1. NCSLI 2007 Training Records from an Auditors Viewpoint Shawn Mason Boston Scientific

2. Topics Covered Some of the topics covered in this paper are: Some of the topics covered in this paper are: Training goals Training goals Training goals or needs relevant to the present and anticipated tasks of the laboratory Training goals or needs relevant to the present and anticipated tasks of the laboratory Competency Competency Ensures competency through interim testing and proficiency testing Ensures competency through interim testing and proficiency testing Qualified on the basis of appropriate training, education, experience, and or demonstrated skills to support the scope Qualified on the basis of appropriate training, education, experience, and or demonstrated skills to support the scope Current job descriptions of the laboratory personnel Current job descriptions of the laboratory personnel Authorization Authorization Authorize specific personnel to perform particular types of calibration, issue calibration certificates, give opinions and interpretations and to operate particular types of equipment Authorize specific personnel to perform particular types of calibration, issue calibration certificates, give opinions and interpretations and to operate particular types of equipment Training effectiveness Training effectiveness Evaluation of the effectiveness of the training action Evaluation of the effectiveness of the training action Training forms/matrix Training forms/matrix Examples of a few training forms and a training matrix Examples of a few training forms and a training matrix Training Records Training Records What should be included in a training record What should be included in a training record

3. Training Goals Definition Training goals or needs relevant to the present and anticipated tasks of the laboratory Training goals or needs relevant to the present and anticipated tasks of the laboratoryStandard Section 5.2.2 of ANS/ISO/IEC 17025:2005 (E) Section 5.2.2 of ANS/ISO/IEC 17025:2005 (E) The management of the laboratory shall formulate the goals with respect to the education, training and skills of the laboratory personnel. The management of the laboratory shall formulate the goals with respect to the education, training and skills of the laboratory personnel. The laboratory shall have a policy and procedure for identifying training needs and providing training of personnel. The laboratory shall have a policy and procedure for identifying training needs and providing training of personnel. The training programme shall be relevant to the present and anticipated tasks of the laboratory. The training programme shall be relevant to the present and anticipated tasks of the laboratory.

4. Training Goals Requirement The goals with respect to education, training and skills must be part of the laboratory’s documented record system and are usually within the records of the staff’s performance reviews. The goals with respect to education, training and skills must be part of the laboratory’s documented record system and are usually within the records of the staff’s performance reviews. A policy and procedure is required that identifies the training needs and provides the training of the personnel. A policy and procedure is required that identifies the training needs and provides the training of the personnel.

5. Training Goals Objective Evidence A policy and procedure is required that identifies the training needs (goals) and provides the training of the personnel. A policy and procedure is required that identifies the training needs (goals) and provides the training of the personnel.

6. Training Goals Company Name or Logo TRAINING GOALS For 2007 NAME: __________________________________ POSITION: _______________________________ GOAL: 1) Attend at least one NCSLI Twin Cities Section Meeting GOAL: 2) Take a Dimensional Calibration class GOAL: 3) Attend the NCSLI International Conference GOAL: 4) Write a Technical paper and present it at the NCSLI International Conference GOAL: 5) Attend a NCSLI committee meeting at the NCSLI International Conference

7. Competency Definition Ensures competency through interim testing and proficiency testing Ensures competency through interim testing and proficiency testing Qualified on the basis of appropriate training, education, experience Qualified on the basis of appropriate training, education, experience Or demonstrated skills to support the scope Or demonstrated skills to support the scope Current job descriptions of the laboratory personnel Current job descriptions of the laboratory personnel

8. Competency Standard Section 5.2.1 of ANS/ISO/IEC 17025:2005 (E) Section 5.2.1 of ANS/ISO/IEC 17025:2005 (E) The laboratory management shall ensure the competence of all who operate specific equipment, perform tests and/or calibrations, evaluate results, and sign test reports and calibration certificates. The laboratory management shall ensure the competence of all who operate specific equipment, perform tests and/or calibrations, evaluate results, and sign test reports and calibration certificates.

9. Competency Standard Section 6.1.2 of EN/ISO 10012:2003 Section 6.1.2 of EN/ISO 10012:2003 The management of the metrological function shall ensure that personnel involved in the measurement system have demonstrated their ability to perform their assigned tasks. The management of the metrological function shall ensure that personnel involved in the measurement system have demonstrated their ability to perform their assigned tasks.

10. Competency Standard Section 6.2.2 ISO/FDIS 13485:2003 (E) Section 6.2.2 ISO/FDIS 13485:2003 (E) Determine the necessary competence for personnel performing work affecting product quality Determine the necessary competence for personnel performing work affecting product quality

11. Competency Requirement Technical personnel must have demonstrable knowledge and skills to perform calibrations or tests and compute results. Technical personnel must have demonstrable knowledge and skills to perform calibrations or tests and compute results. They may be asked to demonstrate tests or specific techniques as part of an assessment. They may be asked to demonstrate tests or specific techniques as part of an assessment.

12. Competency Some Accrediting bodies may require that all calibration technicians hold a (CCT) Certified Calibration Technician certificate from ASQ. Some Accrediting bodies may require that all calibration technicians hold a (CCT) Certified Calibration Technician certificate from ASQ.

13. Competency Objective Evidence Training record that includes the following: Qualification of technician’s can come from the following sources: Qualification of technician’s can come from the following sources: Education Education Training classes from a college Training classes from a college College degree College degree College diploma College diploma College certification College certification Quality certification (CCT) Quality certification (CCT) Experience Experience Years of experience in the field (Resume) Years of experience in the field (Resume) Knowledge Knowledge On the job knowledge On the job knowledge Skills Skills On the job skills On the job skills

14. Competency Defines the employee’s job title, principle job responsibilities and annual review signatures

15. Authorization Definition Authorize specific personnel to perform particular types of calibrations Authorize specific personnel to perform particular types of calibrations Issue calibration certificates Issue calibration certificates Give opinions and interpretations Give opinions and interpretations Operate particular types of test and measuring equipment Operate particular types of test and measuring equipment

16. Authorization Standard Section 5.2.5 of ANS/ISO/IEC 17025:2005 (E) Section 5.2.5 of ANS/ISO/IEC 17025:2005 (E) The management shall authorize specific personnel to perform particular types of sampling, test and/or calibration, to issue test reports and calibration certificates, to give opinions and interpretations and to operate particular types of equipment. The management shall authorize specific personnel to perform particular types of sampling, test and/or calibration, to issue test reports and calibration certificates, to give opinions and interpretations and to operate particular types of equipment.

17. Authorization Requirement The laboratory shall maintain records of relevant authorizations The laboratory shall maintain records of relevant authorizations Competence Competence Educational and professional qualifications, training, skills Educational and professional qualifications, training, skills Experience of all technical personnel, including contracted personnel Experience of all technical personnel, including contracted personnel The training record should also include the date on which authorization and/or competence is confirmed The training record should also include the date on which authorization and/or competence is confirmed

18. Authorization Objective Evidence Objective Evidence Training matrix form Training matrix form Job description stating what the staff is authorized to perform Job description stating what the staff is authorized to perform

19. Authorization

20. Authorization

21. Training Effectiveness Definition Evaluation of the effectiveness of the training action completed. Training effectiveness is the assessment of the transfer of knowledge and skills, and is determined on an ongoing basis. Evaluation of the effectiveness of the training action completed. Training effectiveness is the assessment of the transfer of knowledge and skills, and is determined on an ongoing basis.

22. Training Effectiveness Standard Section 5.2.2 of ANS/ISO/IEC 17025:2005 (E) The effectiveness of the training actions taken shall be evaluated. The effectiveness of the training actions taken shall be evaluated.Standard Section 5.2.2 of ANS/ISO/IEC 17025:2005 (E) The effectiveness of the training actions taken shall be evaluated. The effectiveness of the training actions taken shall be evaluated.Standard Section 6.2.2 ISO/FDIS 13485:2003 (E) Evaluate the effectiveness of the actions taken. Evaluate the effectiveness of the actions taken.

23. Training Effectiveness Requirement The evaluation is not to be done for the laboratories program as a whole, but rather is to be done to determine the effectiveness of individual training actions that are taken for the laboratory personnel in relation to the goals that were to have been established for them. The evaluation is not to be done for the laboratories program as a whole, but rather is to be done to determine the effectiveness of individual training actions that are taken for the laboratory personnel in relation to the goals that were to have been established for them.

24. Training Effectiveness Objective Evidence Training records Employee performance reviews Employee performance reviews Results of proficiency testing results Results of proficiency testing results Internal and external audits Internal and external audits

25. Training Effectiveness

27. Training forms/matrix Examples of a few training forms, job description and a training matrix are presented in this presentation. Examples of a few training forms, job description and a training matrix are presented in this presentation.

28. Training Records Training records are considered a quality record and at a minimum the following should be documented: Training goals Training goals Training goals or needs relevant to the present and anticipated tasks of the laboratory Training goals or needs relevant to the present and anticipated tasks of the laboratory Competency Competency Ensures competency through interim testing and proficiency testing Ensures competency through interim testing and proficiency testing Qualified on the basis of appropriate training, education, experience, and or demonstrated skills to support the scope Qualified on the basis of appropriate training, education, experience, and or demonstrated skills to support the scope Current job descriptions of the laboratory personnel Current job descriptions of the laboratory personnel Resume Resume

29. Training Records Authorization Authorization Authorize specific personnel to perform particular types of calibration, issue calibration certificates, give opinions and interpretations and to operate particular types of equipment Authorize specific personnel to perform particular types of calibration, issue calibration certificates, give opinions and interpretations and to operate particular types of equipment Training effectiveness Training effectiveness Evaluation of the effectiveness of the training action Evaluation of the effectiveness of the training action Training forms/matrix Training forms/matrix Examples of a few training forms and a training matrix Examples of a few training forms and a training matrix Training Records Training Records Includes all the documents above Includes all the documents above

30. Training Records Standard Section 5.2.5 ANSI/ISO/IEC 17025:2005 (E) Section 5.2.5 ANSI/ISO/IEC 17025:2005 (E) The laboratory shall maintain records of relevant authorizations, competence, educational and professional qualifications, training, skills, and experience of all technical personnel, including contracted personnel. This information shall be readily available and shall include the date on which authorization and/or competence is confirmed. The laboratory shall maintain records of relevant authorizations, competence, educational and professional qualifications, training, skills, and experience of all technical personnel, including contracted personnel. This information shall be readily available and shall include the date on which authorization and/or competence is confirmed.Standard Section 6.1.2 EN/ISO 10012:2003 Section 6.1.2 EN/ISO 10012:2003 Records of training activities are maintained. Records of training activities are maintained.Standard Section 6.2.2 ISO/FDIS 13485:2003 (E) Section 6.2.2 ISO/FDIS 13485:2003 (E) Maintain appropriate records of education, training, skills and experience. Maintain appropriate records of education, training, skills and experience.

31. Training Records Requirement Training records which include the following: Training matrix of authorizations Training matrix of authorizations Training effectiveness Training effectiveness Training goals procedure and record Training goals procedure and record Competency/qualification records for education, training, skills and experience. Competency/qualification records for education, training, skills and experience.

32. Training Record