Topics • Assessor seminar feedback • Laboratory feedback • Sampling of tests for assessment • New/revised requirements of 17025 • Statistics on non-conformities • Empirical in-house methods
Feedback - last assessor seminar • Fulfilling assessors’ need and expectation • Duration • Gain from the seminar
Feedback - last assessor seminar • 127(110) assessors attended • 84(48) evaluation forms returned • Fulfilling assessors’ need and expectation • 0 (0) % not really, 23 (31)% adequately, 57 (65) % well, 20 (4) % very well • Duration • 0 (0) % too long, 96 (98) % suitable, 4 (2) % too short
112 comments received Grading of non-conformities (9) Views and experience of assessors (17) Latest development of HKAS (24) Technical issues, eg PT, MU, etc (6) Feedback - gain
24 suggestions received More assessor workshops Longer discussion More technical seminars Feedback – suggestions on future activities
Laboratory Feedback • September 2005 • All accredited organisations • Accredited labs – 128 • Return (labs) – 55 = 43%
Laboratory Feedback- Degree of rigor • Substantially relaxed – 0% • Slightly relaxed – 29.5% • Remained unchanged – 67.2% • Slightly tightened – 3.3% • Substantially tightened – 0%
Laboratory Feedback- Degree of rigor • Depending on the availability of technology available in the market, some equipment, specifications or requirements stated in testing standard that cannot be fulfilled should be duly accepted. Surely it can be reviewed again per the advancement of technology.
Laboratory Feedback- Degree of rigor • More flexibility to be given for quoting accreditation to a standard with modification for those modified method verified with same level of performance characteristics.
Laboratory Feedback- Degree of rigor • Consistency on technical/quality requirements between different assessors should be aligned. • Sometimes, the corrective actions taken for non-conformities raised in the previous assessment may not be accepted in the next assessment.
Laboratory Feedback- Degree of rigor • It can help to maintain lab standard. • I like officer be tighten on the quality system.
Laboratory Feedback- Degree of rigor • It seems that the assessment is too concentrated on minor points rather than major issues.
ISO/IEC 17025:2005 • Published on 15 May 2005 • 8th edition of HOKLAS 003 published in October 2005 • Full implementation by 15 May 2007 by accredited laboratories • No extra assessment to be conducted • Amendment mainly on Section 4 (Management requirements)
HOKLAS 003 8th edition • Section 1 Introduction - Updated • Section 2 Normative references – New • Section 3 Terms and definitions – New • Sections 4 & 5 – revised as per ISO/IEC 17025:2005 • Section 5 Technical requirements – only two revised/new clauses
Section 5 HOKLAS 003 8th edition Clause 5.2.2 Personnel • …. The effectiveness of the training actions taken shall be evaluated. Clause 5.9.2 Assuring the quality of test and calibration results • Quality control data shall be analysed and, where they are found to be outside pre-defined criteria, planned action shall be taken to correct the problem and to prevent incorrect results from being reported..
HOKLAS 003 8th edition • Section 1 Introduction Compliance with regulatory and safety requirements on the operation of laboratories is not covered by this International Standard. • Section 5.3.H It should be emphasized that it is the responsibility of the laboratory to ensure that its operation is in compliance with all applicable regulations, particularly those related to laboratory safety.
HOKLAS 003 8th edition • Section 4.9.H Control of nonconforming testing and/or calibration work Examples – • environmental conditions exceeded limits; • duration of conditioning of test specimens not complying with specifications; • max. holding times of samples exceeded; • tests performed using instruments with expired calibration; • QC acceptance limits exceeded; • performance in PT unsatisfactory
HOKLAS 003 8th edition • Section 4.13.H Control of records The retention period of at least 3 yrs for equipment records and lab. operation procedures shall be counted from the date on which the use of the equipment or the operation procedures have been discontinued respectively. Similarly, the retention period of at least 3 yrs for personnel records shall be counted from the date of departure of the staff member concerned.
Sampling of tests for assessment ISO/IEC 17011:2004 Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies
Sampling of tests for assessment Cl. 7.5.6 Preparation for assessment The accreditation body shall establish procedures for sampling (if applicable) where the scope of the CAB covers a variety of specific conformity assessment services. The procedures shall ensure that the assessment team witness a representative number of examples to ensure proper evaluation of the competence of the CAB
Sampling of tests for assessment • Cl. 7.6.1 Document and record review The assessment team shall review all relevant documents and records supplied by the CAB… to evaluate its system, as documented, for conformity with the relevant standard(s) and other requirements for accreditation • Cl. 7.7.3 On-site assessment The assessment team shall witness the performance of a representative number of staff of the CAB to provide assurance of the competence of the CAB across the scope of accreditation.
Sampling of tests for assessment • HKAS Management Manual App 9.4A5 …Emphasis should be given to new activities to be accredited and activities and aspects which are known to be problematic, e.g. activities with poor proficiency testing results or performed in accordance with standards which are known to have different interpretations, subjects of complaints, aspects where many non-conformities were identified in previous assessments, etc….
Sampling of tests for assessment • HKAS 008 Guide for HKAS Assessors and Lead Assessors Clause 7.3.1 Observing of the Organisation’s Practice The assessment team should witness some or all of the tests … within the scope of accreditation.… Even if a particular test … is too lengthy to be performed in its entirety during the visit, it should be possible for at least the most critical phases of the test … to be performed…Depending upon the circumstances, samples or specimens used in such tests … may be conveniently drawn from the normal work throughput … or provided by a member of the assessment team through arrangement with the team leader.
Sampling of tests for assessment • Difficult to have hard and fast rules • Random sampling is not the most appropriate • Priority for those not assessed before • At least select a representative test in each test area
Sampling of tests for assessment • Like driving test – select those that need special skills and knowledge • Like an examination, select those tests which are most indicative of lab’s competence • Like cooking class, if the test is solely for demonstration purpose, skip those non-critical steps • More than one test can be performed at a time • Prior arrangement with the lab is helpful
Laboratory internal validation and verification Laboratory requirement Verification (Secondary validation) Validation Validation Validation (Primary validation) Existing information Fully validated standard methods (have been studied in a collaborative trail) Standard methods – amplifications and modifications e.g. new instrument Standard methods – outside their intended scope Laboratory – developed and non-standard methods
Definition • Validation is the confirmation, through provision of objective evidence, that the particular requirements for a specific intended use or application have been fulfilled (ISO/IEC 17025 clause 220.127.116.11 and ISO 9000:2000) • Verification is the confirmation, through provision of objective evidence, that specified requirements have been fulfilled. (ISO 9000:2000) • Objective evidence is data supporting the existence or verity of something (ISO9000:2000)
Standard methods shall be verified for 1. Procedures conformity with the standard method 2. Availability and suitability of equipment and reference materials/standard, reagents, etc 3. Appropriateness of environmental conditions 4. Competence of testing staff 5. Capability of lab of achieving the defined method performance characteristics
Main validation parameters • Applicability • Selectivity • Calibration and linearity • Trueness • Precision
Main validation parameters • Recovery • Working concentration and measurement range • Limit of Detection (LOD) and Quantitation (LoQ) • Matrix variation • Measurement Uncertainty
Common insufficiencies 1. Method bias not established or demonstrated 2. Precision data derived from short term results and do not cover major variations 3. Detection limits wrongly determined 4. Major components omitted in measurement uncertainty estimation
Empirical Methods • Definition – the quantity estimated is simply the result found on following the stated procedure.Hence, method bias is zero and matrix variation is irrelevant. However, laboratory bias need to be assessed. Apart from these, method validation similar to other rational methods. Empirical methods are often defined by standard methods or legislation.
In-house Methods • Definition –methods other than standard methods and which are designed/developed by the laboratory. • Full method validation required
In-house Empirical Methods • For some measurands (analytes), their values are defined by the procedure used, which may be given in standard methods, in legislation or by users of testing service. Many commonly encountered measurands determined by empirical methods have established meanings, e.g. BOD, COD, SS, VS, etc.
In-house Empirical Methods • For these measurands, in-house empirical methods need to show comparability with the those defined in well recognised standard methods. • Very often, in-house empirical methods are modified standard methods. Ensure the modifications do not affect the values obtained, based on professional judgement and validation data (e.g. CRM, PT, comparison with relevant standard methods, etc.).
In-house Empirical Methods • May need to define the measurands or give key experimental conditions in test reports, e.g. extraction conditions for metals (temperature, duration, acid strength, etc.), drying temperature of suspended solids, etc. • Customer specified in-house empirical methods – precision need to be demonstrated