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Copyright ILAC 2002

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Guidelines for the

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ILAC Publications

Guidelines onGrading ofNon-conformities

ILAC-G20:2002

ILAC-G20:2002

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Guidelines on Grading of Non-conformities

PREAMBLE

A new work item, which was approved at the 1998ILAC General Assembly, was to investigate thequestion of the grading of non-conformities oflaboratories by accreditation bodies. Dr MaxRobertson was asked to lead the enquiry that wasto be aimed at determining the degree of consis-tency amongst accreditation bodies and, if neces-sary due to lack of consistency, to prepare anILAC guidance document on the subject.

A questionnaire was prepared and approved at theILAC Technical Accreditation Issues Committee(TAIC) meeting in mid 1999 and was sent out toILAC members. All those that replied except onehad some form of grading although many gradingsystems related to the various actions that theaccreditation body would take to correct thevarious non-conformities rather than clearlydefined categories of grading. Only one accredita-tion body had clearly defined A, B, C etc gradingcategories. There was no obvious consistency ingrading amongst the various replies. The onewithout any grading considered that allnonconformities were serious.

At the October 1999 meeting of the TAIC thedecision was, Given the responses to the enquiry,it is clear that this subject needs attention. It isconcluded that a guidance paper should be pre-pared with the aim of harmonising the grading ofnonconformities. The 1999 ILAC General Assem-bly decided, TAIC is requested to further developguidelines for dealing with non-conformities.

The guidance in this document is based on themethods of grading of the majority of accredita-tion bodies. However, when judging whether anindividual laboratory or its staff members arecompetent, the personal professional judgement ofthe technical assessors, supported by qualitycontrol results such as reference material results orproficiency testing results, will determine theseriousness of any particular non-conformity andthe actions which the accredited laboratory shouldtake.

PURPOSE

This document outlines one approach to gradingnon-conformities, from more to less serious,through linking the seriousness of the nonconfor-mity with the actions that the accreditation bodymay need to take. Some examples of the variousgradings are listed.

AUTHORSHIP

This document has been produced by the ILACTechnical Accreditation Issues Committee.

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Guidelines on Grading of Non-conformities ILAC-G20:2002Table of Contents

Preamble ................................................................................................................................................ 4

Purpose ................................................................................................................................................... 4

Authorship .............................................................................................................................................. 4

1 NATURE OF NON-CONFORMITIES .................................................................................... 6

2 ACTIONS TAKEN BY ACCREDITATION BODIES AS ACONSEQUENCE OF NON-CONFORMITIES ...................................................................... 6

3 GRADING THE NON-CONFORMITIES ............................................................................... 7

4 GENERAL COMMENTS ON GRADING OF NON-CONFORMITIESAND ISSUING OF CORRECTIVE ACTION REQUESTS ..................................................... 8

APPENDIX: Examples of Non-conformities Which may be Allocated to the Various Gradings .... 9

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1 NATURE OF NON-CONFORMITIES

For quality management system certifica-tion, the specified standard defines what isrequired. If during an audit, requirements inthe standard are found to be not in place inthe documentation, then non-conformityhas occurred and a corrective action requestwill be raised. Further, if the laboratorystaff members are not performing theirtasks in accordance with the documentedprocedures this will also be regarded as anon-conformity. These decisions are usuallyquite objective.

For accreditation of laboratories, one aspectof the assessment is to ensure, as withcertification, that the management system isin conformance with the standard and thatstaff members are following the procedures.However, the key aspect of the assessmentis the determination of competence ofstaff and the technical validity of theoperations. This assessment (not audit)process requires the professional judgementof the technical assessors and / or experts.Where it is considered that key technicalmanagers or other key staff are not compe-tent or where the technical validity of thetesting or calibration work is in question, anon-conformity with one or more of thetechnical elements of the standard (ISO /IEC 17025) will need to be raised.

For accredited laboratories there is anothertype of non-conformity that must also beconsidered. The accreditation body will haverules and requirements that its accreditedlaboratories must follow. These rules mayinclude, inter alia, claims of accreditationstatus or use of the accreditation mark.Where these rules have been broken, theaccreditation body will also raise a non-conformity.

Thus for accreditation the nature of non-conformity may be:

! documentation not conforming withthe requirements of the standard

! staff are not following documentedprocedures

! technical managers or other key staffnot demonstrating competence in thework they are doing

! operational procedures such as testor measurement methods, traceabil-

ity, etc., lacking technical validity! a breakdown in the operation of the

quality management system of thelaboratory

! the laboratory not conforming to therules of the accreditation body.

In deciding which non-conformities are soserious as to require immediate suspension,which are serious enough to require promptattention and the presentation of objectiveevidence to the accreditation body, andwhich are minor and may be checked out atthe next assessment, the accreditation bodywill need to take into account the nature ofthose non-conformities.

Because accreditation is primarily concernedwith providing assurance to the customersof laboratories that their staff are compe-tent and their procedures and results aretechnically valid, then non-conformitiesrelated to technical activities would normallybe viewed as more serious than non-conformities related to the managementrequirements where the validity of resultsmay not be in question (note that someelements in section 4 of ISO/IEC 17025are technical elements). However, manage-ment requirement non-conformities thatjeopardise the whole quality system of thelaboratory would also need to be regardedas serious.

The following outlines one approach tograding non-conformities, from more to lessserious, through linking the seriousness ofthe non-conformity with the actions that theaccreditation body may need to take. Someexamples of the various gradings are listed.

2 ACTIONS TAKEN BYACCREDITATION BODIES AS ACONSEQUENCE OFNON-CONFORMITIES

Laboratory assessors will all be aware thatfollowing an assessment, a significantpercentage of laboratories fall short of (donot conform with) accreditation require-ments. These laboratories are issued withNon-conformity Notices or CorrectiveAction Requests (CARs) which define thenature of the non-conformity and whichrequest / require corrective action by aspecified date.

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For non-accredited laboratories undergoingtheir initial assessment it is normal to delayaccreditation until corrective actions havebeen effectively implemented to the fullsatisfaction of the assessment team. How-ever the assessment team may propose thatCARs based on minor non-conformitiesmay be cleared after the accreditation.Corrective actions based on serious non-conformities must be done before accredi-tation.

For laboratories already accredited, thequestion of seriousness of non-conformitywill arise. For example, should a date leftoff one page of a document (non-conformity in document control) be re-garded in the same light as a series ofsignificant outliers in the proficiency-testingprogramme, which have not been followedup, or as the loss of the only staff member(signatory) who was found to be competentby the accreditation body to do that particu-lar work?

The accreditation body may require thatsome non-conformities are corrected moreurgently than others and that objectiveevidence of the laboratorys correctiveactions are provided and that clients areadvised where results are in question. Ifnon-conformities are really serious, accredi-tation may need to be suspended immedi-ately.

These varying consequential actions of theaccreditation body amount to grading ofnon-conformities.

A typical grading of the seriousness of non-conformities, based on the actions taken bythe accreditation body, may be:

1) Where non-conformity is veryserious indeed and the credibility ofthe accreditation programme isseriously threatened, the accreditationof the laboratory or the affectedtests / measurements is suspendedimmediately.

2) Where non-conformity is quitesignificant, corrective action mustbe completed within the specifiedtime interval to avoid suspension.Such non-conformities may well

need a follow-up on-site assessment toensure they have been effectivelycorrected especially if the validity ofresults or the integrity of the accredi-tation body is threatened. However, ifthe assessment team agrees that thelaboratory understands the issues,written assurance of corrective actionand the provision of objective evi-dence of the measures taken, may beacceptable.

3) Where the non-conformity is minor orisolated and does not affect test orcalibration results or certificates,requiring corrective action would notimprove the operations of the labora-tory and could seriously damage therelationship between the laboratoryand the accreditation body. In suchcases the non-conformity could benoted in the assessment notes, forchecking at the next assessment butno request for corrective actionshould be made.

By starting with the actions that the accredi-tation body requires of the laboratory, whenit identifies a non-conformity, we havedefined three grading categories for non-conformities.

Forms of grading similar to this but withvarious numbers of categories were the mostcommon for accreditation bodies that repliedto the ILAC enquiry.

3 GRADING THENON-CONFORMITIES

During the private analysis meeting of theassessment team, they may have identified anumber of non-conformities and theirnature as described in Section 2.

Identifying the nature of a particular non-conformity may be helpful in deciding themost appropriate grading from Section 3.

For example, technical requirements non-conformities that are threatening the validityof test or measurement results would usuallybe regarded as at least quite significant andpossibly very serious indeed (grades 1 or 2above). Similarly, a serious breakdown in the

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quality management system, such as manycomplaints being received but noneactioned, may be in the serious category.

Apparently intentional breaching of therules for the use of accreditation body logoor mark may also be regarded as veryserious indeed. This would be the caseparticularly if the integrity of the accredita-tion body or unfair competitive advantageagainst properly accredited organisationshad resulted.

Some management system element non-conformities may be graded as 2 or 3depending on the situation. A 3 grading mayresult if the validity of results were not inquestion and the management system wasnot in jeopardy. However, there are caseswhere failures in elements of the manage-ment system may be serious and warrant a1 grading.

In some cases a series of non-conformities,each in them selves being minor, may addup in combination to what is considered aserious overall problem in the laboratory.

Regardless of the nature of the non-conformities, each one should be evaluatedwithin the circumstances presented so that afair grading may be established and theactions taken against the laboratory will beappropriate.

To maximise the usefulness of this docu-ment, ILAC members have providedexamples of non-conformities that may leadto each particular grading. These are pre-sented in the appendix. The suggestedgradings are for guidance only. Had the fullcircumstances been presented, a differentgrading may have been more appropriate.

It must be emphasised that apparentlysimilar situations may result in differentgradings. This is because no two circum-stances are exactly the same and the conse-quences of the particular non-conformitymay be very different.

Because the evaluation of staff competenceor technical validity is not entirely objective,different gradings may result in similarsituations. The accreditation body shouldtake all steps possible to minimise theseinconsistent outcomes.

Where a grading decision is marginal, thetrack record of the laboratory with itsaccreditation and the degree to which theaccreditation body trusts the body to takeprompt and effective corrective action mayresult in the downgrading of the seriousnessof the non-conformity.

4 GENERAL COMMENTS ONGRADING OF NON-CONFORMI-TIES AND ISSUING OFCORRECTIVE ACTION REQUESTS

Grading of non-conformities should bebased only on the findings recorded duringthe assessment.

Grading decisions should be made by theassessor and lead assessor who were on site.They should be made at or soon after thevisit.

A finding should be sufficiently detailed tobe able to confirm whether it was a one-time event or a general statement whosecorrective action should be implementedthroughout the laboratory. It is the responsi-bility of the laboratory to determine,through its corrective action procedure, if aone-time event may have wider implications.A corrective action request may ask thelaboratory to itself determine if the findingindicates a chronic problem.

Minor non-conformities, which are to bechecked at the next assessment, may bereported verbally to the laboratory, mayperhaps be included in the report andshould be recorded in the assessment notes,so that the laboratory manager understandsthat they will be checked during the nextassessment.

Minor non-conformities have a tendency togrow into significant non-conformities ifnot addressed appropriately at the time.

Where a non-conformity is found, theassessor(s) should evaluate its affect on thequality of the results of the laboratory. Forexample, an uncorrected error from thecalibration of a thermometer used in atesting laboratory may have little effect onthe results if that test is not particularlytemperature sensitive.

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In all cases of non-conformity, assessorsmust resist approving proposed correctiveactions presented on the day of the assess-ment without a proper corrective actioninvestigation by the laboratory. Such ap-provals may lead to the embarrassment ofhaving to issue another CAR at the nextassessment because the approved correc-tive action was not adequate.

Findings should be evaluated together withthe general picture / history of the labora-tory e.g. trust, ongoing improvement, staffcompetence, repetitive nature (from previ-ous assessments), etc.

Where urgent suspension of a laboratory isindicated after the identification of veryserious non-conformities, procedures forimmediate suspension are necessary ratherthan awaiting the next meeting of a commit-tee.

APPENDIX:Examples of Non-conformities Which may beAllocated to the Various Gradings

It must be emphasised that had more detailedinformation been available to the authors of thispaper about the real situation, a different gradingmay well have been given.

Many quality management system deficiencies arepossible but these are usually addressed during theinitial assessment and must be corrected and closedout prior to accreditation being granted. Such non-conformities are not included in the examplesbelow as they are seldom an issue for a laboratoryalready accredited.

1 Non-conformities that could lead to imme-diate suspension of accreditation or of theaffected scope of accreditation.

1.1 The laboratory has lost its key technicalmanager(s) for particular work and nolonger has competent staff doing that work.They continue to issue test / calibrationreports in that field. They did not advise theaccreditation body nor did they self suspendtheir accreditation.

Result: Suspension for that particular workuntil a new technical manager has beenfound to be competent by the accreditationbody e.g. interviewed by a technical assessor.

1.2 After two previous warnings the laboratoryis still issuing test / calibration reportsendorsed with the accreditation body logowith results (not marked accordingly) whichare outside the scope of its accreditation.

Result: Withdrawal or general suspensionuntil there is a serious commitment tofollowing accreditation rules and a proce-dure and monitoring are implemented,which convince the accreditation body thatit will not happen again. (see ILAC G 14:2000 on use of accreditation body logos)

1.3 Key equipment for particular work hasfailed and cannot be fixed or replaced in theimmediate future. The laboratory is notsubcontracting the work to another accept-able laboratory and is issuing test / calibra-tion reports even though the alternativeequipment being used is not technicallyvalid.

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Result: Suspension for that particular workuntil suitable equipment is commissioned tothe satisfaction of the accreditation body orthe work is temporarily sub-contracted toanother laboratory accredited for suchwork.

1.4 The accommodation is such that it isimpossible for laboratory staff to preventserious cross contamination of samples.

Result: Suspension of that testing until anon-site visit confirms that accommodationhas been altered to resolve the problem anda monitoring programme has been estab-lished to demonstrate that its facilitiesremain under control.

1.5 The laboratory has identified a serious errorin a calibration record that impacts on testresults. This has not been corrected andclients have not been notified of erroneousresults, which they have received.

Result: This part of the laboratorys work issuspended until the equipment has beenproperly recalibrated and commissioned andearlier work that was affected has beenrecalled and dealt with. (If the error can becorrected directly, suspension may not benecessary but a cause analysis would beappropriate to prevent recurrence.)

1.6 There are no current dates of calibration ofequipment in the equipment records andtherefore it is impossible to verify thecalibration status of the equipment. Further,the maintenance programme and mainte-nance records cannot be located. In additionthere are no records of which referencematerials / standards were used for particu-lar equipment calibrations.Result: The laboratory would be suspendedimmediately. Such a situation would indicatethat something had gone seriously wrongsince the last assessment.

1.7 There are no records of action taken on anoutlying result of a proficiency test. Thereare no records of any corrective actions.There was speculation amongst laboratorystaff that an incorrect standard was usedbut this was not followed through. Itappears that other QC data is not moni-tored or acted upon.

Result: The laboratory is immediatelysuspended for this particular work until aproper investigation has been completedand suitable corrective action taken todemonstrate that the test is under control,and records of this properly kept.

1.8 The laboratory has no uncertainty budgetfor a particular calibration, which it hasimplemented since the last assessment andhas been claiming accreditation for.

Result: This work would be suspendedimmediately until the accreditation body wassatisfied that a proper uncertainty budgethas been presented. The laboratory wouldalso receive a serious warning about themisuse of its accreditation status.

1.9 The results of a calibration inter laboratorycomparison shows an En value greater than1 and there is no record or explanation ofthe laboratory having followed up on thispotential problem.

Result: The laboratory is immediatelysuspended for this particular calibrationwork until effective follow-up action hasbeen demonstrated.

1.10 The calibration / testing laboratory cannotlocate its list of its reference standards andit is not clear which items are being used asreference standards.

Result: The laboratory is suspended untilevidence is forthcoming that it has sortedout its reference items and has properrecords of the whole measurement trace-ability process.

1.11 A new in-house procedure has been devel-oped for one particular accredited test. Theprocedure has not been validated and thereis no evidence that it is giving the sameresults as the reference method. Thelaboratory is claiming accreditation for thisprocedure.

Result: The accreditation for that test isimmediately suspended until full methodvalidation is completed to the satisfaction ofthe accreditation body.

1.13 There is significant evidence that the qualitymanagement system is seriously failing. The

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laboratory has not conducted an internalaudit for over 18 months (just before thelast assessment, which is not according itsown procedure. Also staff members indi-cate that many customer complaints arebeing received by telephone and sent to theappropriate person by e-mail but there arenone recorded in the complaints file, andthey are not acted upon.

Result: The laboratorys accreditation issuspended until there has been an internalaudit and a management review and afurther on-site assessment indicates that thesystem is again in effective operation.

2 Non-conformities that would require proofof implementation of corrective actionwithin a specified time interval.

2.1 Some critical equipment has passed itsscheduled calibration date and has not beenrecalibrated. Daily or as used checksindicate that the equipment continues tomeet specifications.

2.2 A recent Proficiency Testing result was anoutlier and corrective action has not yetidentified or effectively corrected theproblem.

2.3 A standard method has been altered withoutthe clients prior approval and withoutvalidation of the alteration. (More informa-tion would be needed to determine thesignificance of this which may be moreserious than indicated)

2.4 The accommodation is not being keptsufficiently clean and tidy for the detailed ortrace or micro work being done. However,quality control data or environmentalmonitoring indicate that test results shouldnot have been affected to date.

2.5 An advertisement is implying accreditationfor a wider range of work than is coveredin the scope.

2.6 The internal auditing programme is twomonths overdue. Two items from the mostrecent one have not been followed up orclosed out.

2.7 This years management review has notbeen done.

2.8 Some items of volumetric glassware andone thermometer have not been calibrated.(The significance of this will depend on thecontribution these measurements make tothe uncertainty of the results).

2.9 There are some errors in the transcriptionof the standard method to the laboratorymethods manual.

2.10 Competency records of some technicalstaff do not confirm that they are compe-tent to do what they are doing in relation toaccredited work. (If this is more than arecords problem it may be more seriousthan indicated.)

2.11 There is no procedure for control ofnonconforming work (or recall of incorrectreports)

2.12 Some of the procedures or operations fordocument control, for updating the qualitymanual, for distribution of changed test andcalibration methods or amending documentsare not complete and/or are not beingfollowed.

2.13 The laboratory has no record of delivery oflast years training programme. Also, there isno evidence of last years performanceappraisals and training needs identification.The internal audit did not identify theseproblems.

2.14 The uncertainty budget is not fully in linewith EA 4/02 or GUM or equivalent butthe calculated values of the measurementuncertainty are not smaller than expectedvalues.

2.15 In one procedure there was a requirementfor the engineer to visually check the cubesfor defects but no criteria were given forrejecting them.

3 Minor non-conformities that:! are reported as such and will be

followed up at the next assessment or! are indicated to the laboratory and

are not reported in the written reportbut they are noted in the files forchecking at the next assessment.

Some of the following examples, althoughapparently minor, may indicate wider

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underlying problems, which need to beaddressed.

3.1 A photocopy of an obsolete procedure wasfound in the drawer of one of the analysts.

3.2 One customer complaint had been actedupon but not been closed out.

3.3 One staff member had no job personaldescription although there was a genericdescription for those in that position in themanual.

3.4 The document control procedure of thelaboratory requires that every page of eachprocedure manual is to be signed off by thetechnical manager. The team finds twopages of one procedure that have not beensigned off. Other pages appear to have beencorrectly signed.

3.5 A new technician tells an assessor that shehad one customer complain about the factthat a report was one day late. She told hersupervisor but did not fill out the appropri-ate corrective action form as she consideredthe complaint to be frivolous. Other com-plaints seem to be recorded and acted uponproperly.

3.6 In the back of a cupboard full of volumet-ric glassware, an assessor finds one standardflask that has not been calibrated. It hasdust on it indicating that it has not beenused for some time as others nearer thefront are all sparkling clean. Other volumet-ric glassware in the laboratory appears to bein order.

3.7 A label has fallen of a standard stocksolution and is lying beside the bottle in thecupboard. The record of its standardisationis in order assuming that the label matchesthe bottle. Other labels are intact.

3.8 One of the dates in the sample receptionnotebook was incomplete in that only themonth and year were recorded.

3.9 A reference standard was not calibrated bythe due date but no calibrations had beenperformed based on this item, after thatdate and until it was again recalibrated.

3.10 Additional equipment, that does not signifi-cantly influence the measurement results or

the uncertainty, is being used but is notlisted in the equipment records of thelaboratory.

3.11 The value of a measurement uncertainty iswritten using ppm rather than 10-6 in thecalibration records (but not in the calibra-tion certificate).

The International Laboratory Accreditation Cooperation (ILAC) is the principal international forum for the exchange of ideas and information on laboratory accreditation.

Established in the late 1970s, ILAC membership has grown rapidly and includes representatives from the worlds major laboratory accreditation systems in Europe, Asia, North America, Australia and the Pacifi c. Countries that are developing their own laboratory accreditation systems are also welcome to participate and contribute.

ILAC operates a series of committees which investigate issues such as the harmonisation of international laboratory accredi-tation practices, the effectiveness of mutual recognition agreements in facilitating trade and the promotion of the aims and awareness of laboratory accreditation around the world.

There are regular meetings of individual ILAC committees as well as a major plenary meeting of all ILAC members.

The activities of ILAC affect a diverse range of areas including standardisation, accreditation, certifi cation, testing, calibration, and regulation in both the public and private sectors.

ILAC has a comprehensive website at www.ilac.org which contains a wealth of information regarding accreditation, testing, trade related publications and other information of interest to industry, regulators, government, trade bodies, laboratories,

accreditation bodies, and users of testing and calibration services.

The following ILAC publications are available free of charge on the ILAC website at www.ilac.org:

BrochuresILAC Information BrochureWhy Use An Accredited Laboratory?Why Become An Accredited Laboratory?How Does Using an Accredited Laboratory Benefi t Government & Regulators?The Advantages of Being An Accredited Laboratory (86 kb) Information Documents (I Series)ILAC-I1:1994 Legal Liability in TestingILAC-I2:1994 Testing, Quality Assurance, Certifi cation and AccreditationILAC-I3:1996 The Role of Testing and Laboratory Accreditation in International TradeILAC-I4:1996 Guidance Documents for the Preparation of Laboratory Quality Manuals

Guidance Documents (G Series)ILAC-G2:1994 Traceability of MeasurementILAC-G3:1994 Guidelines for Training Courses for AssessorsILAC-G4:1994 Guidelines on Scopes of AccreditationILAC-G7:1996 Accreditation Requirements and Operating Criteria for Horseracing LaboratoriesILAC-G8:1996 Guidelines on Assessment and Reporting of Compliance with Specifi cationILAC-G9:1996 Guidelines for the Selection and Use of Certifi ed Reference MaterialsILAC-G10:1996 Harmonised Procedures for Surveillance & Reassessment of Accredited LaboratoriesILAC-G11:1998 Guidelines on Assessor Qualifi cation and CompetenceILAC-G12:2000 Guidelines for the Requirements for the Competence of Reference Material ProducersILAC-G13:2000 Guidelines for the Requirements for the Competence of Providers of Profi ciency Testing SchemesILAC-G14:2000 Guidelines for the Use of Accreditation Body Logos and for Claims of Accreditation StatusILAC-G15:2001 Guidance for Accreditation to ISO/IEC 17025ILAC-G17:2002 Introducing the Concept of Uncertainty of Measurement in Testing in Association with the

Application of the Standard ISO/IEC 17025ILAC-G18:2002 The Scope of Accreditation and Consideration of Methods and Criteria for the Assessment of the

Scope in TestingILAC-G19:2002 Guidelines for Forensic Science LaboratoriesILAC-G20:2002 Guidelines on Grading of Non-Conformities

Secretariat Documents (S Series)ILAC-S1:2000 Guidelines for the Proposal, Drafting, Approval and Publication of ILAC DocumentsILAC-S2:1998 Rules

Procedural Documents (P Series)ILAC-P1:2000 ILAC Mutual Recognition Arrangement (Arrangement): Requirements for Evaluation of Accreditation

BodiesILAC-P2: 2000 ILAC Mutual Recognition Arrangement (Arrangement): Procedures for the Evaluation of Regional

Cooperation Bodies for the Purpose of RecognitionILAC-P3: 2002 ILAC Mutual Recognition Arrangement (Arrangement): Procedures for the Unaffi liated Bodies for the

Purpose of Recognition ILAC Mutual Recognition Arrangement (Arrangement): Terms of Reference and Composition of the

Arrangement Management Committee ILAC Mutual Recognition Arrangement (Arrangement) ILAC Mutual Recognition Arrangement (Arrangement): Policy Statement

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