WELCOME INAB ASSESSOR FORUM 22 nd and 29th January 2008.

WELCOME

INAB ASSESSOR INAB ASSESSOR FORUMFORUM

22nd and 29th January 2008

Role of INAB and INAB Accreditation

Tom Dempsey

INAB Assessor Forum

Welcome

Thanks to the INAB Assessors

Agenda and Programme

Purpose and objectives of Assessor Forum

Key issues for Assessor Forum

Background to INAB

Agenda and Programme

10.05 Role of INAB and INAB Accreditation11.00 Break – Coffee/tea11.15 Assessing Competence12.45 Lunch14.00 Aspects of the Assessment Process14.45 New Developments15.30 Break – Coffee/tea15.45 Administration issues (Invoicing, Fees etc)16.00 Final Discussion

Close of Workshop

Key issues for the Assessor Forum

Exchange of information Role of INAB assessment team/Board etc. Harmonisation of assessment process Results of INAB Client Survey Focus on Assessing competence Specific aspects of assessment process New Developments-internal and external Administration issues (invoicing, fees, etc.)

INAB Background

Established in 1985 - permanent staff 13

Independent Board with expert committees

70 contracted technical experts/assessors

125 Accredited Organisations

Annual Running Costs €1.7m

Department of Enterprise, Trade and Employment

ForfásThe National Policy and Advisory Board

for Enterprise, Trade, Science, Technology & Innovation

The Irish National Accreditation Board

Board Of INAB 12 BoardMembers

INAB ExecutiveStaff of 13

INAB Board – Current Board MembersDr Maire C. Walsh Former State Chemist, Chairperson

Mr Tom Dempsey Manager INAB

Dr Nuala Bannon Inspector, Department of Environment, Heritage and Local Government

Mr Tom O’Neill Site Leader, Pfizer Little Island API manufacturing Plant

Dr Fiona Kenny Consultant Microbiologist, Sligo General Hospital

Mr Martin O’Halloran CEO Health and Safety Authority

Mr Richard Howell Agriculture Inspector, Department of Agriculture and Food

Mr Neil McGowanRegulatory Affairs Executive, Food and Drink Industry, IBEC

Mr Michael Maloney Director of Horticulture, Bord Bia

Mr Vagn Andersen Manager of International Affairs, Danish Accreditation Body (DANAK)

Mr Pat O’Mahony CEO, The Irish Medicines Board

Dr John O’Brien CEO, Food Safety Authority of Ireland, FSAI

Irish National Accreditation Board

Tom Dempsey

BridBurke

AdrienneDuff

PatO’Brien

MarieO’Mahony

James Stapleton

Orla Doyle

AnnaStepien

KaterinaAsprou

AndrewStratford

Frank Crowe

EmmaScott-McGrane

SineadGuckian

Accreditation of organisations in accordance with European and International Standards

Statutory monitoring body for OECD/EU GLP (Good Laboratory Practice) regulations - S.I. No. 4 of 1991 and S.I. No. 294 of 1999

Competent Authority for:

EMAS ( Council Reg. 761/2001)

Carriage of Dangerous Goods by Road (S.I. 290/2007)

Maintenance of EA and ILAC Multilateral Agreements membership which provides international recognition

Participation at European/International level in developing accreditation policy and criteria

Key Roles

Irish National Accreditation Board

Services

Accreditation of Medical Testing

LaboratoriesISO 15189

Accreditation of Calibration and Testing

LaboratoriesISO 17025

Accreditation of Certification Bodies

EN 45011, 12,ISO 17024

ISO Guide 66 E-Signatures

Directive

Accreditation and Supervision of EMAS Verifiers-

Council Reg. No. 761/2001

Accreditation of Attestors/

Attestation Bodies

for PublicProcurement

EN 45503

Accreditation of Inspection

BodiesISO 17020

Competent Body EMAS EU Scheme

Council Reg. 761/2001

Enforcement of GLP (Good Laboratory Practice) Requirements S.I. No. 4 of

1991 as amended by S.I. No 294 of 1999

Competent AuthorityCarriage of Dangerous

Goods by RoadS.I. No. 290 of 2007

Role of INAB Assessment Team/Board etc.

Assessment team Assesses competence and not just

conformance

Provides professional judgment

Raises factual non-compliances

Makes recommendations but not decisions on accreditation


INAB Officer Manages portfolio of organisations Represents INAB on Assessment team Communicates and Interprets INAB

policy Monitors assessment process Safeguards harmonisation


INAB Board and Manager

Considers assessment team recommendations

Decides on accreditation

Decision making Process

Decisions made by the INAB Board:

New Accreditations Granted

Extensions to Scope in a new area Termination of Accreditation

Decisions made by the Manager:

Extensions to Scope in the same field

Suspension of Accreditation

Decision making ProcessDecisions made by the Board 6 – 7 Meetings held annually

ALL non-compliances to be cleared before recommendations submitted to Board

Report prepared by INAB Officer to include:

Summary of assessment process

Proposed Scope of Accreditation

Forms: Summary & Recommendation- F118

Assessment Trail – F116

Clearance of Non- compliances – F121

Circulated to Board 1 week before meeting INAB Officer presents report to Board

Harmonisation of Assessment Process

Background

Worldwide several surveys identify harmonisation as an issue.

One standard for accreditation depending on conformity assessment activity

Internationally harmonised interpretation documents.

Assessors trained in assessing to relevant accreditation standard

International monitoring of Accreditation Bodies.

Perception

Different assessors impose different requirements

Different assessors impose conflicting requirements



Areas where inconsistent interpretations are perceived

Laboratories Detail required for method validation Expectations for estimation of uncertainty of

measurement Media QC requirements Temperature control requirements Attitude to participation in PT schemes


Areas where inconsistent interpretations are perceived

General Variation in content of Quality Manual Variation in number of assessor days

Scope of accreditation – generic vs. specific

Variation in approach to assessments

Training requirements


Areas of Concern for Certification Bodies

Accreditation is too expensive CBs want the Accreditation Yesterday CBs want to influence the decision making process

Why inconsistencies may occur

Interpretation of the Standard is required

Assessors are human and may have hobby horses

Organisations are different and scopes of activity are diverse


Organisations are different

Activity fit for purpose Resources differ -small one man operations to large

organisations Different approaches used by organisations to

demonstrate competence Level of monitoring influenced by performance Environment is different Type of work -large volume routine testing/inspection

vs. infrequent testing


What is not acceptable?

Different assessors imposing conflicting requirements

Assessors imposing requirements that are not justified


Routine mechanisms to promote consistent application of the requirements

Ongoing assessor training and feedback by AB Ongoing monitoring of assessors by AB Assessors are rotated between organisations AB staff participate in assessments Policy documents published by AB to harmonise

criteria


Other mechanisms to promote Consistency

Assessor workshops

Feedback from organisations on assessments

Laboratory networks


Accreditation Process Survey 2006

Findings

What is most important to our clients?

93% Staff attitude /helpfulness 88% Access to information 88% Openness and Transparency 86% Value for money/added 81% Speed of Service

Relationship with INAB

95% agree that achieving accreditation is a significant accomplishment

93% agree INAB provide a quality professional service

66% agree that INABs membership of the MLAs is important to their business

53% agree that INAB is a client focussed organisation

Personnel and Service Handling

89% INAB is easy to contact

84% Staff competent and well informed

84% Respond in timely manner

81% Friendly and Helpful staff

70% Accreditation Officers justify and take responsibility for decisions made

Enquiry and Application Stage 72% agree INAB provide a professional information

pack/brochure 89% agree that the Accreditation officer dealt with

initial queries adequately 71% agree that Application Form was clear and

unambiguous 89% agree that a good standard of service was

received 89% agree that Applications for accreditation are

processed in a timely manner. 76% agree that extensions to scope are processed

in timely manner

Visits - Planning

Respondents agreed that…

94% Purpose and nature of visit clearly explained

95% Visit arrangements handled efficiently and effectively

95% Assessment team prepared well for visit

87% Assessment team had skills and knowledge

92% Meetings scheduled and well timed

Visit - Conduct

Respondents agreed that… 66% - Assessment team resolved our concerns

on the day 97% -Assessment team assessed our

competence for a specific range of activities 90% - Assessment team communicated in a

controlled and professional manner 81% - Assessor understood our business 89% - Findings presented in a calm and factual

manner 92% - Assessor demonstrated current

competence in activity being assessed

Visit - Outcome

Decision on our accreditation promptly relayed (90%)

Registration number and certificate received promptly (79%)

INAB promotes our accreditation appropriately on the website, newsletter and press (57%)

Experience of Service over last 2 years

•Others applicants with under 2 years service

Assessing Competence

Marie O’Mahony

Assessing Competence

• Focus of Technical Assessment

• Quality Management Systems within technical activities

• Vertical Audits

• Scope Matrix and Visit Plans – Accreditation Cycle

• INAB Officer Key Roles

• Outcome

Focus of Technical Assessment

• Peer Review Process – independent 3rd party assessment- Verification of applicants/accredited organisation’s claim of technical competence

• Key focus is technical competence and compliance with INAB Regulations/Policies (EA/ILAC/IAF; e.g. Use of Accreditation Symbol)

• Assess Competence of Organisation for Scope of Accreditation

• -Documentation Review/Discussions/Witnessing/Records review/Vertical Audits


• Clarify Scope- Methods/Matrices/Ranges/ Level of Validation

- Personnel- Qualifications/Experience/Performance

- Facilities/Equipment/Sample handling- Space/environmental conditions- Performance qualification/calibration/maintenance- storage/Labelling/separation

- Analytical Quality Control- Internal Quality Control / External PT Schemes/ILCs

- Reporting the results


Quality Management Systems in technical activities?

- Roles/responsibilities

- Documentation control

- Contract Review with client – Records

- Critical consumables/services

- Non-conforming work / investigation reports/root cause analysis/CAPA

- Technical Records access/storage/audit trail

- Vertical audits

Vertical Audit

Why?

• Good indicator of level of implementation of Quality Management Systems and Technical Management systems

• Review quality of vertical audits done by organisation

• Perform vertical audit – snap-shot of systems from receipt to reported results

• Feedback to Lead Assessor

• Pre-assessment/surveillance/extension to scope

Scope Matrix and Visit PlansAccreditation Cycle

ISO 17011 “Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies”

• Clause 7.11.3 “The accreditation body shall design its plan for reassessment and surveillance of each accredited CAB so that representative samples of the scope of accreditation are assessed on a regular basis.”

• Clause7.11.1 “Re-assessment is similar to an initial assessment except that experience gained during previous assessments shall be taken into account. Surveillance on-site assessments are less comprehensive than re-assessments.”

Scope Matrix and Visit Plans

EA-3/09 “Surveillance and Reassessment of Accredited Organisations”

• (2.4) Surveillance assessment plan:- Plan made by the AB in which it schedules surveillance activities and visits, in particular based upon areas of competence, for a particular organisation between the initial assessment and reassessment”

• (3.6.2) “The AB should aim at assessing a representative sample of the accredited activities, covering all areas of competence, during the period between reassessments or between accreditation and the first re-assessment.”

Scope Matrix and Visit Plans

• 5 year Accreditation Cycle

• Scope Matrix – Record of scope elements covered in cycle

• Visit Plan – Record of each visit

• Review Visit Plan on annual basis against Scope and scope matrix to ensure all elements are covered in cycle.

• Highlight on AF118 specific areas to be assessed at the next visit.

INAB Officer Key Roles

• Manage relationship with applicant/accredited organisation

• Monitor ProcessHarmonisation of the process- Ensure fair/objective/thorough assessment activities

• Balanced Reporting – Categorisation

• Assist team – Management Systems

• Principal focus on Management Systems and INAB Regulations/Policies

• INAB Officer is not Technical Assessor/Expert

• Prepare recommendation for decision post-visit

Outcome

• Provision of a value-added service to the organisation

• Verification of Technical Competence for scope

• International recognition and acceptance of Accredited reports/certificates

• Independent 3rd Party Objective Assessment

• Confirmation of continued technical competence

INAB PoliciesPS10/PS10a / PS12

Adrienne Duff

PS10 - Laboratories and PS10 (a) – CBs and IBs• Submission of Documentation in preparation

of an INAB Visit

• Purpose• Effectively prepare for a visit• Efficient time management on site

PS10 Content - Laboratories

• Quality manual• Identified changes to test methods and QM• PT/ILC Summary• Audit Schedule• Minutes of mgt review• Medical lab information• Flexible scope information• In-house calibrated equipment


• Review of legislation (see PS12)• Audit of effectiveness of corrective actions

(AF118)• Insurance declaration

• Submitted by lab 4-6 weeks in advance of a visit

• Sent to lead assessor and others• Extensions to scope


• Information used to prepare visit plan and prepare for the visit

• Identify (potential) issues in advance

• Use with information provided from scope matrix and/or previous visit documentation (F116, AF118) to prepare visit plan

• Any member of assessment team can request documentation from lab via INAB officer

PS10a Content – CBs and IBs

• QM and documented procedures, identifying changes

• Minutes of mgt. review• Schedule of internal audits• Audit of effectiveness of corrective actions• Legislative review• Changes to structure, impartiality

committee, related bodies

PS10a Content – CBs and IBs

• New certificates issued• Insurance declaration

• Audit plan• Previous client report• Competency justification and records• Technical review

• Extensions to scope (PS16)

PS12

Policy for accredited organisations undertaking work in an area which is regulated by legislation

Organisations undertake work which may be required to be undertaken in an area regulated by legislation

Regulated• Directives (transposed into national legislation)• Statutory Instruments (SI)• Regulations

PS12

Policy• Obligations on accredited organisations to be

aware of customer legislative requirements• Review capability• Inform customer accurately and clearly of it’s

capability and how this relates to scope of accreditation

PS12

CAB has responsibility with Customer to:• Regulatory requirements• Limitations or otherwise of INAB scope• Extent to which CAB can meet the needs of the

customer• Reporting formats, if specified in legislation

CAB has responsibility with Regulator to:• Clarify issues regulated by the legislation• Utilise guidance, where available, or justify

alternative

PS12

INAB expects this to be assessed through the

Contract Review Process

Central to this is CAB’s understanding of the purpose for which customer requires work and understanding of their own capability

PS12

INAB Technical Assessment……..for Labs

• Appropriate contract review• Impact assessment• Assess and confirm that accredited

method meets requirements

PS12

INAB Technical Assessment……..for CBs and IBs

• Appropriate contract review• Impact assessment• Has organisation competence to meet

requirements?

PS12

• Adequate records to demonstrate contract objective review process

• QS which permits regular updates • Ext to scope

• Suitably validated (labs)• Technical review (CBs and IBs)

INAB scopes make reference to legislation in various ways• Blood Banks • CBs/IBs

PS10, PS10(a) and PS12

Questions and Feedback

Categorisation of non-compliances, corrective actions and timescales

Andrew Stratford

Non-compliances

• Feedback to the organisation• Add value• Factual observation, supported by

comments to explain• Clear and specific, using examples• Agreement from organisation on the factual

nature of the observation

Non-compliances

• Address system issues not just numerous isolated issues

• Quantity not important• Categorisation of non-compliances:

• Major• Minor ( both equivalent to UKAS ‘M’ Mandatory

Improvement Action)• Observation (equivalent to UKAS ‘R’

Recommended Improvement Action)

• Difference between INAB and UKAS…

Non-compliances

• A minor non-compliance is allocated for a minor failure to comply with INAB requirements

• E.g. not providing an up-to-date specification for one particular test or for not providing adequate operating instructions for the staff using a particular piece of equipment (Such incidents might be indicative of a more widespread lack of control, and they should prompt the assessor to probe more deeply).

(taken from INAB P7)

Non-compliances

• A major non-compliance is allocated when the quality arrangements are demonstrably inadequate, or totally absent for a major aspect of the CAB’s work. An example of this would be the complete absence throughout a laboratory, or in several parts of a laboratory, of a system for calibrating the laboratory’s testing and measuring equipment.

• A major non-compliance may also be allocated when a number of similar minor non-compliances have been raised and where this indicates a possible weakness in a particular area of the quality or technical systems.

(taken from INAB P7 – guide to INAB assessment procedures)

Non-compliances

• A minor non-compliance is the failure to comply with the scheme requirements.

• A major non-compliance is the failure to comply with the scheme requirements to the extent that could compromise the confidence that is placed in the accredited activity.

(Taken from INAB Regulations)

Non-compliances - consequencesConsequences of raising a major NC:

• May not recommend award of accreditation (if initial assessment)

• May recommend suspension of accreditation (if surveillance visit)

• If suspension or additional visit not recommended, justification for this must be entered on AF118 Summary Report.

Consequences of a major Non Compliance• In the event of a major non-compliance being raised, the

lead assessor in consultation with the INAB officer shall:• consider recommending suspension/termination/refusal of

accreditation for part or all of the scope of accreditation;• decide if an additional and/or unannounced visit is required

to witness the clearance of the non-compliance or to address any issues relating to its clearance;

• review the reports from previous surveillance/other visits to the organisation to ascertain if the history of the organisation, when taken together with the major non-compliance, indicates an underlying problem with the maintenance of accreditation;

• ensure that the integrity of INAB accreditation is not compromised by any action or timeframe agreed to address the major non-compliances.

Consequences of a major Non Compliance• In any case, INAB shall require corrective action

evidence to be submitted and to include:• Immediate correction of the issue giving rise to the

major non-compliance. This may involve notifying customers and/or withdrawing test results or certificates,

• Root cause analysis and investigation,• Corrective action and, where appropriate, preventive

action.

• The timeframe for receipt of this evidence shall not exceed 2 weeks from the date of the visit.• In exceptional circumstances, INAB may alter this

timeframe.

• AF 117 – Detail report• Section for corrective

action proposed by the organisation

• Section for identification of evidence to be supplied by the organisation.

Corrective Action(s) proposed by the organisation• Normally agreed at time of the assessment to ensure

that both INAB and customer understand reported issue

• May need time to analyse and establish root cause; action may be an outline proposal to address the finding rather than the specific corrective action itself

• In exceptional circumstances INAB will allow a 2 week period for proposed corrective actions. The proposed corrective actions must be accompanied with a root cause analysis and investigation of the non-compliance.

• If clarity is required, identification of what sort of evidence will be supplied by the organisation

Corrective Action Evidence

Responsibility is with the assessor to accept and to

• Ensure it will address the issue• Ensure it will address system issues not

just the isolated case

Timescales

• 1 month/3 months for organisations. • 15 days for assessors to complete F121 and

respond to each corrective action separately

• Responsibility is with assessor to ensure it addressed the issue

• Verification of effective implementation at next visit.

Timescales

Timescales

• INAB may in exceptional circumstances permit an extension to these timeframes where the organisation can establish that more time is justified. In such circumstances the extension to the timeframe will apply only to the clearance of the particular non-compliance(s) requiring the extension to the timeframe. All other non-compliances must be cleared within the normal timeframes

Timescales

• INAB may decide to set a new timeframe for the satisfactory clearance of outstanding non-compliance(s) and in such cases, shall inform the organisation in writing of the decision taken

• The new timeframe shall not exceed one month except where the organisation (or element of scope of accreditation) is suspended in which case a timeframe of up to 3 months will apply

• Where an organisation under suspension fails to clear all non-compliances within the agreed timeframe that organisation’s accreditation may be terminated.

Aspects of the Accreditation Process

Patrick O’Brien

Deviating Samples Patrick O’Brien

Handling of Deviating Samples

• Review what we understand to be a valid tests result• Accreditation and sampling - the practice • Typical samples of Deviating samples• Requirements of ISO / IEC 17025• INAB / EA Laboratory committee view• Conclusion

Handling of Deviating Samples by accredited

laboratories ISO / IEC 17025 & 15189

In order to obtain valid tests results, the quality of the following shall be ensured:-

• sampling, • sample pre-conservation and logistics, • analysis, • and reporting

Accredited laboratories ISO / IEC 17025 and ISO/IEC 15189

• Very few laboratories accredited for sampling – Ireland/Europe

• Majority receive samples at the laboratory reception or in some cases will collect them from clients premises or on-site.

• Accreditation Bodies have not focused on sampling, preservation, transportation, and reception of samples.

Deviating Testing Samples – Examples

• Exceeding maximum pre-conservation time• Date and time of Sampling not known• Not acidified (e.g. analysis of metals)• Filtered (analysis of wastewaters)• Not cured in controlled environmental conditions

- Not cooled (food)- Not cured in water while on site (concrete cubes)- Insufficient sample size, - Deviating from test methodsetc, etc, …..

Requirements of ISO / IEC 17025

• Clause 5.8.3 Recording of deviating samples upon receipt and subsequent consultation with the client.

• Clause 5.7.2 Deviation of a documented sampling procedure (e.g. pre-conservation) on request of the client shall be recorded and reported.

• Clause 5.10.1 Results of tests shall be reported accurately, clearly, unambiguously and objectively.

Deviating Samples – EA / INAB policy

EA / Laboratory committee have concluded that:- • Upon receipt of each sample, a competent laboratory

shall assess whether the sample is suitable with regard to the requested test(s);

• When the sample is deviating, an accredited laboratory shall contact the customer for further instructions;

• When the customer wants the deviating sample to be analysed, an accredited laboratory shall included a disclaimer in the report, clearly stating that the sample was deviating and that, as a result, the test result(s) may be invalid;

Conclusion

During assessment of laboratories the INAB team is again reminded to ensure that, they strengthen their focus on laboratories handling of deviating samples and the inclusion of disclaimers by them in the corresponding test reports.

EA peer evaluation of AB’s will be focusing on how assessment teams assess deviating sample.

Use of INAB Policies / INAB Regulations / Terms & Conditions during assessment

Patrick O’Brien

Use of INAB Policy statements, Regulations, and Terms and Conditions during assessment

WHERE TO FIND? • On the INAB Website, under publications, • See DC1 document

DC1 lists mandatory, policy, and guidance documents that are

relevant to the various INAB accreditation schemes

Includes current INAB documents:- • Policy Statements PS1 to PS16 (Mandatory)• INAB R1 Regulations (Mandatory)• Terms and Conditions (Mandatory)

Use of INAB Policy statements, Regulations, and Terms and Conditions during assessmentWe are now aware of their existence and where to find them !

What do we do with them:

• use together with the accreditation standards as part of the Inab assessment criteria in the assessment of CABs

• Who should be aware of them and uses them !

• All of the team, including the technical assessors and technical experts.


Examples when the INAB assessors may refer to clauses of INAB mandatory

documents:-

Clause 3.5 of INAB Regulations (R1) “Where an organisation wishes to make reference to its INAB accreditation rather than using the accreditation symbol”

Clause 3.6 of INAB Regulations (R1) “An organisation claims accredited in respect of the activities which are defined in the ‘scope of accreditation’.


Further Examples

Clause 3.15 of INAB Regulations (R1) “An organisation use of the accreditation symbol.”

Clause 3.23 of INAB Regulations (R1) “An INAB accredited organisation provide

certification to any standard used as a basis for accrediting Conformity Assessment Bodies (CABs)

(e.g. ISO 17025, ISO 15189)”

Use of INAB Policy statements, Regulations, and Terms and Conditions during assessmentFurther Examples

Clause 3.10 of Terms & Conditions “Requirement for an accredited organisation to inform INAB of any change affecting any matter affecting the Organisation’s ability to comply with the Accreditation Criteria or the Contract….”

Clause 3.11 of Terms & Conditions “The Organisation shall notify INAB in writing of any change of ownership or control of the Organisation or any sale by the Organisation of its business...”

Use of INAB Policy statements, Regulations, and Terms and Conditions during assessmentFurther Examples

Clause 3.11 of Terms & Conditions “The Organisation shall notify INAB in writing of any change of ownership or control of the Organisation or any sale by the Organisation of its business...”

Clause 6.1 of Terms & Conditions

“Without prejudice to the Organisation’s general legal obligations in relation to the maintenance of its records, the Organisation shall keep, for a minimum period of 5 years…..”

Use of INAB Policy statements, Regulations, and Terms and Conditions during assessmentFurther ExamplesINAB Policy PS 1: -proficiency testing / inter-laboratory

comparisons

“Accredited laboratories are required to participate and achieve satisfactory performance on an annual basis for each round in an appropriate proficiency testing scheme or inter-laboratory comparison where such schemes are available and relevant to their scope of accreditation.”

Etc, etc, ………………..

EA / IAF/ ILAC Guidance Documentation

Patrick O’Brien

EA Documentation

The application of EA documents have been Categorised

into four categories 1 to 4.

EA Documentation Categories of EA publications

1. EA MLA procedure documents2. EA MLA support documents3. EA MLA Sector specific documents4. EA - Technical documents

Category 1 EA MLA procedure documents

• EA MLA procedure documents lay down the requirements for the operation of the MLA

• EA-2/13 « EA Cross Frontier Policy for Cooperation between EA Members «

• Allows for an AB operating outside its jurisdiction to subcontract to that

countries AB to undertake some of these activities in future when EA 2/13 is implemented, it becomes effective on a staged basis starting in May 2008

Category 2. EA MLA support documents

EA MLA support documents are documents of a horizontal nature that support the application of the standards used for accreditation. (Mandatory) Examples:-

• EA- 4/02 - Expression of the Uncertainty of Measurement in Calibration. • EA- 4/16 - EA guidelines on the expression of uncertainty in quantitative

testing

These documents must be implemented by EA member accreditation bodies for use in their accreditation systems.

Their implementation are assessed as part of the EA MLA peer evaluation process.

Category 3.EA MLA Sector specific documents

EA Sector specific documents are sector specific and support the implementation of the standards used for accreditation in sector specific applications.

These documents must be implemented by EA member accreditation bodies that provide accreditation in the sectors in question for use in their accreditation systems.

Their implementation will be assessed as part of the EA MLA peer evaluation process.

4. EA / Technical documents

Technical documents are documents that provide technical or scientific guidance that defines recommended examples how to fulfil the criteria. (Example….)

EA-4/09 « Accreditation for Sensory Testing Laboratories »

Also:- Under an EA/Euromet MoU, Specific Calibration documents transfered to Euromet who accepted to manage them in future.

IAF (International Accreditation Forum)

Guidance Documentation (GD series)- IAF Guidance documents are not intended to establish, interpret, subtract from or add to the requirements of any ISO/IEC Guidance but simply to ensure consistency application of those Guides

IAF (International Accreditation Forum)

Example:- IAF – GD 5 : 2006 “Guidance on Guide 65:1996” (Product Certification) All IAF Members are required to comply with the IAF guidance on the application of ISO/IEC Guide 65:1996 (Mandatory)

IAF – GD 8:2007 “Information Guidance on the Transition to ISO/IEC 17021 Accreditation from Guide 62 and Guide 66

IAF/ILAC A4 “Guidance on the application of ISO/IEC 17020 (Mandatory)

ILAC Documents (International Laboratory Accreditation Forum)

Examples:-

• ILAC G9:2005 Guidance for the Selection and Use of Reference Materials

• ILAC G13:08/2007 Guidelines for the Requirements for the Competence of Providers of Proficiency Testing Schemes

• ILAC G22:2004 Use of Proficiency Testing as a Tool for Accreditation in Testing

• ILAC G24:2004 Guidelines for the determination of calibration intervals of measurement instruments

Conclusion use of EA/ILAC/IAF documentation

INAB assessors, including technical assessors, are reminded that they need to be fully aware of current EA / ILAC /IAF documentation and ensure that you assess CAB’s accordingly to such documentation as appropriate.

In-house Calibrations PS 13 &

Sampling

by Patrick O’Brien INAB Assessor Forum -January 2008.

INAB Policy on the Performance of In-house Calibrations P.S. 13

It recognises that organisations accredited for calibration, testing or inspection activities may choose to carry out some calibration activities in-house to support their measurement activities rather than seek the services of an external accredited laboratory.

When an in-house calibration is carried out the calibrated equipment remains “fit for purpose”PS13

INAB Policy on the Performance of In-house Calibrations PS13

The INAB team should ensure that where an organisation is accredited for calibration, testing or inspection activities and carries out in-house calibration these calibrations are

- Carried out in an appropriate environment - by trained personnel - Using documented calibration procedure, - traceability of measurement is maintained- that uncertainty of measurement budget and procedure for

calculating same is in place.

INAB Policy on the Performance of In-house Calibrations PS13

It is expected that wherever possible the assessment of in-house calibrations will be covered as part of the traceability and calibration aspects within normal assessment/surveillance activities.

INAB Policy on the Performance of in-house Calibrations PS13

• Specialist calibration assessors will be used if the in-house calibration is outside the area of expertise of the assessment team.

• The assessment procedures will include document review and on-site witnessing as appropriate.

• On-site witnessing of in-house calibration activities can be expected at least at initial assessment and reassessment visits

• An organisation may be required to participate in measurement audits for the in-house calibration activities

Accreditation of Sampling activities

INAB’s policy on sampling activities

• Accredit only if sampling activity is carried out in accordance with standard methods.

Flexible Scopes of Accreditation

Sinead Guckian

Outline

• Scope of Accreditation• Flexibility categories• Requirements• Application Procedure• Assessment• Presentation of a Flexible scope• Constraints

Accreditation

Accreditation is the formal recognition of a body’s competence to conduct a specific activity such as testing/ calibration, inspection or certification

Scope of Accreditation

• Scope of accreditation• Establish accurately

and unambiguously the range of activities

• Accurate description • Guarantees an

appropriate evaluation of competence

• Fixed scopes of accreditation

Fixed Scopes

• Listing specific activities v’s defining its competence

• New or modified tests added to a labs scope • Competence in this general area has already

been demonstrated. • Timescales involved in applying for

Extensions

“Flexible Scope”

• Tests may not initially be explicitly stated on their INAB scope of accreditation

• Competence in the development and validation of tests has been evaluated

• List of Additionally Accredited Tests (LAAT)• Claim accreditation without prior approval

from INAB• Added post surveillance visit

“Flexible Scope”

• EA-2/05: “The Scope of Accreditation and Consideration of Methods and Criteria for the Assessment of the Scope in Testing”, EA, European co-operation for Accreditation, August 2001.

• ILAC-G18: 2002: “The Scope of Accreditation and Consideration of Methods and Criteria for the Assessment of the Scope in Testing”, ILAC, International Laboratory Accreditation Cooperation

• The European Co operation Laboratory Committee

Terminology

• Flexible in their entirety• Combination of fixed and flexible methods, • Primarily fixed scopes that include one or

two flexible methods

Flexibility Categories

• Flexibility for materials/products tested i.e P9 category, matrix

• Flexibility concerning test parameters - analytical parameter, accredited range

• Flexibility concerning the performance of the method - sample preparation, clean-up procedure

Requirements

• Laboratory will be required to demonstrate• Fixed scope is too restrictive • An extended management system

capable of controlling the flexible scope • The technical competence and

experience – first reassessment

Requirements

• Management System• Authorise technically competent individuals

• the development and revision of the testing methods

• validation of methods• authorisation to approve implementation of

new methods• Establish a validation Strategy

• criteria for the acceptance of validation results• confirm that the method is suitable for the

intended purpose• inform the client of the results of the

validation.

Requirements

• One individual with responsibility for each validation job• Can assess suitability of a method –

customer needs• Can draw up a specific validation plan• Can assess the performance of the

method• Results from validation shall be documented

in a report

Requirements

• Maintain record of any changes

• Procedure for processing requests, tenders and contracts• Implications• Possibility unable to issue accredited test results

• Protocol for applications for test under flexible scope• Reference material, Equipment• Suitably qualified personnel• Responsibilities are assigned• Necessary validation activities are carried out• Implementation of new tests is authorised

Requirements

• If validation procedure inability to issue accredited test reports – corrective action• Informing it client • Revision of the relevant procedures or

method • Maintaining a record of the occurrence

• Internal audit & Management reviews

Application

• Fulfilling the requirements• Extensive experience in performance of

specific tests• Adequate experience in development and

validation of testing methods• Acceptable results in internal and external

quality assurance, INAB assessments• Measurement equipment to operate within

the full testing category

Application

• Preliminary Evaluation Process• Experience in testing category –

development and validation • Experience in the specific tests - Annual

number of analysed samples• Internal & external Quality assurance • Justification of the requirements for a

flexible scope

Application

• Extension to scope application form• Protocol for dealing with request for tests• Validation protocol• Proposed test procedures• List of Key personnel authorised

• 3 months

Assessment visit

• The implementation of the Management System

• The competence of the individuals• Specific examples of the tests for which

the laboratory has applied a flexible scope

• Reporting• Means of informing clients

Presentation

• Similar fashion to that used for fixed scopes

• List of Additionally Accredited Tests• Controlled by the

laboratory• Publicly available

Presentation

• List of Additionally Accredited Tests• Laboratory Reg. No.• Current edition of the

INAB schedule • Matrices and P9

classification that apply to the flexible scope of accreditation

• The group of tests and the list of additional tests within each group

• The date on which each test was added

• Measurement range and/or limits of detection

Maintenance

• Implementation and effectiveness of controls• Technical competence and use of the

established management system• PS10

• LAAT• Full validation reports• Summary of changes

• Added to the laboratories scope of accreditation

Constraints

• A reflection of the competence of the Lab• Generalised issue of reports outside

accreditation within a category may question accreditation for flexible scope.

• Not enable a Lab to move into a new field of accreditation – cannot jump P9 Category

• Chemical Testing Laboratories

Thank you

Quoting Measurement Ranges And Detection Limits

On Microbiological Scopes

FRANK CROWE

Measurement Ranges And Detection Limits

•Methods must be validated for specific measurement ranges.

INAB Policy

•Detection limits must be calculated where appropriate.

•Regular demonstration of laboratory capability to achieve detection limits and measurement ranges.

•Detection limits and measurement ranges are clearly discussed with customers at contract review.


The Rationale for not quoting Detection Limits

•To quote LOD’s on the scope can be misleading, as the implication is that the quoted LOD will apply to each test.

•There is no certainty that the target organism even if it is there, will be detected.

•To state a detection limit gives a strong message that "if it's there, we'll find it!“.

•Its more a case of we may find it, but there are no guarantees.

Microbiology unlike Chemistry does not haveclear certainties associated with detection limits.


Assumptions Even if the detection limit is not quoted on the scope, laboratories must undertake

practical work to show that their methods perform at levels close to the theoretical limits.

LOD’s should be estimated as part of method validation where required.

•Not adhering to the requirements of ISO/IEC 17025 – 5.4.5.3, EA-04/10. •Cannot carry out Contract Review.

•Establish customer requirements.

Otherwise

Measurement Ranges And Detection LimitsRequirements of the Assessment Team

Assessors must satisfy themselves that laboratories areactively calculating detection limits for each test where required.

•Contract Review.

•Validation Records.

•Analytical Quality Control.

•Uncertainty of Measurement.


Summary

•It is important that laboratories calculate detection limits as part of their method validation.

•Laboratories must discuss detection limits with customers.

•Assessors must be satisfied that laboratories can demonstrate their ability to achieve detection limits.

•Laboratories must ensure detection limits are appropriate for customer’s requirements.

•Assessors must be satisfied that laboratories can continue to demonstrate their ability to achieve these detection limits.


Discussion & Questions

Professional Fees and Expenses

INAB Assessor Forum -

January 2008

Emma Scott McGrane

Assessor Claim Form – IR04 F1

• Assessor Claim Form must be accessed via Extranet.

• Complete “Assessor Claim Form for Professional Fees and Expenses – IRO4 F1”.

• Return Forms to Forfas Accounts, Forfas, Wilton Park House, Wilton place, Dublin 2.

Accessing the INAB Extranet

•All Users have a Password & Username

•Log on to the website – https://www.lgp.ie/inab

https://www.lgp.ie/inab

https://www.lgp.ie/inab

Accessing the INAB Extranet

Assessor Claim Form – IRO4 F1

Part A: Professional Fees (As per Schedule 3 of

Assessor contract).

Part B: Assessor Expenses (As per Schedule 4 of Assessor

Contract).

Compliance

Assessor Claim Form must comply with Schedule 4 of the Assessor Contract.

All corresponding receipts and actual airline tickets must be submitted.

Evidence of Exchange Rate must be documented.

Compliance

Assessor Claim Form must comply with Schedule 4 of the Assessor Contract.

A Current Tax Clearance Certificate is required.

A Purchase Order Number must be quoted on form.

A Separate Assessor Claim Form must be completed for every job invoiced.

Invoice Processing

INAB Officer

INAB Manager

Forfas Accounts

•C

•A

•B

Invoice

Professional Services Withholding Tax (PSWT)

- Applies to Payments made by Public Bodies in respect of all persons who provide Professional Services.

- All professional services are subject to PSWT.- PSWT is deducted at the Standard Rate of

Income Tax from the total amount of the payment.

- It is not an additional Tax.


- A Public Body is obliged to deduct the PSWT from the total amount of the payment due:

-Including any amount in respect of expenses

-Excluding any VAT charged by the taxpayer etc.


Payments to Non Residents

- PSWT must be deducted from all relevant payments to non-residents.

- Where PSWT is deducted from a payment to a non-resident, a F45 form must be issued in respect of that payment.

- Amount on forms is always in Euro.


Where a non-resident is NOT chargeable to tax in the state:

Repayment claimed from: The Revenue Commissioners, International Claims Section, Collector General, Government Offices, Nenagh, Co. Tipperary.E-Mail: [email protected]

mailto:[email protected]


Where a non-resident IS chargeable to tax in the state:

- Claims for credit, refund, or interim refunds of PSWT are made to:

The Revenue District to whom they make their tax returns.E-Mail: [email protected]

mailto:[email protected]

Tax Clearance Certificate

-Written confirmation from Revenue that Tax Affairs are in order at the date of issue of Cert.

- A current TCC is required as a condition of obtaining a Public Sector Contract.

Tax Clearance Certificates

• Applicants can download application form TC1 at:http://www.revenue.ie/forms/webtc1.pdf

Completed forms to be forwarded to the appropriate address having regard to the category type of applicant (resident / non resident).

• Appropriate addresses can be accessed at:http://www.revenue.ie/index.htm?/services/bus_guides7.htm

http://www.revenue.ie/forms/webtc1.pdf

http://www.revenue.ie/index.htm?/services/bus_guides7.htm

http://www.revenue.ie/index.htm?/services/bus_guides7.htm

Thank you

WELCOME INAB ASSESSOR FORUM 22 nd and 29th January 2008.

Documents

Transcript of WELCOME INAB ASSESSOR FORUM 22 nd and 29th January 2008.