.
PT Data records incomplete.
Lack of quality control procedures /Failure to perform qc checks on accredited tests.
Lack of corrective action response to outliers.
Seventh Most
Cited DeficiencySlide79
Laboratories were cited for deficiencies against ISO/IEC 17025, section 4.14: Internal Audits.Inadequate
procedure.Lack records of findings. Not recording area of activity audited.
Failure to meet audit schedule.
No corrective actions for IA findings.
Not verifying continued compliance with all elements of their activities.
Lacking evidence of internal auditor training and qualified to perform the audit.
Sixth Most Cited DeficiencySlide80
Laboratories were cited for deficiencies against ISO/IEC 17025, section 5.5: Equipment.Equipment not uniquely
ID’ed/labeled with calibration status/calibrated before placed into service.Lacking records of calibrations & maintenance.
Defective/suspect equipment not sequestered.Intermediate checks not performed
after calibration, maintenance or repair.
Calibration cycles have been extended and not properly documented.
Fifth Most Cited DeficiencySlide81
Laboratories were cited for deficiencies against ISO/IEC 17025, section 4.13: Control of Records.Failure to record original observations.
Failure to retain adequate records to establish an audit trail.Procedures lacking all of the required record traceability requirements.
Inadequate protection of electronic records.
Records with information made illegible or scratched out and/or alterations to the records were not signed or initialed.
Fourth Most Cited DeficiencySlide82
Laboratories were cited for deficiencies against ISO/IEC 17025, section 4.3: Document Control.
Lacking defined control procedure.Documents not undergoing periodic review.
Use of obsolete/uncontrolled instructions.Failure to control external documents.
Master list of documents not current or complete.
Lacking record trail for archived documents.
Documents not uniquely identified and/or did not include all the required identification.
Third Most Cited DeficiencySlide83
Laboratories were cited for deficiencies against ISO/IEC 17025, section 5.4: Test (and Calibration) Methods and Method Validation.
Modification to method not validated.Method not confirmed prior to use.
Did not follow method procedure as written.
Measurement uncertainty: Improper or incomplete estimate. Lacking a procedure for estimation for in-house calibrations.
Failure to validate in-house software.
Second
Most Cited DeficiencySlide84
Laboratories were cited for deficiencies against Specific Program Requirements, such as AOAC requirements.Lacking records of yearly staff training on QMS.
No microbiological QC activities.Table 1 equipment calibration/ verification requirements not being followed.
Media records not complete.15% of the total were in areas specific to these.
#
1
Most Cited DeficiencySlide85
Questions / CommentsSlide86
Contact: Roger M. Brauninger
Phone: 301 644 3233
Email: rbrauninger@a2la.org
American Association for Laboratory Accreditation
5301 Buckeystown Pike, Suite 350
Frederick, MD 21704
www.a2la.org
For Further Information