Annex 1 - gov.uk › government › ... · Web viewAnnex 1 AUDIT CHECKLIST (Essential elements to...

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Annex 1 AUDIT CHECKLIST (Essential elements to be included within the audit) 1) Designation letter (review conditions) Designated name Local Authority/group of Local Authorities Personnel operating under designation Scope of designation Review scope and class of instruments Conformity assessment tasks Types of instrument / sub categories of instrument 2) Essential Requirements Sub-contracting arrangements Testing by others Calibration by others Core criteria in the directives (annex V NAWI article 12 MID) Met at time of application Met on a continuing basis Independence and Insurance 3) Quality system Manual Procedures Plans Where a Notified Body is formed of a group of Local Authorities, are they operating to a common quality system? 4) Standards Local standards, working standards, test weights, EEC Directive weights Calibration, EEC verification of weights and other standards Standards maintained in-house, hired-in, other arrangements Range of standards available 5) Verification TAC and TC where appropriate Assessment of conformity to type Declaration of Conformity Certificate of 1st stage verification (if applicable) Verification tests Recording of the results (It is especially important that test sheets are correctly completed).

Transcript of Annex 1 - gov.uk › government › ... · Web viewAnnex 1 AUDIT CHECKLIST (Essential elements to...

Page 1: Annex 1 - gov.uk › government › ... · Web viewAnnex 1 AUDIT CHECKLIST (Essential elements to be included within the audit) 1)Designation letter (review conditions) Designated

Annex 1

AUDIT CHECKLIST (Essential elements to be included within the audit)

1) Designation letter (review conditions) Designated name

Local Authority/group of Local AuthoritiesPersonnel operating under designation

Scope of designationReview scope and class of instrumentsConformity assessment tasksTypes of instrument / sub categories of instrument

2) Essential Requirements Sub-contracting arrangements

Testing by othersCalibration by others

Core criteria in the directives (annex V NAWI article 12 MID)Met at time of applicationMet on a continuing basis

Independence and Insurance

3) Quality systemManualProceduresPlansWhere a Notified Body is formed of a group of Local Authorities, are they operating to a common quality system?

4) StandardsLocal standards, working standards, test weights, EEC Directive weights Calibration, EEC verification of weights and other standardsStandards maintained in-house, hired-in, other arrangementsRange of standards available

5) VerificationTAC and TC where appropriateAssessment of conformity to typeDeclaration of ConformityCertificate of 1st stage verification (if applicable)Verification tests Recording of the results (It is especially important that test sheets are correctly completed).

6) Application of the marks Manufacturer i.e. CE marking and Green Metrology StickerApproved Body i.e. Notified Body Number Certificate of Conformity

7) Competence Evidence of staff training and knowledgeAssessment of competence to undertake EC verification

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Annex 2

Audit ReportCover sheet (only one cover sheet is needed per audit)LA Notified Body audited

Audit Officer LA Notified Body No.

Telephone No. of auditor Date audited

Supporting Audit Report e.g. ISO 9000 or UKAS (See auditing Protocol 3.3)TitleNumberAuditor’s signature/datePrint name …………………………….. Signature of auditorDate ……………………………………. ………………………………………………

Signature of Authority representative

Print name …………………………….. Signature of representative

Date ……………………………………. ………………………………………………

Agreed to carry out corrective action:Print name ……………………………… Signature of responsible officer (LANB)Job title ………………………………… ……………………………………………..

Auditor Satisfied corrective actions have been signed off and supplied with evidence corrective actions have been completed.

Print name …………………………….. Signature of auditor

Date ……………………………………. ………………………………………………

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Detail of activities Please use the audit checklist when conducting the audit ensuring all points are coverede.g. quality manual, procedures, plans or other documents

Item reference Notes NC’s

1) Designation Letter

Designated name

Scope of designation

2) Essential Requirements

Sub-contracting arrangements

Core criteria in the Directives being met

Independence and Insurance

3) Quality System

Manual

Procedures

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Item reference Notes N/C’s

Plan

Groups ofLANB all operate from same QS

4) Standards

Local & Working Standards, test weights, EEC directive weights

CalibrationMaintenance of Standards

Standards maintained in house, hired in other arrangement

Range of standards available

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Item reference Notes N/C’s

5) VerificationTAC & TC

Assessment of Conformity to Type

Declaration of Conformity

Certificate of 1st stage verification

Verification tests

Recording of results

6) Application of Marks

Manufacturer i.e. CE marking Green M sticker

Approved body Number

Certificate of Conformity

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Item reference Notes N/C’s

7) Competence

Evidence of staff training and knowledge

Assessment of competence undertaken

Witness verification

Opportunities for Improvement

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Details of non-conformities

page of

Item Reference

from activity sheet

Level of non-

conformityDescription of non-conformity Proposed corrective action

Date corrective action

completed

Auditor Signature

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Annex 3

EXAMPLES OF MAJOR/MINOR NON-CONFORMITIES

From paragraph 3.7 of the Auditing Protocol

Area/Activity audited Description of non-conformity Major/Minor non-conformity

EC Verifications Equipment has not been correctly verified MajorTest result sheet not correctly completed Major Incorrect markings placed onto instrument Major

Appeals No procedure to cover Appeals in relation to verification activities Minor

Procedure exists but not addressed within QS for EC verification of NAWI/MID Minor

Procedure exists however where refused submitter not made aware of right to appeal Minor

Certificates of Conformity (C of C)

No requirement within the procedure for the issue of C of C Major

In procedure but no C of C’s have been issued against any of the EC verifications carried out

Major

Individual case of C of C not issued Major

Training Records No training record in place for a member of staff performing EC verifications Major

Training activity non-existent on all training files Major

Training activity for member of staff not included on training record Minor

Competence Staff unable to competently demonstrate verification testing Major

Internal Audits No procedure or audit programme in place Major

Procedure/programme in place, no audits conducted Major

Organisation Structure Not identified clearly Major

Structure out of date or not accurate Major

Joint Arrangements Individual Local Authorities within the group not working to a common QS Major

Opportunities for Improvement

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The aim of this is to allow the auditor scope to offer the authority, group suggestions for areas that might be improved upon. These will not go against the overall assessment, however allows the auditor to point out those areas that perhaps are not so serious to be awarded a major or minor nonconformity but are noteworthy to the auditing process.