NON-CONFORMITY PAINS!

Transcription

1 Newsletter of the South African National Accreditation System Issue 8, October/November 2014 NON-CONFORMITY PAINS! by Dees Dhanraj Your conformity assessment body (CAB) was assessed and you have spent your valuable time in completing and submitting your corrective action in the prescribed period. You thought that you had addressed all the requirements; however, the feedback you just received from SANAS is that all the corrective actions have not been accepted. Your frustration grows and you ask yourself the following: what else does the assessor needs now ; or I do not want this assessor at the next assessment as he / she is too demanding. Now you have to spend your resources to address the Non- Conformance (NC) all over again. The resubmission of corrective actions impacts on your CAB s time, energy and other resources. A resubmission also has an impact on the assessor who has to review your submission. This article aims to help you to address some of the challenges and assist you in improving your submission of corrective actions and take away some of the pain and frustration when submitting them. This article also aims to remind you about the purpose of clearing nonconformances. Why clear non-conformances A CAB has a duty to implement corrective action to address non-conformance that was found during a SANAS assessment. The purpose is to give continued confidence to the user of a CAB services that the CAB can provide reliable results at all times and are able to address challenges when these occur. Who is responsible to clear non-conformances? It is everyone in the CAB s responsibility to address nonconformances. The clearing of non-conformances can be delegated to someone competent in the organisation, but ultimately it is still management s responsibility to oversee the clearance of the non-conformances. It is often heard that the process to clear non-conformance takes a lot of commitment of senior management in respect of time, money and effort to monitor, control and improve performance. Is this not part of the management function? How often we, as assessors, hear that the purpose of clearance of the non-conformances is to get SANAS off their back or that they do not get suspended, instead of integrating them into current business practice? Do you, as a manager, want to deal with the same situation time and time again? Is it not more valuable for you and your team to address the issues once properly? When non-conformances are addressed correctly, management will save time, money and effort. Tips for preparing your corrective actions During assessments During the assessment the CAB personnel are encouraged to ensure sufficient details be noted with regards to the findings and clarification should be sought from the SANAS assessors. The CAB personnel should also ensure that the facility representatives understand the non-conformance before the SANAS assessors leaves. Where required, the SANAS assessor can be asked to reword the findings so that the personnel can understand the deviation. It is important to note that by acknowledging the non-conformances the delegated person also takes ownership of the understanding of the finding. Training of personnel responsible for clearing of non-conformances For the optimum resolution of the non-conformance and implementation of the corrective action, it is imperative that the responsible staff member needs to understand the policy / procedure so do so. Thus adequate time should be allocated to training on both the corrective action procedure and implementation thereof. Submitting corrective actions When submitting corrective actions your facility should include the following evidence: 1) A thorough root cause analysis has been done to address the non-conformances having used your ed procedures. 2) Depending on the above root cause analysis that your CAB has reviewed the impact on its policy / procedure. 3) The necessary training has been provided to the relevant personnel. 4) The non-conformances was addressed by halting the deviation. 5) Corrective action was implemented. 6) Where necessary, your CAB has reviewed the impact of the non-conformances in respect of other work 1

2 NON-CONFORMITY PAINS! CONTINUE performed, normally through an internal audit and by correcting deviations where found. 7) All the necessary measures are in place to prevent re-occurrence of the non-conformances. 8) The CAB is able to demonstrate that the effectiveness of the corrective action has been assessed. References Definition of nonconformities by The Free Dictionary, viewed 8 July 2014, from com/nonconformities/ Hammar, M., December 30, 2013, Five Main steps in ISO 9001 internal audit, viewed 8 July 2014, from internal-audit/ ISO 9000, viewed 8 July 2014, from org/wiki/iso-9000[9 Jan 2014] ISO/IEC 17011:2004. Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies ISO/IEC 17011:2004, (corrected version; 15 February 2004) Kosutic, D, June 02, ISO Certification - Major vs minor nonconformities in the certification audit, viewed 8 July from com/2014/06/02/major-vs-minor-nonconformities-in the certification audit/ Praxoim Research Group Limited, ISO 9000, 2005: Plain English Definitions, viewed 8 July 2014, from praxoim.com/iso-definition.htm SANAS P04, Accreditation of laboratories and proficiency testing scheme providers, viewed 8 July 2014 from Sithole, M, Corrective action and Preventative action viewed 8 July 2014 from SADCAS/SANAS JOINT COMMUNIQUÉ - SADCAS ACCREDITATION SERVICES The Southern African Development Community Accreditation Services (SADCAS) is a multi-economy accreditation body established in terms of Article 17 (3) (b) of the Technical Barriers to Trade (TBT) Annex to the SADC Protocol on Trade with the primary purpose of ensuring that conformity assessment service providers operating in those SADC Member States which do not have their own national accreditation bodies are subject to an oversight by an authoritative body. Within the Southern Development Community (SADC) region, only South Africa and Mauritius have their own national accreditation body. The remaining 13 countries namely: Angola; Botswana; Democratic Republic of Congo (DRC) ; Lesotho; Madagascar; Malawi; Mozambique; Namibia; Seychelles; Swaziland; Tanzania; Zambia; and Zimbabwe do not have national accreditation bodies hence serviced by SADCAS. SADCAS is recognised by the SADC Council of Ministers as a subsidiarity organisation of SADC. The relationship between SADCAS and SADC is formalised through a Memorandum of Understanding (MOU) on general cooperation which also serves as the basis for the recognition of SADCAS, by SADC Member States as a multi economy accreditation body. SADCAS is now in its sixth year of operation as a multi economy accreditation body. Having been incorporated in December 2005, the SADCAS office was set up by the October 2008, launched in April 2009 and started to offer accreditation services in October Up to date SADCAS has issued 35 accreditation certificates to 26 accredited facilities in 6 SADC Member States. SADCAS accreditation services were kick started though a Twinning Partnership Arrangement with the South African National Accreditation System (SANAS). The Twinning Partnership Arrangement is meant to ensure the credibility of SADCAS accreditation services whilst at the same time benefiting from skills transfer from SANAS as SADCAS works towards signatory status in international accreditation arrangements. In working towards signatory status in the International Laboratory Accreditation Cooperation () as well as the African Accreditation Cooperation (AFRAC) Mutual Recognition Arrangements (MRA) for the accreditation of testing and calibration laboratories, the SADCAS application for peer evaluation was reviewed and accepted by the Arrangement Management Committee (AMC) and AFRAC MRA Committee. SADCAS subsequently underwent a joint /AFRAC pre peer evaluation from June The purpose of the joint pre peer evaluation was to: Provide SADCAS an opportunity to submit its accreditation system for an evaluation process that applies the same requirement and competences used in a peer evaluation for the AFRAC MRA and MRA; and Provide SADCAS an opportunity to identify findings in its accreditation system through an independent peer evaluation process. Whilst the evaluation team confirmed that the overall system of SADCAS is in accordance with the requirements of AFRAC M and -P5:10/2013, that SADCAS operates its testing laboratory and calibration laboratory accreditation programmes substantially in accordance with the requirement of ISO/IEC 17011:2004 and IAF/ A5:11/2013 and that laboratories accredited by SADCAS have been assessed against and found to comply with the requirements of ISO/IEC 17025: 2005, a finding was raised on the Joint Communiqe on SADCAS Readiness to offer Accreditation Services signed by SADCAS and 2

3 SANAS and issued on 12 April The Communique includes the following statement: 3. Through the SADCAS/ SANAS Twinning Partnership Arrangement, the accredited facility will be able to maintain international recognition. The facilities accredited under SADCAS/SANAS TPA are currently only listed in SADCAS directory of accredited facilities available on the SADCAS website and not in SANAS directory of accredited facilities. This, as the pre peer evaluation team noted, may mislead the international recognition of SADCAS. To address this finding, all facilities accredited under the SADCAS/SANAS TPA will now be issued with separate SADCAS and SANAS accreditation certificates and will be listed on both the SADCAS and the SANAS directories of accredited facilities available on the respective accreditation body s website. All certificates issued under the SADCAS/ SANAS TPA will contain a note to that affect. SADCAS is well on its way to signatory status in the MRA for the testing and calibration laboratories accreditation programs and aims to achieve the said status in the 2015/16 financial year after which only SADCAS certificate will be issued. SADCAS certificate will be issued. SADCAS is also working towards signatory status for its medical laboratories, inspection bodies and management systems certification bodies accreditation programmes. Maureen P Mutasa (Mrs) SADCAS Chief Executive Officer Ron Josias (Mr) SANAS Chief Executive Officer NEWLY PUBLISHED / REVISED SANAS DOCUMENTS Please take note of the list of newly published and revised SANAS s. These s are available on the SANAS Website. Doc No. Applicable Title Date published Comments P All facilities Management of extraordinary events or circumstances and conditions for terminating assessments New F Inspection Bodies Generic Checklist for Accreditation of Gas Container Test Station Inspection Bodies to ISO/IEC 17020: 2012 incorporating SANAS TR 86: Technical Requirements for the Application of ISO/IEC 17020, SANS and SANS 1825 F P P P Verification Verification Calibration laboratories, Testing, Medical laboratories, proficiency testing scheme providers SANAS Assessors and technical experts Assessment Cycle Matrix SANS Verification Accreditation of Verification Accreditation of laboratories and Proficiency testing schemes The SANAS Technical Assessor and Expert Information and Guidance Handbook Revised Revised Revised Refer to the Revised Refer to the Revised Refer to the P Inspection Bodies Accreditation of Inspection Bodies Revised Refer to the F SANAS Assessors and technical experts Datre of Issue: Approval of Assessor / Expert / AAC member / STC member including Areas of Expertise Revised F SANAS Lead Assessors Monitoring of Lead Assessors Revised F Certification Transition to ISO/IEC TS Competence requirements for auditing and certification of environmental management systems 3

4 F Certification Transition to ISO/IEC TS Competence requirements for auditing and certification of quality management systems F Certification Assessment Plan ISO/IEC 17021:2011 F Inspection Generic Checklist for Accreditation of Lift, Escalator and Passenger Conveyor Inspection Bodies to ISO/ IEC 17020: 2012 incorporating SANAS TR 85: Technical Requirements for the Application of ISO/IEC TR Inspection Department of Health (DoH) and SANAS Technical Requirements for the application of SANS/ISO/ IEC 17020: 2012 for testing of Diagnostic X-Ray Imaging Systems by Inspection Bodies TR Inspection Department of Labour (DoL) and SANAS Technical Requirements for the application of SANS/ISO/ IEC 17020: 2012 in the Regulatory Assessment of Lift, Escalator and Passenger Conveyor Inspection Bodies F General Confidentiality and Non-disclosure Agreement TR Calibration Criteria for Laboratory Accreditation in the Field of Radiation Dosimetry for Radiation Monitoring Equipment Revised Revised Refer to the Revised Refer to the Revised Revised Refer to the F Verification Audit Checklist: SANS : Revised TR Cal Criteria for Laboratory Accreditation in the Field of Pressure and Vacuum Metrology TR Cal Criteria for Laboratory Accreditation in the Field of Time and Frequency Metrology F Certification Specific requirements - Certification scheme for Food Safety Systems in compliance with FSSC F Certification Assessment Plan - ISO/IEC 17065:2012 F Certification ISO/IEC 17065: Vertical Assessment for PEFC 2002:2013 files F Certification Assessment Cycle Matrix for ISO/IEC 17065:2012 F Certification Checklist for ISO/IEC 17065: Requirements for bodies certifying products, processes and services F Certification Checklist for ISO/IEC 17024: general requirements for bodies operating certification of Persons F Knowledge Transfer SANAS Courses - Individual Registration Revised Refer to the Revised Refer to the Revised from 2003 version of the standard F Knowledge Transfer SANAS Courses - Group Registration F Knowledge Transfer SANAS In-house Training Courses - Customer and Delegate Detail Form TPAJ01-04 General Guidelines for SADCAS/SANAS Joint Assessments under the Twinning Partnership Arrangement P General The Responsibilities and Duties of the SANAS Specialist Technical Committees Revised Refer to the Revised Refer to the 4

5 THE FOLLOWING DOCUMENTS HAVE BEEN MADE OBSOLETE Please ensure that you delete / destroy any copies you may have: Doc No. Applicable Title Date published Comments F 172 Certification Transition from ISO/IEC 17021:2006 to ISO/ IEC 17021:2011. Assessment of Certification Body management of Competence 21/07/2014 Replaced by F211 and F212 NEWLY PUBLISHED / REVISED AND IAF DOCUMENTS The following listed s were published by and IAF, these are available on the relevant websites. Please access the relevant websites for these s: Website: IAF Website: Doc No. G19:08/2014 P9:06/2014 P15:06/2014 Applicable Forensic laboratories Calibration, Testing & Medical Inspection Bodies Title Date published Comments Module in a Forensic Science Process policy for the participation in proficiency testing activities Application of ISO/IEC 17020:2012 for the accreditation of Inspection Bodies Aug 2014 June 2014 June 2014 Provides guidance for forensic science units involved in examination and testing in the forensic science process by providing application of ISO/IEC and ISO/IEC This sets out the policy for accreditation bodies on the use of proficiency testing activities in the accreditation process This provides information for use by both accreditation bodies and inspection bodies on the application of ISO/IEC IAF ID8:2014 Certification IAF Informative for the transition of food safety management system accreditation to ISO/TS 22003:2007 IAF MD6:2014 Certification IAF Mandatory Document for the Application of ISO 14065:2013 Aug 2014 Note: This has replaced IAF/ A4:2004 Guidance on the application of ISO/IEC Informative to facilitate transition of ISO/TS 22003:2007 to ISO/TS 22003:2013. March 2014 Application from 23 March 2015 IAF MD 12: 2013 Certification Assessment of Certification Activities for Cross-Frontier Accreditation Sept 2013 Application from 04 September 2014 CONTACT INFORMATION SANAS website: Main Switchboard No: +27 (0) General Fax No: +27 (0) Physical Addresses: the dti Campus, Block G, Ground Floor 77 Meintjies Street, Sunnyside, Pretoria SANAS Knowledge Transfer Centre: 121 Muckleneuck Street Nieuw Muckleneuk Pretoria 0002 Private Bag X23 Sunnyside Pretoria