American Association for Laboratory Accreditation

Transcription

1 Page 1 of 35 The following pages present the Forensic Examination Accreditation specific requirements. The policies, procedures and activities of organizations performing forensic testing must meet these requirements. Management system documentation and supporting records must be available for the assessor s review. s (clauses) that include the need for a written policy, procedure or arrangement have a thick, black border. Laboratory Instructions: This checklist must be completed and submitted as part of the application for accreditation in order to help both the laboratory and assessor(s) prepare for the assessment. Correct completion of this checklist may save a significant amount of assessment time and cost. Complete the document reference identifiers in the checklist's second column (labeled "") for all requirements within a thick, black border. The appropriate reference must identify the document (quality manual, laboratory manual, SOPs, etc) and include a locator to facilitate identification of the appropriate portion(s) of the relevant document (page number, section number, etc.) The management system documentation and supporting records must be available for the assessor's review. A2LA Assessor Instructions: Review the laboratory s documented management system to verify compliance with the applicable requirements. Assess to verify that the documented management system is indeed implemented as described. Place a tick mark in the yes (Y), no (N), or not applicable (NA) space for each checklist item. Please note that for all N/A indications, you must document the reason why this requirement is N/A in the comments section. Record comments related to any requirement in the space provided. Record comments related to tests on separate sheets and/or on the Test Method Matrix. All deficiencies must be identified and explained in the assessor deficiency report. Assess the laboratory s technical competence to perform specific tests or specific types of tests. Please also complete the separate C104 General Checklist: s When Making to A2LA Accredited Status, C113 Specific Checklist: A2LA Policy on Measurement Traceability for Life Sciences Testing and Forensic Conformity Assessment Bodies (CABs), and C106 General Checklist: Proficiency Testing for ISO/IEC Laboratories checklists. The laboratories themselves are not required to complete C104, C106, and C113 prior to the assessment. IMPORTANT NOTE: An asterisk (*) in the comments section indicates that the assessor must document the specific traceable objective evidence reviewed in association with that requirement. Objective evidence information is mandatory for those clauses by A2LA. All rights reserved. No part of this document may be reproduced in any form or by any means without the prior written permission of A2LA.

2 Page 2 of 35 To the best of my knowledge, all organization document references below as well as actual practice, have been assessed for compliance to the relevant clauses of this document. I hereby attest that all Yes marked compliance clauses, whether initialed or not, meet the aforementioned requirements. Any areas of noncompliance have been fully described in the Assessor Deficiency Report. CAB Name: Address: Contact: Phone: Master Code: Certificate(s): Assessment Dates: Assessor(s): Assessment ID: Conformity Standard: Assessment Type: Assessor Signature(s): AcO:

3 Page 3 of Management s 4.1 Organization 4.1 F1.1 The management system requirements of ISO/IEC and the additional requirements of this document apply to the organization s permanent facilities and examinations performed at onand off-site locations. 4.1 F1.2 The forensic organization, when applicable, shall: a. Have a policy and procedure for maintaining adequate security for personnel and operations. 4.2 Quality Management System 4.2 F1.1 The organization shall have a technical manager(s), however named, who is responsible for:

4 Page 4 of 35 a. Overseeing the technical operations of the organization; b. Initiating, suspending and authorizing the resumption of work; c. Overseeing the validation and approval of all methods used by the organization and to propose new or modified procedures; d. Overseeing staff training and continuing education; e. Authorizing technical staff to perform particular types of sampling, to perform tests and/or calibrations, to issue reports, to give opinions and interpretations and to operate particular types of equipment. 4.3 Document Control 4.3 F1.1 The organization shall have and maintain or have access to the following items to be used for research, education, identification, comparison or interpretation purposes. (See section 5.6 F1.4): *

5 Page 5 of 35 a. documents (i.e. text books, scientific journals); and b. A Collection of forensic items of known origin, when applicable. 4.4 Review of requests, tenders and contracts No additional requirements. 4.5 Subcontracting of tests and calibrations 4.5 F1.1 When an organization subcontracts work, the work shall be placed with a competent subcontractor. Competency shall be clearly defined and may include: to regulatory requirements for the discipline in which examination is sought; to ISO/IEC specific to the subcontracted activities being sought; and to this requirements document.

6 Page 6 of F1.2 Records of actions taken to check compliance shall be maintained. 4.5 F1.3 Result data produced by subcontractors shall undergo technical review and approval prior to release to customers. (See section 4.13 F1.10) 4.6 Purchasing services and supplies No additional requirements. 4.7 Service to the customer No additional requirements. 4.8 Complaints No additional requirements. 4.9 Control of nonconforming testing and/or calibration work No additional requirements Improvement No additional requirements Corrective action No additional requirements. *

7 Page 7 of Preventive action No additional requirements Control of Records 4.13 F1.1 The forensic science organization shall have documented procedures to ensure that it maintains a coordinated record relating to each case under investigation. The information that is to be included in case records shall be documented. Such a list may include, but is not limited to: Case Identifier; Records of requests, tenders or contracts; List of all items submitted and date of submission; Evidence receipts; Chain of Custody records for each item of evidence; Descriptions of items and examinations performed; Examination results and reports; *

8 Page 8 of 35 to procedures used; and Diagrams, print-outs, auto radiographs, photographs, etc F1.2 The forensic organization shall have written procedures for the documentation and maintenance of case notes F1.3 The records required to support conclusions shall contain sufficient information to enable another competent analyst/examiner to evaluate what had been performed and interpret the data F1.4 Where instrumental analyses are conducted, operating parameters shall be recorded or have traceability through the records F1.5 When a test result or observation is rejected, the analyst shall document the reason(s) for rejection in the case record.

9 Page 9 of F1.6 All examination records shall be paginated using a page numbering system that indicates the total number of pages and end of record F1.7 Each page within the case record shall be traceable to the analyst/examiner and where appropriate, to a uniquely identified case or exhibit. It shall be clear from the case record who has performed each stage of the analysis/examination and when each stage of the analysis/examination was performed (e.g. relevant date(s)) Internal audits No additional requirements Management reviews No additional requirements. 5.0 Technical s 5.1 General No additional requirements.

10 Page 10 of Personnel 5.2 F1.1 The forensic science organization shall have a defined policy and procedure that ensures that all staff working in the organization are competent to perform the work required. The term competent implies possessing the requisite knowledge, skills and abilities to perform the job duties, demonstrated acceptable performance of testing duties and ongoing maintenance of skills and expertise through continuing education. The organization s policy and procedure shall include the requirements for professional certification, training and retraining, a period of supervised casework and maintenance of skills and expertise through continuing education.

11 Page 11 of 35 Where test, examination or technique specific training is given, acceptance criteria shall be assigned. Where necessary, training programs shall also include training in the presentation of evidence in court. 5.2 F1.2 Professional Certification 1 All * examiners/analysts shall maintain or be in the process of obtaining certification in the primary discipline in which they are approved to perform testing, where available and applicable. (e.g. ABC, BDFE, IAI, IACIS, IAAI) Note: In process may include a documented plan with progress milestones, internal certification program of which the examiner/analyst is taking part, or other evidence of efforts by the examiner/analyst to pursue certificate. Where certification programs require initial competencies/testing in areas of forensic science that the examiner/analyst is not approved/trained, certification in that program is not be required. 5.2 F1.3 The organization shall have clear statements of the competencies required for all job descriptions. 1 Professional Certification means: The process by which a forensic practitioner is recognized for meeting the qualifications necessary to practice in a forensic discipline(s).

12 Page 12 of F1.4 The organization shall maintain records to demonstrate the competency of staff for all job duties that they are authorized to perform. Records shall be sufficiently detailed to provide evidence that staff performing particular tasks have been properly trained and that their subsequent ability to perform these tasks has been formally assessed. 5.2 F1.5 The organization shall have a documented training program and maintain an up-to-date record of the training that each member of staff has received. These records shall include academic and professional qualifications, external or internal courses attended, and relevant training (and retraining, where necessary) received whilst working for the organization. These records shall include: a. Title of class or program; b. Brief description of teaching points; c. Date completed; * *

13 Page 13 of 35 d. Name and qualifications of presenter; and e. Record of Performance (if applicable). It is recognized that there may be instances where all of the above information may not be available (e.g. online courses, courses at tradeshows). Where a portion of the above required information is unavailable, this shall be indicated in the record. 5.2 F1.6 Technical personnel, regardless of previous experience, shall complete a qualifying test or tests in all areas for which they have been deemed competent before being approved for casework. Records of acceptable performance shall be maintained. 5.2 F1.7 The organization shall, at a minimum annually assess the competence of all staff to perform testing in the disciplines in which they have been authorized. 5.2 F1.8 Educational s *

14 Page 14 of 35 The forensic organization shall set minimum education and experience requirements for managerial, technical and key support personnel involved in tests and/or calibrations. Consideration should be given to each forensic discipline and related published guidelines when determining degree or subject matter requirements. Technical staff who were previously authorized by management to perform examinations, but do not meet current educational requirements may be authorized to perform such functions at the discretion of the organization if the staff member's experience exceeds that of the minimum needed to be considered competent. Evidence of prior authorization must be available. Note: Educational requirements included within a given test method or federal or state requirement shall be met by all technical staff for which they apply. (e.g. FBI QAS requirements for DNA examiners) 5.3 Accommodation and Environmental Conditions

15 Page 15 of F1.1 Special care is needed in forensic organizations involved in the analysis or determination of trace levels of materials, including DNA. Physical separation of work that has a high sensitivity to crosscontamination and work that has a low sensitivity to cross-contamination is required. Where special areas are set aside for this type of work, access to these areas shall be restricted and the work undertaken carefully controlled. Appropriate records shall be maintained to demonstrate this control. It may also be necessary to carry out environmental monitoring of equipment, work areas, clothing and consumables. 5.3 F1.2 Access to the operational area of the organization shall be controlled and limited. Visitors shall not have unrestricted access to the operational areas of the facility. A record shall be retained of all visitors to the operational areas of the organization. * *

16 Page 16 of F1.3 Evidence storage areas shall be secure to prevent theft or tampering and there shall be limited, controlled access. The storage conditions shall be such as to prevent loss, deterioration and contamination and to maintain the integrity and identity of the evidence. Appropriate storage conditions shall be used both before and after examinations are performed. 5.3 F1.4 Procedures to prevent crosscontamination, exposure to biohazardous materials and loss of evidence shall be established. 5.4 Methods and Method Validation 5.4 F1.1 All methods shall be fully documented including procedures for quality control, the use of reference materials, where appropriate, and guidelines for the interpretation and reporting of results.

17 Page 17 of F1.2 Technical procedures developed by a forensic science organization shall be validated before being used on casework. A written procedure for the validation of test methods and test procedures shall be followed. Methods may be validated by comparison with other established methods using certified reference materials (where available) or materials of known characteristics. In validating test methods, the following issues (among others) may need to be determined, as appropriate: Sensitivity Specificity Limit of detection Accuracy Precision Reliability Reproducibility Measurement Uncertainty

18 Page 18 of F1.3 Technical procedures used by the organization shall be verified. Verification shall include the following steps: a. Demonstrate the reliability of the procedure in-house against any documented performance characteristics of that procedure; and b. Confirm staff competency to perform the procedure. 5.4 F1.4 Records of method validation and performance verification shall be maintained for future reference and shall contain sufficient information to facilitate, if possible, identification of factors affecting the uncertainty and to enable the test or calibration to be repeated under conditions as close as possible to the original. *

19 Page 19 of F1.5 Forensic science organizations shall have a procedure to identify infrequently performed tests or analyses. For these tests or analyses there are two methods of demonstrating competence, either of which would be equally valid. These are: a. Regular analysis of control samples and use of control charts even when casework samples are not being analyzed; or b. Reverification. Reverification is the analysis of an appropriate reference material before the test or analysis in question is performed on a casework sample. Note: The forensic organization is to define infrequent use as it applied to their methodology. 5.4 F1.6 Calculations and data transfers that do not form part of a validated electronic process shall be checked, preferably by a second, qualified person. The case record shall include an indication that such checks have been carried out and by whom.

20 Page 20 of Equipment No additional requirements. 5.6 Measurement Traceability 5.6 F1.1 The forensic organization shall meet the requirements of A2LA document P113 A2LA Policy on Measurement Traceability for Life Sciences Testing and Forensic Conformity Assessment Bodies (CABs) (and P102a Policy on Material Traceability for Life Sciences Testing Laboratories (where applicable)) for all calibrations and verifications of measurement and test equipment and reference standards. 5.6 F1.2 The quality of reference materials and reagents shall be adequate for the procedure used. The laboratory shall inspect or otherwise verify that the materials or reagents are adequate. Lot/batch numbers of reference materials and critical reagents shall be recorded. *

21 Page 21 of 35 Standard materials and reagents shall be labeled with: a. name; b. concentration, where appropriate; c. preparation date and/or expiration date; d. identity of preparer; e. storage conditions, if relevant; and f. hazard warning, where necessary. When the storage conditions and/or hazard warning, where relevant and necessary, is included in the test procedure or other documents, they would not need to be included on the label.

22 Page 22 of F1.3 Collections of reference data or items/materials encountered in casework that are maintained for identification, comparison or interpretation purposes (e.g. mass spectra, motor vehicle paints or headlamp lenses, drug samples, typewriter print styles, wood fragments, bullets, cartridges, DNA profiles, frequency databases) shall be documented, uniquely identified and properly controlled. 5.7 Sampling 5.7 F1.1 Organizations shall ensure that there are documented procedures and training programs to cover selection, recovery, prioritization and sampling of materials from physical evidence and that detailed competency and training records are kept for all staff involved. 5.8 Handling of Test and Calibration Items *

23 Page 23 of F1.1 For legal purposes, forensic science organizations shall be able to demonstrate that the items examined and reported on were those collected by or submitted to the organization. Chain of custody records that detail each person who takes possession of an item/exhibit shall be maintained from the receipt of the items/exhibits and the date/time of each transfer through processing to storage and where applicable to return to submitting client, or disposal. 5.8 F1.2 The forensic organization shall have documented procedures that describe, where applicable, the collection, packaging, transportation, handling and disposition of collected or submitted items and the measures to be taken to prevent loss, deterioration, contamination and cross contamination and to secure exhibits which must be left unattended. Where possible, sampled items should be preserved for potential reanalysis. *

24 Page 24 of F1.3 Where it is possible to record or copy an item or significant features on an item of evidence (e.g. photographs, tape lifts, casts), the laboratory shall clearly define what is considered evidence and what is considered documentation. 5.9 Assuring the Quality of Testing and Calibration Results 5.9 F1.1 An effective means for a forensic science organization to monitor its performance, both against its own requirements and against the performance of peer forensic organizations, is to take part in proficiency testing programs. When participating in proficiency testing programs, the organization s test procedures shall be used. Performance in the programs shall be reviewed and corrective action shall be taken when results are outside the acceptable limits. Proficiency testing records shall include: *

25 Page 25 of 35 a. Full details of the analyses/examinations undertaken and the results and conclusions obtained; b. An indication that performance has been reviewed and the outcome of that review; and c. Details of the corrective action undertaken, where necessary. 5.9 F1.2 The organization shall meet the requirements of R103 - General s- Proficiency Testing for ISO-IEC Laboratories where relevant and available commercially available proficiency testing and well-organized inter-laboratory comparison programs are available. Where relevant and available programs are unavailable, the laboratory shall perform internal performancebased checks meeting the requirements of ISO/IEC 17025, clause F1.3 The laboratory shall ensure that all staff authorized to perform testing:

26 Page 26 of 35 a. Participate in a commercially available proficiency testing or well-organized inter-laboratory comparison program annually for each discipline in which they are authorized, where the PT/ILC is relevant and suitable to the testing performed; or b. Participate in internally developed proficiency testing, intra-laboratory or inter-laboratory, or round robin testing annually for each discipline in which they are competent; or c. Participate in internal performancebased checks meeting the requirements of ISO/IEC 17025, clause 5.9.1when relevant and available PT/ILC programs are unavailable.

27 Page 27 of 35 In instances where normal testing is performed as a team, with each member performs a step of the test process, the above requirements may be met as a team. Such activities shall be clearly documented. 5.9 F1.4 The laboratory shall have a defined procedure to ensure that personnel participating in the same round of commercial proficiency testing, intra-laboratory or interlaboratory or round robin testing do not share or compare results prior to reporting, except where testing is performed as a team (see 5.9 F1.3) 5.9 F1.5 The organization shall have documented policies and procedures for the administrative and technical review of case records, including test reports.

28 Page 28 of 35 a. Each case file and final report shall undergo administrative review for completeness and accuracy, in relation to case information and required elements of the case file, and shall be conducted and documented in accordance with written procedures. *

29 Page 29 of 35 b. The technical review of case records shall be performed each year at a frequency sufficient to ensure the continued reliability of test results and test conclusions. Technical reviews shall be conducted in accordance with a predetermined schedule. Each technical review shall be carried out by personnel who were not involved in the testing performed and who are competent to perform the examinations being reviewed. Technical reviews shall be documented and shall include an indication that all associated test/examination results have been reviewed, by whom the review was performed and the technical findings of the review. *

30 Page 30 of 35 c. Where administrative or technical review results in incongruent results, opinions or interpretations between technical staff and the reviewer, further investigation following written procedures for the investigation and corrective action, where applicable, of nonconforming results shall be applied. A record of each determination and resolution shall be kept within the case file. 5.9 F1.6 The organization shall have and follow a documented procedure whereby the testimony of each examiner is monitored. Monitoring shall be performed at a minimum annually. The procedure shall also address alternate methods of evaluation when an examiner is not called to give testimony in a given year. *

31 Page 31 of F1.7 The monitoring of testimony shall be documented and shall include appearance, performance and effectiveness of presentation. The laboratory s corrective action procedures shall be followed whenever less than satisfactory results are obtained Reporting the Results 5.10 F1.1 It is accepted that forensic testing organizations may not be able to include all of the items in Court Statements that are detailed in sub-clause 5.10 of ISO/IEC as the format of these documents is prescribed in legislation. Forensic testing laboratories may therefore elect to adopt one or more of the following means of meeting these requirements: The preparation of a test report that includes all of the information required by ISO/IEC 17025; *

32 Page 32 of 35 The preparation of an annex to the Court Statement that includes any additional information required by ISO/IEC 17025; Ensuring that the case record relating to a specific investigation contains all the relevant information required by ISO/IEC F1.2 Reports produced by the forensic organization shall be dated and shall include a description of all evidence or items of evidence collected by or submitted to the organization. This requirement can be addressed through a single report or a combination of reports F1.3 Reports produced by the forensic organization containing quantitative data and/or conclusions, shall include a description of the error rate, measurement uncertainty or uncertainty of the determination where available and in accordance with written guidelines.

33 Page 33 of 35 When reporting quantitative values of a critical nature (e.g. quantitative values where the calculated measurement uncertainty assists the reader in determining whether the reported value falls above or below a legal limit), the calculated measurement uncertainty shall be included on the test/inspection report. When reporting quantitative values that are not of a critical nature (e.g. room measurements or item dimensions), a statement of relative uncertainty or error may be reported on the test/inspection report in lieu of the calculated measurement uncertainty. For example, the room was approximately 10 feet in length F1.4 Case records and reports shall be released to requesting persons, agencies and organization in accordance with federal and state law and following a written policy and procedure.

34 Page 34 of 35 Document Revision History Date Description 10/14/ Document identification number (C223) changed to C221 for consistency with the associated requirement document (R221). - Removed references to P102/C105 and replaced with P113/C113. (Traceability policy). - Assessor instructions updated to include the revised title of the C104 checklist. - Section 4.1 F1.2 (a): Removed requirements for procedures to address health and safety. - Section 4.2 F1.2: Removed requirement for a health and safety manager. - Section 4.13 F1.1: Revised and may include to such a list may include, but is not limited to. - Section 4.13 F1.4: Revised to include or have traceability through the records. - Removed section 4.13 F1.5 as this requirement is addressed in ISO/IEC (this was a requirement to preserve observations and test results where appropriate). - Section 5.2 F1.1: to Personal Certification revised to Professional Certification for clarity. - Section 5.2 F1.2: revised to require certification in the primary discipline in which a technician is approved rather than all disciplines. Also added example providers of professional certification and a note of clarification. - Added sections 5.2 F1.3, F1.4, and F1.5 (was previously section 5.2 F1.4). - Section 5.2 F1.5: Added a clarifying statement for when a training class is taken, but not all of the required information is captured. - Revised section 5.3 F1.6 to 5.3 F1.5 (section F1.5 revised to F1.6). - Revised Section 5.2 F1.7.1, is now a note. - Removed section 5.2 F1.7.2 (education and training requirements in forensic biology). - Section 5.4 F1.2: Revised to refer to test procedures developed by the CAB (previously referred to all technical procedures). - Section 5.4 F1.2: Bulleted list updated. - Section 5.4 F1.3: Revised to clarify that all technical procedures are to be verified before use. - Added section 5.4 F1.4 (was previously section 5.4 F1.3). - Revised section 5.4 F1.4 to 5.4 F Section 5.4 F1.5: (1) Subpart b: Reverification clarified and (2) note added

35 Page 35 of 35 Date Description - Revised section 5.4 F1.5 to 5.4 F Removed sections 5.5 F1.1, 5.6 F1.2, 5.6 F1.3 (these sections are addressed in ISO/IEC 17025). - Section 5.6 F1.4: (1) standard materials revised to reference materials, (2) requirement added to inspect or verify materials/reagents (previously only applied to critical reagents), (3) Third bullet point revised from preparation date, if applicable, and expiration date to preparation date and/or expiration date, and (4) added exception in instances where warnings are documented elsewhere in the laboratory. - Section 5.7 F1.1: (1) Removed introductory sentence and (2) clarified requirement for a procedure(s) that cover selection, recovery, prioritization, and sampling of materials from physical evidence. - Section 5.8 F1.1: section revised to take into account what aspects of chain of custody the CAB is responsible for. - Removed section 5.9 F1.1 (The requirement for QC is already address in ISO/IEC 17025). - Section 5.9 F1.2: (1) Revised to 5.9 F1.1 and (2) revised requirement to clarify that corrective action is required when QC results fall outside acceptable limits. - Section 5.9 F1.2: Section split into two sections: 5.9 F1.2 and F Section 5.9 F.3: Section revised to clarify that PT is required of staff authorized to perform testing and added sub-sections a-c. - Section 5.9 F1.4: Added exception for cases when the CAB uses a team approach to perform testing. - Section 5.9 F1.5: Section split into 3 subsections (a-c). - Section 5.9 F1.5.b: Revised to clarify that technical reviews are to be performed annually. - Section 5.9 F1.6: Section was split into two sections to separate requirements for procedures and records. s for records moved to section 5.9 F1.7, - Section 5.10 F1.2: Revised to clarify that a single report or multiple reports are acceptable to satisfy this requirement. - Section 5.10 F1.3: Revised to clarify that the requirement only applies to repots containing quantitative results or conclusions. - Removed sections 5.10 F1.4, 5.10 F1.5.