ISO17025Accreditation/QualityManagementSystems

PanelDiscussion
 ManagementReview

PresentedbyTeresaGrant
NorthCarolinaDepartmentofAgriculture&ConsumerServices
Relevant section of the standard
4.2.2 Management System

4.10 Improvement

4.1.1 Corrective Action

4.13.1.1 Control of Records

4.15 Management Reviews

DuringthecourseofanannualManagementReview,thefollowinginformation
and/ordataispresentedforreviewanddiscussionasitcomplieswiththeISO/IEC
17025Section4.15.1. Thisinformationgenerallyincludesitemsasitpertainsto
ouraccreditingbody,customers,policies,qualitymanagementsystem,and
laboratorytesting.

Suitabilityofpoliciesandprocedures
Reportsfrommanagerialandsupervisorypersonnel
Recentinternalauditfindings
Correctiveandpreventiveactions
Assessmentsbyexternalbodies
Resultsofinterlaboratorycomparisonsorproficiencytests
Changesinthevolumeandtypeofwork
Customerfeedback
Complaints
Recommendationsforimprovement
Otherrelevantfactors,suchasqualitycontrolactivities,resourcesandstaff
training
Managementobjectives,goalsandactionplansforthecomingyear
ActionItems
Management Review Agenda
Attendees:

Changes to type and volume of work; future direction of FDPD Lab

Training plans, goals, objectives document individually in work
plans; matrix documenting ongoing competency and cross-training
also supports this.
Quality Objectives
Discussion of review topics (these need to include review of audit
findings not covered in Sept Management Review meeting refer to
report for specific audit topics to be covered)
1. Section 4.13 Control of Lab Records
a. General comments -
b. Internal audit results QA
2. Section 5.4.7 Protection of Electronic Data
a. General Comments
b. Internal audit results QA
3. Report on audit of QMS.023.004 QA
4. Additional discussions:
Management Review Agenda (continued)

Sample Rejections: 2/1/14-4/30/14

NCRs: 2/1/14-4/30/14
PARs: 2/1/14-4/30/14
PTs: 2/1/14-4/30/14
Status of Action Items from last meeting
Status of Internal Audits -
Status of Annual QMS Tasks (see end of Management
Review Planners)
Continuous improvement
 ManagementReviewAgenda(continued)

AssignmentsforNextMeeting:
ISOclause4.6(QMS.006)
ISOclauses4.7,4.8(QMS.007)
ISOclause4.13(QMS.011)

Related Action Item Assigned To Target Date Status

Clause

NEW ACTION ITEMS (Q4) 2014

Quality
Objective
 ManagementReviewOpeningComments Date
Budget
Totalspent
Totalavailable
Remaining
Saveforrepairs,incidental
expenses
Available

Staffing
Vacancies Status

Facilityupdates
LIMSupdates
Training Dates
Name of class Trainer Location Attendee
ManagementReviewPreparationPlanner
(TobecompletedbyQuality&ManagerialPersonnel)
Name: ______________________________
MeetingDate:__________________________
MeetingPreparation
ReadtheQMSprocedure(s)indicatedbycheckboxes.Inaddition,readthatsectionoftheQualityManual(FDPD
QMS.001)andtheISO17025/AOACGuidelines.UsetheCommentSectionsbelowtoaddresssuitabilityand
effectivenessforeachassignedtopic.UsethedropdownlistatthestartofeachCommentsectiontoidentifythe
topic.
AssignedTopics:
4.1Organization(QMS.002) 4.2Management
4.3DocumentControl(QMS.003) 4.4ReviewofRequests,Tenders,Contracts(QMS.004)
4.5Subcontracting 4.6PurchasingServices&Supplies(QMS.006)
4.7ServicetotheCustomer(QMS.007) 4.8Complaints(QMS.007)
4.9ControlofNonconformingTesting(QMS.009) 4.10Improvement(QMS.010)
4.11CorrectiveAction(QMS.009) 4.12PreventiveAction(QMS.010)
4.13ControlofRecords(QMS.011,QMS.019) 4.14InternalAudits(QMS.012)
4.15ManagementReview(QMS.013) 5.1General
5.2Personnel(QMS.014) 5.3Accommodation&EnvironmentalConditions&AOACAppx.B
(QMS.015&subordinates)
5.4TestMethods&MethodValidation 5.4.2SelectionofMethods(QMS.016)
5.4.35.4.5MethodValidation(QMS.018) 5.4.6EstimationofMeasurementUncertainty(QMS.017)
5.4.7ControlofData(QMS.019,QMS.025.001) 5.5Equipment&AOACAppendixA(QMS.020&subordinates)
5.6MeasurementTraceability 5.7Sampling
(QMS.021&subordinates)
5.8HandlingofTestItems(QMS.023) 5.9EnsuringtheQualityofTestResults(QMS.024&subordinates)
5.10ReportingtheResults(QMS.025) A2LAAdvertisingPolicy(QMS.026)
ManagementReviewPreparationPlanner(Continued)

QA RecordAnnualDocumentReview
CommentsSection
KeepinmindthedefinitionofEffective:Thedegreetowhich
objectivesareachievedandtheextenttowhichtargetedproblemsare
solved.
Chooseanitem
Isthepolicybothsuitableandeffective?Why/whynot?
Istheprocedurebothsuitableandeffective forourlab?Why/whynot?
[Note:thisismorethanjustanauditagainstISOortheQualityManual
doestheprocessinthisprocedureworkhere?Isittherightprocessfor
ourlab?]
Comments/correctionsfortheDRRlist(bespecific):
FeedbackandComplaintSummary
(2/1/14 4/30/14)
5 0newrecordsinDatabase

4
HowmanyledtoNCR?0
HowmanyledtoPAR?0
3 Howmanywerepositive?0
Complaints?0
2
Inquiries?0
1

unsolic. complaint solic. inq.

 Total Audit Self

NCRsbyLab Food
NCRs
3 0
Report
2
(2/1/14 4/30/14) Pest 2 1 1
Micro 5 0 5
Feed 3 0 3
10 Fert. 6 0 3
9 QA 3 0 2
8 LW 3 3 0

7
Total=include#alreadyopen;
6 Audit/SelfReport=#initiated
duringthistimeperiod
5 Incor.Data
4 Supplies
3 Eqp
Contam.
2 QC
1 Customer
0 PT
Food Pest. Micro Feed Fertilizer QA LW Doc
 PARs
(2/1/14 4/30/14)
Section #Total PARs Topics Recordnumbers
submitted

Fert 2 Xxxxxxx 14133;14136

yyyyyyy
Food 1 zzzzzzzzz 14139

Micro 1 aaaaaaaa 14129

PestRes 0

Feed/Forage 2 Bbbbbbb 14134;14138

cccccccc
QA 1 ddddddd 14135

LW 2 Eeeeeeee 14128,14131,
ffffffffffffffff
 SampleDispositionRecords
TotalsbyCustomer
(2/1/14 4/30/14)

20 Reason for # Entries for

Entry that Reason
TotalEntries=47
Sample # or # 1
15 Rejects=19 subs does not
match
transcript
10 Leaking/ 6
spilling

5 Insufficient 7
amount
Security seal 2
0 broken
Other 31

TotalSampleEntries SamplesTested
 PT Summary
(2/1/14 4/30/14) Results back from Provider)
[Analytes counted multiple times if they appeared in multiple PTs]

40
35
30
25
20 #PTs
#Tests
15
10
5
0
Food Pest. Micro Feed Fert Form
 ZscoresbyLabSection
(2/1/14 4/30/14)
25

20

15
Feed
Food
10
Fertilizer
Micro
5

5
 FeedProgram LaboratoryCustomerMeeting
Date,2014
Attendance:
Emaildistribution:
1]BSEGrant
SampleCollection&Testing
AAFCOmeeting
2]Contracts reviewedeverytwoyears FeedMarch2014
3]LIMSReports
4]Receiving
SampleDispositions(fromthelabs database)1/17/142/9/14nonetoreport
SD# Date Sample# SampleDescr. Problem Tested?Y/N

5]OtherSampleIssues
AdditionalDiscussion:
ActionItemsandAssignments fornextmeeting:
Completeupdatestocontractsduringmeeting.

Actionitem Assignedto Duedate Completed

 Technician
KRR ISO17025AccreditationMaintenanceandContinuousImprovement[QMSDocumentation,Non
Conformities,CorrectiveActions,PreventiveActions,Audits]
G Supportcontinuousimprovementbyidentifyingatleast1idea[includesideaspassedalongfrom
supervisororotherlabstaff].
Examplesofideasinclude:
improvethequalitymanagementsystem;
improveunderstandingorinterpretationofqualitydocumentation;
submitanddeveloppreventiveaction[PAR]suggestions
maximizeefficientandeffectiveuseofpersonnel,equipmentorlabspacebyoptimizinguseof
personnelworkhours,increasingruntimeonequipment,alteringlabspace,movingequipment;
minimizetestingturnaroundtimethroughidentifying,investigatingandaddressingthecauseof
bottlenecks,delaysordisruptiontoworkflow;
improvesupporttocustomer;
reducecostoftesting[consumables,chemicals,standards,kits,glassware,optimizedbatching,
etc]
reducecostofequipmentmaintenance
improvesafety
VG SupportcontinuousimprovementbyassistingSupervisororassignedteamwithplanningand/or
implementingsectionideas.
O VGplusSupportcontinuousimprovementbyidentifyingatleast2ideas[includesideaspassed
alongfromsupervisororotherlabstaff]andassistingSupervisororassignedteamwithplanning
and/or implementingsectionideas.
 Technician
KRR Training
G CompletetrainingasrequiredperFDPDQMS.014Trainingand
Competence,
attendscheduledtrainingsessions,
completereadingassignmentsperDocumentTransmittalNotices
[DTN]fromQA,
maintainpersonaltrainingdatabaseand
completerequiredDemonstrationsofCompetence.
Nomorethan2incidencesofnotattendingscheduledtraining
sessions,completingreadingassignments,maintainingtraining
matrix,completingDemonstrationofCompetenceorcompleting
QMSorlabsectiontrainingrequirements.
Attendedothertrainingasassigned,suchasvendortraining.
Aftertrainingopportunities/classesarecompleted,mustsubmita
briefreportdescribingthetakeawaypointstosupervisor
KRR Training(continued)
VG Goodlevelplusconductstrainingofothersasassignedby
supervisororQA.
Nomorethan1incidenceofnotcompletingQMSorlabsection
trainingrequirements.
Proactivelyseeksonetechnicaltrainingopportunitiesfromthe
following
vendorclassesorwebinars
association,governmentorothersponsorclasses
onlinetraining
readsabook
reads2ormorearticles=1training
[allaboveoptionsmustbeapprovedbySupervisor]
Aftertrainingiscompleted,mustsubmitabriefreportdescribing
thetakeawaypointstosupervisor
KRR Training(continued)
O VeryGoodlevelplusvolunteerstotrainothersordevelop
sectionsforthelabsectiontrainingmanualorotherexampleof
proactivecontributiontolabtrainingprogram.
NoincidencesofnotcompletingQMSorlabsectiontraining
requirements.
Proactivelyseekstwotechnicaltrainingopportunitiesfromthe
following
vendorclassesorwebinars
association,governmentorothersponsorclasses
onlinetraining
readsabook
reads2ormorearticles=1training
[allaboveoptionsmustbeapprovedbySupervisor]
Aftertrainingiscompleted,mustsubmitabriefreportdescribing
thetakeawaypointstosupervisor.