Laboratory Quality Assurance Manager & Laboratory Assessor RULES & HANDBOOK

Transcription

1 EOQ Personnel Registration Scheme Laboratory Quality Assurance Manager & RULES & HANDBOOK Prepared by: Dr. Eugenia Soboleva, Quality Austria In accordance with the working group on EOQ product development

2 EOQ Registration Scheme, Rules & Handbook Laboratory Quality Assurance Manager and Contents CHAPTER A: The EOQ Personnel Registration Scheme A.1 Target A.2 References CHAPTER B: Definitions B.I EOQ Laboratory Quality Assurance Manager B.II EOQ CHAPTER C: Job specifications C.I EOQ Laboratory Quality Assurance Manager 1. Preconditions 2. Personal attributes 3. Capabilities after the relevant training courses C.II EOQ 1. Preconditions 2. Personal attributes 3. Capabilities after the relevant training courses C.III EOQ Personnel Registration Scheme for Laboratory Quality Assurance Manager and CHAPTER D: Personnel Qualification / Registration D.I Foreword D.II Qualification Criteria for Laboratory Quality Assurance Manager 1. Laboratory Quality Management System 2. Organisation of Quality Management Functions 3. Process management principles and improvement techniques 4. Resource management 5. Quality Assurance and Quality Documentation 6. Validation and adaptation of testing procedure 7. Uncertainty measurements 8. Quality Control 9. Calibration and Traceability

3 EOQ Registration Scheme, Rules & Handbook Laboratory Quality Assurance Manager and 10. Proficiency Testing 11. Social aspects 12. Legal and regulatory aspects D.III Qualification criteria for (Based on ISO 19011) 13. General items 14. Planning and preparation of laboratory assessment programmes 15. Assessment process 16. Reporting 17. Follow up 18. Qualification of s APPENDIX 1 Candidate Prerequisites for Training Courses

4 EOQ Registration Scheme, Rules & Handbook Laboratory Quality Assurance Manager and CHAPTER A: The EOQ Personnel Registration Scheme A.1 Target 1. Creation of an EOQ scheme for the registration and certification of: EOQ Laboratory Quality Assurance Manager EOQ A.2 References 1. The EOQ Personnel Registration Scheme, Rules and Handbook, January Guidelines for selection of participants o Courses for the Training of Assessors involved in Assessments of Laboratories Applying for Accreditation, Europeans Organization for Accreditation of Laboratories, EAL-G8, November Guidelines for training courses for Assessors used by Laboratory Accreditation Schemes, EAL-G7, September 1993

5 EOQ Registration Scheme, Rules & Handbook Laboratory Quality Assurance Manager and CHAPTER B: Definitions B.I EOQ Laboratory Quality Assurance Manager The EOQ Laboratory Quality Assurance Manager has the ability to install, maintain and improve Laboratory Quality Management System that meets the requirements of ISO/IEC Standard and OECD GLP, and applicable for the laboratories of any size and any activities related to calibration and testing. The EOQ Laboratory Quality Assurance Manager has the ability to act as the management representative and as the promoter of the customer requirements awareness throughout the organisation. B.II EOQ The EOQ is qualified as EOQ Laboratory Quality Assurance Manager (see above). In addition, the EOQ has a sound and current knowledge of auditing practice and the capability to apply the necessary management skills required in the execution of an audit, as called for in ISO 19011:2002. The EOQ will be able to perform internal and third party audits proving conformance with the relevant standards and technical recommendations (e.g. ISO 17025:2005 and OECD GLP) taking laboratory orientation into account where necessary.

6 EOQ Registration Scheme, Rules & Handbook Laboratory Quality Assurance Manager and CHAPTER C: Job specifications C.I EOQ Laboratory Quality Assurance Manager 1. Preconditions 1.1. The candidates for EOQ Laboratory Quality Assurance Manager category should hold a university degree or equivalent in a relevant scientific or technological discipline. To cope with a variety of national education systems, the definition of equivalence to a university degree is left to the discretion of the EOQ-PRU Agent participating in the Scheme Before qualifying as an EOQ Laboratory Quality Assurance Manager, the candidates should have accumulated appropriate practical workplace training and experience over a minimum period of two years, in a laboratory and/or technical fields covered by the activities of the laboratory applying for accreditation. 2. Personal Attributes EOQ Laboratory Quality Assurance Manager should be open-minded, quality-minded, honest, loyal, skilled and ready to accept and to learn new techniques. They should have both analytical skills and managerial abilities; they should be committed to continuous improvement. They should be able to work in teams, and they should be cost conscious. The successful candidate shall give written evidence of education, practical experience and professional background. 3. Capabilities after the relevant training courses The EOQ Laboratory Quality Assurance Manager shall be competent in Laboratory scopes, techniques and management methods, including: Quality system principles Quality documentation and records Supporting management commitment and review, Review and evaluation of quality related costs considerations Customer care systems, satisfaction monitoring and evaluation QMS planning,

7 EOQ Registration Scheme, Rules & Handbook Laboratory Quality Assurance Manager and Compatibility with other management systems (eg. ISO 9001, ) Project management, design planning and review Quality data information systems/communications Use of statistical methods Evaluation of statistical methods, data collection and analysis Quality of Resources Quality Assurance/Quality Control Quality of processes Validation and adaptation of testing procedure Measurement Uncertainty Calibration and Traceability Management of measuring and test equipment Treatment of nonconformities, corrective and preventive action programs QMS continual improvement process and review Quality motivation and quality improvement programs EOQ Laboratory Quality Assurance Manager shall have the ability to install, maintain and improve Laboratory Quality Management System that meets the requirements of ISO/IEC Standard and OECD GLP, and applicable for the laboratories of any size and any activities related to calibration and testing. The EOQ Laboratory Quality Assurance Officer has the ability to act as the management representative responsible for the quality management system implementation. They shall be able to perform Laboratory assessments, to act as internal auditor and to be partners for external auditors.

8 EOQ Registration Scheme, Rules & Handbook Laboratory Quality Assurance Manager and C.II EOQ Preconditions 1.1. The candidates for EOQ shall have met the qualification requirements of the EOQ Laboratory Quality Assurance Manager (see Chapter C.I). Before qualifying as an EOQ, the candidates should have accumulated appropriate practical work-place training and experience over a minimum period of five years, at calibration or testing laboratory or in technical fields covered activities of the laboratories applying for accreditation. The number of practical work-place experience can be reduced by one year if person has completed appropriate post-secondary education. In addition, the candidates should have at least two years' practical experience in quality assurance and/or management activities. Prior to the qualification, the candidates shall undergo training in the conduct and management of audits. They should also have practical experience on the assessor side of at least four laboratory assessments, comprising not less than 20 assessment days. The assessments should be completed within the last three years prior to the registration & certification. After qualification, the candidate shall read the current EOQ Code of Professional Conduct (Appendix 1 PRU Handbook) and declare by signing it that he / she will entirely abide by its clauses. 2. Personal attributes EOQ s should be open-minded, quality-minded, honest, and mature. They should have both analytical skills and managerial abilities; sound judgement, diplomacy, tenacity, decisiveness, integrity, and the ability to perceive situations in a realistic way. The successful candidate shall give written evidence of education, practical experience and professional background. 3. Capabilities after the relevant training courses 3.1. EOQ s shall be competent in all quality assurance/quality control measures, required for EOQ Laboratory Quality Assurance Managers. Before recognising an individual as an EOQ, the EOQ should ascertain that the candidate is able to carry out a laboratory audit. This involves the ability to:

9 EOQ Registration Scheme, Rules & Handbook Laboratory Quality Assurance Manager and Obtain and assess factual evidence needed for an assessment of an applicant for accreditation fairly Apprise these findings objectively, taking into account the practical conditions of each individual case Remain true to the purpose of the audit without fear of favour Perform the audit process without deviating due to distractions Commit full attention and support to the audit process Commit reasonable care in all matters of the audit report The EOQ shall have interpersonal skills, as demonstrated through the ability to: Constantly evaluate the effects of audit observations and personal interactions during an audit process Treat personnel concerned in a way that will best achieve the audit purpose Fulfil the audit objectives using defined methods and techniques Practical illustrations of the EOQ s personal attributes may be demonstrated by the individual's ability to: Plan and manage audit process competently, free of bias and any conflict of interest Organize teamwork Lead a team React effectively in stressful situations. Arrive at generally acceptable conclusions based on audit observations and evidence. Present the findings of an assessment in unambiguous terms and in a reasonably structured report Remain true to a conclusion under pressure to change that is not based on evidence. Keep discretion between the auditee, client and audit team members.

10 EOQ Registration Scheme, Rules & Handbook Laboratory Quality Assurance Manager and EOQ shall have a sound and current knowledge of auditing practice and the capability to apply the necessary management skills required in the execution of an audit, as called for in ISO 19011:2002. They shall be able to perform third party audits proving conformance with the relevant standards of the ISO and/or GLP, taking laboratory orientation into account where necessary. C.III EOQ Personnel Registration Scheme for Laboratory Quality Assurance Managers and s Summary of Education and Training Requirements UNIVERSITY DEGREE OR EQUIVALENT RECOGNIZED TRAINING ORGANIZATION Training (app. 80 hrs) including 24 hrs audit training BODY FOR CERTIFICATION OF THE RECOGNIZED EOQ AGENT Evaluation as EOQ Laboratory Quality Assurance Manager Training Course (app. 16 hrs) Requirements acc. to ISO Evaluation as Laboratory Assessor and evidence of 4 audits (20 days)

11 EOQ Registration Scheme, Rules & Handbook Laboratory Quality Assurance Manager and CHAPTER D: Personnel Qualification / Registration D.I Foreword This chapter illustrates the conditions to which the training of Quality Personnel should be subjected, in order to provide the levels of qualification, required by the EOQ Personnel Registration Scheme. The aim is to reach wide acceptance not only in Europe but also throughout the world. It is outside the purpose of this Scheme to standardise the training of quality personnel. Instead it intends to harmonise the relevant procedures, so that a level of qualification, acceptable in all countries, is set. The Scheme leaves enough freedom to take into account national requirements, conditions and quality culture. It is based on trust and confidence and it does not put less, it puts even more, responsibility on the participating EOQ-PRU Agent. D.II Qualification Criteria for Laboratory Quality Assurance Managers Key A To understand and to be able to explain B C In addition to A, to be able to indicate relevant methods and to apply them In addition to A and B, to elaborate and integrate relevant methods and to interpret the results EOQ Laboratory Quality Assurance Manager 1 Laboratory Quality Management System 1.1 Basic management principles: B Decision making Planning Organising Human Resources Reviewing 1.2 Quality management principles: C Importance of systematic quality approach for society, producer, consumer, government and for the environment, economy and trade. Use of quality management principles. Compatibility of quality management system with other management systems. 1.3 Concepts: B

12 EOQ Registration Scheme, Rules & Handbook Laboratory Quality Assurance Manager and Quality, tested once accepted everywhere, performance of a method, fitness for purpose, degree of confidence of the analytical results, customer focus, continual quality improvement, total quality management. Laboratory auditing. 1.4 Quality Policy: B Quality as a management task, quality objectives. Management by quality objectives: quality policy formulation and quality information. Vision and Mission. Strategy and policy, objectives and operational objectives. Standardisation, planning, and reporting. 1.5 Organisational concepts: C Organisational principles and relevant procedures and rules. Organisational structures of responsibilities, tasks and competencies. The role and responsibilities of Quality Assurance Managers, technical managers, and laboratory personnel. Their functional requirement and position in the organisation. Hierarchy and lines of reporting System-approach of managing organisations: B Models of management, effectiveness and efficiency, management of studies and projects. 1.7 Management Commitment: B Integration of: aspects and tools. Commitment to customer and regulatory requirements. Management reviews, resources availability. 1.8 Standards and guidelines: C ISO, EN and OECD standards and guidelines concerning quality management system for the laboratories, vocabulary, accreditation and certification systems auditing

13 EOQ Registration Scheme, Rules & Handbook Laboratory Quality Assurance Manager and 2. Organisation of the Quality Management Functions 2.1 Organisation: C Organising delegation of responsibilities and co-ordination of tasks. Roles and responsibilities of Quality personnel. Roles of technical managers and laboratory personnel within the quality management system. Co-ordination mechanism: objectives, structure, procedures and committees/boards. 2.2 Auditing: B Auditing and review of the quality organisation, and product, process and systems audits, and principles of interview techniques. 3 Process management principles and improvement techniques C 3.1 Process identification, Process planning, Process management, Process measurement and improvement 3.2 Organisation of an investigation: B Planning, budgeting and progress control. Quality control tools in calibration and testing processes. 3.3 Motivation: B Theories of motivation in relation to quality implementation 3.4 Techniques: B Planning of studies, specification/ description of objectives of studies and tests, setting up quality performance indicators, plan-do-check-act cycle. 3.5 Observation: C Observation and record of errors. 3.6 Interpretation: C Interpretation of results of observations.

14 EOQ Registration Scheme, Rules & Handbook Laboratory Quality Assurance Manager and 3.7 Customer complaints B 3.8 Corrective and preventive actions, B 3.9 Benchmarking: B Inter-laboratory comparison and proficiency testing objective and principles. 4. Resource management 4.1 Analysis of the need for competence, education and training: B Integration of internal training programs from top to bottom, identification for short and long-term training needs and specification and organisation of training programs. 4.2 Evaluate effectiveness of training; B ensure awareness of relevance and importance of their activities; maintain records of education, experience, training and qualification. 4.3 Work environment B 5. Quality Assurance and Quality Documentation 5.1 Quality Assurance and Quality Control B Tools and definitions. 5.2 QMS documentation: C Documentation hierarchy, Quality Manual, Standard operating procedures, Study plans, Job descriptions, forms, templates and checklists. 5.3 Reporting and Archiving. C Responsibilities. Security of documentation and records. Customer confidentiality. 6. Validation and adaptation of methods 6.1 Method validation requirements; Fitness for purpose B Validation of methods by inter-laboratory study; 'Single-laboratory' or 'In-house method validation;

15 EOQ Registration Scheme, Rules & Handbook Laboratory Quality Assurance Manager and 6.2 The performance characteristics of the method: B Applicability, specificity, selectivity, linearity, accuracy, trueness, bias, precision, calibration range, LOD, LOQ sensitivity, ruggedness. 6.3 Statistics used for method validation: B Significance testing, analysis of variances, 6.4 Building Method Validation protocol; B Establishment of within laboratory performance; Internal quality control requirements to method validation; Verification of the performance of the method during its regular use; Adaptation of a validated method in another laboratory; Method performance characteristics and estimation of uncertainty using method validation data 7. Uncertainty measurements 7.1 Types of errors in analytical measurements: B Gross, random and systematic errors 7.2 Process of uncertainty estimation B Methods for estimation of uncertainty Top-down and bottom-up approaches: advantages and drawbacks Identification of the uncertainty sources; Quantifying the uncertainty component; Converting to standard uncertainties; Quantifying combined uncertainty. 7.3 Consideration of the bias of the measurement B 7.4 Reporting the results of measurements and estimated uncertainty 7.5 Interpreting the results of measurements B Practical consequences of variability of the results Possible actions to reduce the uncertainty 8. Quality Control for Laboratories 8.1 Quality Control Measures C Tools and definitions 8.2 Implementation of Internal Quality Control measures; C

16 EOQ Registration Scheme, Rules & Handbook Laboratory Quality Assurance Manager and Control charts, replicate analytical portions, Repeated tests, blanks, and blind samples 8.3 Use of Reference materials and analytical standards; C 8.4 Possibilities of controlling various analytical steps: B sampling, sample preparation and processing, extraction and cleanup 8.5 Instrumental analysis: B suitability of tests and calibration equipment, uncertainty arising from calibration, minimization of uncertainty arising form calibration 8.6 Inter-laboratory quality control measures: C proficiency testing schemes, inter-comparison studies, collaborative studies 8.7 Reporting of results, rounding of data C 9. Calibration and traceability 9.1 Traceability concept B International System of Quantities and Units (SI) Traceability of a measuring standard Certified reference material (CRM) and reference materials (RM): terminology, types, production, and uses. Hierarchy of Analytical standards Selection and use of analytical standards 9.2 Traceability of equipment: B calibration, history of usage, long-term performance, suitability for usage 9.3 Traceability of analytical method: B method selection, development, validation and verification 9.4 Traceability of the results and QA system B Laboratory sample reception, verification Documentation of the laboratory work 10. Proficiency testing 10.1 Operation principle of Proficiency Testing schemes B

17 EOQ Registration Scheme, Rules & Handbook Laboratory Quality Assurance Manager and Different types of PT schemes Selection of appropriate PT scheme Data processing in PT schemes Performance criteria Individual laboratory performance 10.2 Formulation and Implementation of corrective actions C 11. Social aspects 11.1 Personnel satisfaction: A 11.2 Communication, general: A Management of change. Laboratory campaigns. Management style/culture and corporate identity External communication: B Effective communicating with a) suppliers, contractors and subcontractors; b) customers; c) legal authorities; d) other relevant organisations Internal communication C Knowledge and information to the personnel having an impact on Laboratory concerning followings: a) development and validation of new methods; b) chemicals, equipment and services; c) laboratory premises, location of equipment, environment; d) cleaning and sanitation programmes; f) transport, and storage systems; g) regulatory requirements; h) knowledge regarding laboratory hazards and control measures; I) safety of laboratory operation 12. Legal and regulatory aspects Legislation: B National and international legislation Regulatory aspects: B National and international regulation. Accreditation and certification Laboratory management standards C

18 EOQ Registration Scheme, Rules & Handbook Laboratory Quality Assurance Manager and D.III Qualification Criteria for s (Based on ISO 19011:2002 and ISO/CD 22000:2003) Key A To understand and to be able to explain B In addition to A, to be able to indicate relevant methods and to apply them C In addition to A and B, to elaborate and integrate relevant methods and to interpret the results EOQ Laboratory Quality Assurance Manager EOQ Laboratory Assessor Level 13. General items Certification standards and guidelines: B C ISO 19011; ISO/IEC 17025; ISO 9001; ISO 9004; and subsequent drafts and valid revisions Accreditation standards A A Fundamentals of auditing B C Psychological aspects A B Certification A C 14. Planning and preparation of food safety system audit programme Preparing and managing an audit programme B C Roles and responsibilities of assessor, auditee and client B C Audit programme records, audit plans B C Preparation and use of checklist B C Combined system audits, joint audits A C Audit programme review and monitoring B C

19 EOQ Registration Scheme, Rules & Handbook Laboratory Quality Assurance Manager and 15. Audit process activities Initiating the audit. Feasibility of the audit C C Establishing the audit team C C Preparatory meeting C C Initial document review C C On-site audit activities planning C C On-site audit activities C C Interview techniques B C Communication with the client and auditee A C Collecting evidence C C Documentation of audit observations C C Non-conformities C C Closing meeting C C Corrective actions C C 16. Reporting Preparation of the report B C Content of the report B C Approval and distribution of the report B C Retention of the report/documents C C Confidentiality B C 17. Follow up Repetition of audits B C Surveillance B C Follow-up corrective action B C 18. Qualification of Laboratory Quality Assessors Education, training and registration as Laboratory Quality Assessor A C Education, training, work and audit experience A C Personal attributes A C Areas of auditor competence A C Maintenance of qualification, assessor evaluation process A C