The Role of SANAS in Support South African Government Objectives Shadrack Phophi South African National Accreditation System 1

PRESENTATION LAYOUT Background to SANAS Relationship between SANAS & Regulators Benefits for regulators 2

SANAS The South African National Accreditation System SANAS is currently the one of the largest, internationally recognized, national accreditation body in the world. It was inaugurated in 1996 (as a section 21 company) The Accreditation Act, Act 19 of 2006, was passed and SANAS became a public entity (agency of the dti) on 16 March 2007 (Full Title: The Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act) Accreditation is increasingly being used by SA Regulators, as part of managing local regulatory risk, to ensure both the competence and consistency of outcomes of service providers used in the local regulatory domain 3

SANAS SANAS is recognized as the only national body responsible for carrying out accreditation in respect of conformity assessment, which includes: Calibration, Testing and Verification Laboratories Certification Bodies Inspection Bodies Rating Agencies and Monitoring of GLP compliance with OECD principles 4

SA TECHNICAL INFRASTRUCTURE Government Acts & Regulations NRCS; DoL, DEAT, DME, DoH etc. SABS Standard Div. SANAS Accreditation Standards/Specifications Technical Infrastructure Traceability Conformity Inspections NMISA NRCS

SA TECHNICAL INFRASTRUCTURE 6

Roles of Government Bodies and Regulators Protecting the health and welfare of consumers and the public. Protecting the environment Developing new regulations and requirements Measuring compliance with regulatory and legal requirements Allocating resources, both technical and financial 7

Roles of Government Bodies and Regulators In order to make informed decisions, they must have confidence in the data generated by laboratories carrying out testing, measurement or calibration in these fields Using an accredited laboratory can help establish and assure this confidence 8

Government using Accreditation Many countries now rely on Accreditation as a means of determining technical competence. Accreditation has become “mandatory” in many regulated areas as more and more regulators appreciate the benefits that accreditation brings in assisting governments to meet their obligations and responsibilities to safeguard the public and the environment 9

Cont… Minister Davies in 2006 noted that the change to a public entity was, amongst other things, ‘required to; facilitate the use of accreditation by government departments, especially in support of the use of conformity assessment in regulation,

Areas were accreditation is mandatory Inspection field Major Hazard Installation Legal metrology Gas Test station Food Inspection Explosive facilities, equipment and processes Diagnostic X-Ray Imaging System. b) Verification field Mass Volume 11

Areas were accreditation is mandatory Several other areas in process of development: Electrical Inspections Organically Produced Products Health & Safety Lift Inspection 12

Regulators using Accreditation Department of Labour Department of Minerals NRCS – Legal Metrology Department of Health 13

Benefits of using accredited laboratories by Government Increasing confidence in data that is used to establish baselines for key analyses and decisions Reducing uncertainties associated with decisions that affect the protection of human health and environment Increasing public confidence, because accreditation is a recognisable mark of approval Eliminate redundant reviews and improving the efficiency of the assessment process (which may reduce costs) 14

Accreditation Bodies Market Conformity assessment service Demands for facilitating trade Accreditation Bodies Certification Body Inspection Test Lab Cal Product/ service Suppliers Purchasers Regulators Trade Organizations and Authorities Conformity assessment bodies Conforming product/service Requirements Demands for competent conformity assessment Accreditation service

SANAS and Accreditation Peer Evaluation ISO 17011 SANAS Accreditation Government Recognition Testing Laboratory or Medical Laboratories E.g. SAPS, DoH, DAFF, Private Labs ISO 17025 or ISO 15189 Customers E.g. Police Forces, Courts, Farmers, patients Customer Requirements 16

How can one tell that the Lab is technically competent? Technical competence of staff Validity and appropriateness of tests methods Traceability of measurements and calibrations to national standards Suitability, calibration and maintenance of test equipment Test environment Sampling, handling and transportation of test items Quality assurance of test and calibration data 17

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories Scope of ISO/IEC 17025: “…demonstrate that they (laboratories) operate a quality system, are technically competent, and are able to generate technically valid results” “specifies the general requirements for the competence to carry out tests and/or calibrations including sampling” 18

ISO/IEC 17025:2005 vs. ISO 9001 Scope of ISO/IEC 17025: “…demonstrate that they (laboratories) operate a quality system, are technically competent, and are able to generate technically valid results” Scope of ISO/IEC 9001 “aims at confirming the compliance of the management system to this standard, but does not specifically evaluate the technical competence of a laboratory” 19

ISO/IEC 17025:2005 SANAS assess and accredit directly against ISO/IEC 17025 Two main sections – Management Requirements and Technical requirements Used in relation to a variety of types of testing and calibration (flexible in its application) 20

Evaluating Competency for Accredited Laboratories 21

Why competency so important? How do we assess competence? What is competence? Why competency so important? How do we assess competence? What SANAS accreditation is not 22

What is competence? Competence is the demonstrated ability to apply knowledge and skills and where relevant, demonstrated personal attributes to achieve intended results. 23

What is competence? Competence: Skills Knowledge Experience Qualifications Ability 24

Conformity Assessment Body What is competence? Accreditation Body Accreditation (Skills assessment) Conformity Assessment Body Certification (conformity) Laboratory/Client 25

Technical competence of a Lab Technical competence of a lab depends on a number of factors, namely: Qualifications, training and experience of the staff Correct equipment – proper calibrated and maintained Adequate quality assurance procedures Proper sampling practices Appropriate and valid testing procedures and methods Traceability of measurements to national standards Accurate recording and reporting procedures Suitable testing By being accredited, the laboratory is demonstrating that these requirements, amongst others, have been and continue to be met 26

How we assess competence Witnessing Assessment Personnel member has competence for the activity performed Personnel member’s competence are consistent with the records Personnel member has been supplied with all necessary documented calibration/test methods and procedures Procedures are up-to-date Procedures are implemented in full and correctly (no shot cuts) Promptly record of all observations Facilities and equipment are fit for accreditation purpose 27

How we assess competence Advantages of witnessing Valid evidence Direct evidence Authentic evidence Sufficient evidence 28

CASE STUDY 6 29

VERTICAL ASSESSMENT 30

Assuring the Quality of results How we assess competence b) Vertical Assessment Equipment Personnel Environment Test Methods Assuring the Quality of results 31

CASE STUDY 4 32

What SANAS Accreditation is not It is not merely a means of registering or listing someone or something It is not a management system review dressed up with some scientific and technical elements It is not the recognition of future capabilities It is not the recognition of an individual’s qualifications It is not a broad approval of everything a laboratory might do 33

Take home messages Accreditation assessment of a laboratory is an independent assessment (by experts) on the competence of a laboratory to perform tests against a schedule of accreditation” Accreditation confirms technical competence 34

Current Challenges Reviewing of validation documentations before onsite assessment Completion of recommendation form Under utilization of F23 (pink form) Under utilization of the Technical Requirements form (F49) Annotation of Schedule of Accreditation PT plan according to SANAS R80 35

CASE STUDY 5 36

RECOMMENDATION FORM (F04) 37

What should be on the F04? Assessment’s team recommendation A conclusion with respect to the effectiveness of the organisation’s system: - and + Comments on ILC / proficiency testing activities Report shall not be used to express gratitude or ant other sentiment relevant to the assessment 38

Initial Assessment Unconditional accreditation status to be granted Accreditation status to be deferred until non-conformances have been cleared Accreditation not recommended 39

CASE STUDY 2 40

Subsequent Assessments Unconditional maintenance of accreditation status Conditional maintenance of accreditation subject to satisfactory clearance of the non-conformances within stipulated timeframe of 25 working days Conditional maintenance of accreditation subject to an on-site clearance of NC’s within a period of 3 months Suspension of accreditation status 41

CASE STUDY 2 42

Clearance of Findings (P 40) 43

Conditions for recommending an On-site Clearance of Findings Visit Clearance of Findings is only applicable to: A surveillance assessment A 6 months follow-up visit Extension of scope visit, where the extension is within an existing accredited scope 44

Conditions for recommending an On-site Clearance of Findings Visit Clearance of Findings is not applicable to: Initial Assessment Re-Assessments Extension of scope visit, where the extension is for a new scope 45

Conducting the On-site Clearance of Findings Visit The purpose of the on-site clearance of findings is to verify implementation and effectiveness of corrective actions taken by the facility 46

Conducting the On-site Clearance of Findings Visit All evidence and supporting documentation must be submitted to SANAS for perusal and acceptance prior to the on-site COF 47

Conducting the On-site Clearance of Findings Visit Assessment team shall only clear NC’s if evidence supports that proper root cause analysis was undertaken, the CA’s had been effectively implemented and the necessary preventative actions have been put in place Should the team come across additional observations that are not related to the original NC’s, the assessor shall record the issues on the back of the F04. 48

Recommendation/Statement resulting from the Outcome of the CoF Visit If all CA’s are effective and have been satisfactorily implemented, the statement should indicate that “All corrective actions have been implemented” . If any or all of the CA’s have not been cleared, the statement should indicate that “Corrective actions have not been implemented / effectively implemented”. 49

CASE STUDY 3 50

Re-Assessment Unconditional re-accreditation status to be granted Re-Accreditation status to be deferred until non-conformances have been cleared Re-Accreditation not recommended 51

CASE STUDY 1 52

Re-instatement assessment Re-instatement of accreditation status recommended Re-instatement of accreditation subject to satisfactory clearance of the NC’s within the stipulated timeframe of 25 working days Re-instatement of accreditation status not recommended 53

SANAS ADMINISTRATION PROCESSES 54

PROGRAM FINISHES THE ASSESSMENT PLAN ASSESSOR CONFIRMATIONS COMPLETED 31 SEPTEMBER PROGRAM FINISHES THE ASSESSMENT PLAN 24 DECEMBER ASSESSOR CONFIRMATIONS COMPLETED 55

FACILITIES CONFIRMATIONS SECURED 31 MARCH FACILITIES CONFIRMATIONS SECURED 56

4 WEEKS BEFORE THE ASSESSMENT ADMINISTRATOR COMMENCES WITH TRAVEL ARRANGEMENTS 57

3 WEEKS BEFORE THE ASSESSMENT ADMINISTRATOR SENT TRAVEL DOCUMENTATIONS TO RELEVANT ASSESSORS 58

1 WEEKS BEFORE THE ASSESSMENT ADMINISTRATOR CONFIRMS THAT ALL TRAVEL ARRANGEMENTS HAVE BEEN RECEIVED BY THE ASSESSORS 59

4 WEEKS BEFORE THE ASSESSMENT ADMINISTRATOR COMMENCES WITH ASSESSMENT PACK COLLATION 60

2 WEEKS BEFORE THE ASSESSMENT ADMINISTRATOR DISPATCHES THE ASSESSMENT PACKS 61

2 DAYS AFTER DISPATCHING PACKS ADMINISTRATOR CONFIRMS RECEIPT OF PACKS WITH THE ASSESSORS 62

WITHIN 5 WORKING DAYS AFTER THE ASSESSMENT LA / ASSESSOR TO RETURN ASSESSMENT PACKS 63

25 DAYS AFTER THE ASSESSMENT FACILITY SUBMITS COMPLETED CORRECTIVE ACTIONS 64

50 DAYS AFTER THE ASSESSMENT ASSESSMENT PACK CLOSED 65

ASSESSOR CLAIMS 66

ASSESSOR SUBMITS CLAIM FM REVIEWS, SIGNS AND SUBMITS TO FINANCE 67

FINANCE SENT THE CLAIMS TO SM CFO SIGNS AND INSTRUCT THE BANK TO MAKE PAYMENTS 68

Questions Thank You shadrackp@sanas.co.za

Use of Standards in Forensic Science ISO17025 - Laboratory based activities ISO17020 - Scene of Crime activities 70

Guidance Documents ISO17025 – ILAC G19 Guidelines for Forensic Science Laboratories ISO17020 – EA 5/03 Guidance for the implementation of ISO/IEC 17020 in the field of crime scene investigation 71

Forensic Testing Definition of an objective test from ILAC G19 ‘A test which having been documented and validated is under control so that it can be demonstrated that all appropriately trained staff will obtain the same results within defined limits. These defined limits relate to expressions of degrees of probability as well as numerical values.’ 72

Forensic Testing Objective tests will be controlled by: Documentation of the test Validation of the test Training and authorization of staff Maintenance of equipment And where appropriate Calibration of equipment, use of appropriate reference materials, provision of guidance for interpretation, checking of results, testing of staff proficiency, recording of equipment / test performance 73

Forensic Laboratory The term laboratory is often used to mean:- or The organisation being assessed or The facilities where relevant activities are being carried out e.g. garage / workshop / office/ firing range/photographic studio 74

Areas currently accredited include:- Drugs Body Fluids 75

Questions Thank You shadrackp@sanas.co.za