Jun 2, 2018 - ASCLD note: (Ref 5.2.6.1.1, 5.2.6.1.2 and 5.2.6.1.3 except those performing DNA analysis) A qualified individual, whose degree is in some ...
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Michael Tay & Lim Chin Chin Forensic Chemistry & Physics Laboratory, Forensic Science Division, Health Sciences Authority
SUPPLEMENTAL REQUIREMENTS FOR THE ISO17025 ACCREDITATION OF FORENSIC LABORATORIES PART 2
2 June 2010
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Section 5: Technical Requirements
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• 5.1.3 Establish a documented procedure for routinely checking the reliability of its reagents. • 5.1.3.1 Label reagents prepared in the laboratory, at a minimum, with the identity of the reagent and the preparation date or lot number. • ASCLD note: Records shall be maintained identifying who made the reagent and that its reliability was tested and the reagent worked as expected.
5.1 Reliability of reagents
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• 5.2.1: Sufficiently detailed records showing that staff performing particular tasks have been properly trained and that competencies formally assessed. • documented training program encompassing the knowledge, skills, and abilities needed to perform the testing. • procedures for re-training and maintenance of skills and expertise. • ASCLD note: sufficiently comprehensive training program to cover all aspects of the work for each discipline in casework.
5.2 Personnel: Training records
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5.2.1.2 Where applicable, training programs shall also include training in the presentation of evidence in court.
Moot court training
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• 5.2.2 ASCLD note: Policy on employee development should address the various opportunities available to employees, such as: 9 professional organizations and their meetings 9 staff development seminars 9 technical training courses 9 in-house technical meetings, courses, and seminars 9 lab sponsored seminars and conferences 9 college level courses • ASCLD note: The development program should state how employees can participate in it and identify the procedures for applying for such training. • Any special lab criteria for selection of personnel should be stated. It is important that the program demonstrate planning for the development of individual employees, lab sections and the lab as a whole.
Training program
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Toxicology • 5.2.6.1.2 Analysts in the Toxicology discipline shall possess a baccalaureate or an advanced degree in a natural science, toxicology, criminalistics or a closely related field.
Controlled Substances and Trace Evidence • 5.2.6.1.1 Analysts in the Controlled Substances and Trace Evidence disciplines shall possess a baccalaureate or an advanced degree in a natural science, criminalistics or a closely related field.
5.2.6.1 Education
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Biology • 5.2.6.1.3 Analysts in the Biology discipline shall possess a baccalaureate or an advanced degree in a natural science, criminalistics or a closely related field and, if performing DNA analysis and where applicable, shall meet the education requirements of the QA Standards for Forensic DNA Testing Labs and QA Standards for Convicted Offender DNA Databasing Labs. • ASCLD note: (Ref 5.2.6.1.1, 5.2.6.1.2 and 5.2.6.1.3 except those performing DNA analysis) A qualified individual, whose degree is in some other field, but who has taken extensive course work in biology and/or chemistry and has numerous years of experience may meet the educational requirements on a case by case basis as determined by ASCLDLAB-International.
5.2.6.1 Education
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Firearms/Toolmarks, Questioned Documents or Latent Prints • 5.2.6.1.4 Analysts working in the Fireams/Toolmarks, Questioned Documents or Latent Prints disciplines shall meet the educational requirement(s) specified in the job description. • ASCLD note: While not mandatory, the lab should require a baccalaureate degree with two or more science courses for any analyst working in the Firearms/Toolmarks, Questioned Documents or Latent Prints disciplines.
5.2.6.1 Education
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• ASCLD note: While not mandatory, the lab should require a baccalaureate degree with science courses for any analyst working in the Digital Evidence or personnel working in the Crime Scene discipline.
Digital evidence, Crime scene & Technical support • 5.2.6.1.5 Personnel working in the Digital Evidence and Crime Scene disciplines and technicians working as technical support shall meet the educational requirement(s) specified in the job description.
5.2.6.1 Education
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• 5.2.6.2.1 All analysts, regardless of academic qualifications or past work experience, shall satisfactorily complete a competency test before assuming casework responsibility. • ASCLD note: Satisfactorily completing a competency test means achieving the intended results. Failure to achieve the intended results would require review or re-training until testing yields intended results. • ASCLD note: Competency testing should include: evaluation of knowledge of existing literature, written and/or oral examinations, examination and identification of known and unknown material, and moot court.
5.2.6.2 Competency testing
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5.2.6.2.2 Crime Scene personnel, regardless of academic qualifications or past work experience, shall satisfactorily complete a competency test before assuming primary responsibility for the examination, documentation and processing of a crime scene.
Competency of crime scene personnel
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5.2.6.2.3 Technical support personnel, regardless of academic qualifications or past work experience, shall satisfactorily complete a competency test before assuming independent responsibility for any task that could reasonably be expected to affect the outcome of any test or calibration reported by the lab.
Competency of Technical Support personnel
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5.2.6.2.4 All analysts working in any subdiscipline of forensic science shall satisfactorily complete competency testing in each subdiscipline before assuming casework responsibility in a sub-discipline.
Competency in sub-disciplines
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• 5.2.7 The lab shall maintain or provide access to literature resources such as relevant books, journals and other literature dealing with each discipline. • ASCLD note: Location - A forensic library may be located in multiple locations and electronic storage and/or access is permitted as one form of library materials as long as all employees have a reasonable means of access.
Forensic library
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• 5.3.3 Special care is needed in forensic labs involved in the analysis or determination of trace levels of materials, including DNA. • Physical separation of high-level and low-level work 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 kept to demonstrate this control. • May also be necessary to carry out ‘environmental monitoring’ of equipment, work areas, clothing and consumables.
5.3 Accommodation and environmental conditions
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• 5.3.4.1 Written policies or procedures that address lab security to ensure that: a) Access to the operational area of the lab is controllable and limited. Visitors shall not have unrestricted access to the operational areas. b) All exterior entrance/exit points have adequate security control. c) Internal areas requiring limited/controlled access have a lock system. d) Accountability of all keys, magnetic cards, etc., is documented and their distribution limited to individuals designated by the lab director to have access. e) The lab is monitored during vacant hours by an intrusion alarm or by security personnel.
5.3 Accommodation and environmental conditions
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• f) Evidence storage areas: Secured to prevent theft or interference and there is limited, controlled access. • Evidence storage conditions shall prevent loss, deterioration and contamination and maintain the integrity and identity of the evidence before and after examinations. • ASCLD note: Fire safety - Labs should have a fire detection system.
5.3 Accommodation and environmental conditions
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• 5.3.6 The lab shall have, and demonstrate use of a documented health and safety program. • ASCLD note: Use of such a program could be demonstrated by: 9safety training records, 9safety inspections, and 9documentation of preventive action taken by the lab management, or 9action to address safety issues/concerns expressed by lab personnel.
Health and Safety Program
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• 5.4.1.1 All methods shall be documented and the documents readily available for review by lab personnel. • ASCLD note: Considerable variations in case samples require that forensic scientists have the flexibility to exercise discretion in selecting the most appropriate method. • ASCLD note: The lab director needs to ensure that procedures meet acceptable scientific standards (e.g. the use of positive and negative controls). • 5.4.1.2 Appropriate controls and standards shall be specified in the methods and their use documented in the case record.
5.4 Test and calibration methods and method validation
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• 5.4.2a All technical procedures shall be fully validated before use in casework. • 5.4.2b Where a lab introduces a new (validated) method, it shall first demonstrate the reliability of the procedure in-house against any documented performance characteristics of that procedure. • Records of performance verification shall be maintained for future reference.
Method validation
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• 5.4.2c Labs shall institute a procedure to identify infrequently performed tests (analyses). Either of two methods is valid for demonstrating competence: 9 regular analysis of control samples and use of control charts even when ‘real’ samples are not being analyzed; or 9 re-verification before the test is performed on a real sample involving at least the use of an appropriate reference material, followed by replicate testing or analysis of the real sample.
5.4 Infrequently performed tests
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• 5.4.2.1 Before implementing a validated method new to the lab, the reliability of the procedure shall be demonstrated in-house against any documented performance characteristics of that procedure. • Records of performance verification shall be maintained for future reference.
5.4.2 Selection of methods
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5.4.2d The quality of standard materials and reagents shall be adequate for the procedure used. • Lot/batch numbers of standard materials and critical reagents shall be recorded. • All critical reagents shall be tested for their reliability. Standard materials and reagents shall be labelled with: 9 name; 9 concentration, where appropriate; 9 preparation date and or expiry date; 9 identity of preparer; 9 storage conditions, if relevant; 9 hazard warning, where necessary.
Quality of standard materials and reagents
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• 5.4.5.1 All technical procedures must be fully validated before use in casework. • Methods may be validated by comparison with other established methods using CRMs (where available) or materials of known characteristics. • In validating test methods, the following issues may need to be determined, as appropriate: 9 matrix effects interferences 9 sample homogeneity concentration ranges 9 specificity stability of measured compounds 9 linearity range population distribution 9 precision measurement uncertainty.
5.4.5 Validation of methods
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5.4.5.2 ASCLD note: Validation studies can be conducted by: 9the scientific community (eg standard or published methods) or 9by the lab itself (eg methods developed in-house or where significant modifications are made to previously validated methods).
5.4.5 Validation of methods
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5.4.7.2.1 Labs shall implement appropriate measures to prevent unauthorized access to computer systems used for examining digital evidence.
5.4.7 Control of data (digital evidence)
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a) General service equipment not directly used for making measurements, e.g., hot plates, stirrers, nonvolumetric glassware, cameras, refrigerators • Typically maintained by visual examination, safety checks and cleaning as necessary. • Calibrations or performance checks only necessary where the equipment setting can significantly affect the analytical result (e.g., temperature of a muffle furnace or constant temperature bath).
• 5.5.2 All labs are required to operate a program for the maintenance and calibration of equipment.
5.5 Equipment
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b) Microscopes including attachments • Cleaned and serviced periodically. Properly set up for use and are used only by competent staff. Where microscopes are used for measurement the guidance given in paragraph d) applies. c) Volumetric equipment • Typically maintained by visual examination and cleaning but performance checks will need to be carried out before initial use and at intervals depending on the type and frequency of use.
5.5 Equipment
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d) Measuring instruments - thermometers, balances, densitometers, chromatographs, spectrometers and spectrophotometers, refractometers • Correct use combined with periodic servicing, cleaning and calibration will not necessarily ensure that a measuring instrument is performing adequately. Therefore, where appropriate, periodic performance checks shall be carried out and predetermined limits of acceptability shall be assigned. • Frequency of performance checks determined by need, type and previous performance. • Often possible to build performance checks or system suitability checks into test methods (eg, chromatographic systems, measurement of glass RI). These checks shall be documented and shall be satisfactorily completed before the equipment is used or before results are accepted. e) Computers and data processors.
5.5 Equipment
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• 5.6.1.1 Procedures to check calibration of instruments shall be established depending on the specific requirements of the analysis. • Normally necessary to check calibration after any shut down, servicing or substantial maintenance. • Calibration check intervals not less stringent than manufacturers' recommendations. • 5.6.2.2 ASCLD note : For many types of analysis, calibration checks may be carried out using synthetic standards prepared within the lab from chemicals of known purity and composition, or matrix-matched standards. Alternatively, standard solutions may be purchased. Many chemicals can be purchased with the manufacturer's statements or certificates. Wherever possible, labs should purchase chemical standards from IS0-compliant suppliers.
5.6 Measurement traceability
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• 5.6.3.2.1 Reference collections of data or items/materials encountered in casework which are maintained for identification, comparison or interpretation purposes shall be fully documented, uniquely identified and properly controlled. • Examples of reference collections: mass spectra, motor vehicle paints or headlamp lenses, drug samples, typewriter print styles, wood fragments, bullets, cartridges, DNA profiles, frequency databases
5.6.3 Reference standards and reference materials
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• 5.7.1 ASCLD note: The process of sampling submitted evidence is unique for each discipline and, where appropriate, should be documented in the operations and/or analytical procedures of the lab. • Labs should ensure that training programs cover this aspect of their work and that competency/training records are retained.
5.7 Sampling
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• 5.8.1.1 Must be able to demonstrate that the evidence examined and reported on was that submitted to the lab. • Maintain a "chain of custody" record from the time of receipt and reflect all internal transfers. • The record shall detail each person taking possession of an item of evidence, or the location of that item. At a minimum this record shall include: 9 A signature, or equivalent identification, of the person/location receiving evidence 9 The date of receipt or transfer 9 A description, or unique identifier, of the evidence
5.8 Handling of test and calibration items
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• ASCLD note: Key components of an evidence control system are: a documented chain of custody, proper marking of evidence, proper evidence seals, and a secure area for evidence storage. • Electronic tracking of evidence is an acceptable alternative to a written record as long as the computerized data is sufficiently secure, detailed and accessible for review and can be converted to a hard copy when necessary. • Unique personal identifiers, having individual security, are acceptable in lieu of actual signatures.
5.8 Handling of test and calibration items
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5.8.1.1.1 When evidence is subdivided in the lab, subitems shall be tracked through a documented chain of custody record to the same extent that original items of evidence are tracked.
Tracking sub-items
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• 5.8.4.1 Any evidence not in the process of examination that must be placed in a container to protect it from loss, crosstransfer or contamination shall be stored under proper seal. • 5.8.4.2 All evidence not in the process of examination shall be maintained in a secured, limited-access storage area. • ASCLD note: Packaged evidence received by a lab which does not bear the initials or identification of the person sealing the evidence container is not considered to be properly sealed. • ASCLD note: Evidence which is properly sealed and marked for identification may be placed in unsealed, unmarked containers (eg boxes or bags) for the purpose of grouping or carrying items of evidence as long as evidence security requirements are met.
Storage of evidence not in the process of examination
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• 5.8.4.3 Documented procedures which describe the measures taken to secure unattended evidence which is in the process of being examined. • 5.8.4.3.1 Lab policy concerning evidence in the process of examination cannot be open-ended and shall be based upon a justifiable expectation of frequent examination.
Storage of evidence in the process of examination
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• 5.8.4.4 Each item of evidence shall be marked for identification in such a manner as to ensure that it is uniquely identifiable and traceable to the unique case number. • If the evidence does not lend itself to marking, its proximal container or identifying tag shall be marked.
Unique identification of evidence
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5.8.4.5 When evidence, such as latent prints and impressions can only be recorded or collected by photography and the image itself is not recoverable, the photograph or negative of the image shall be treated as evidence.
Latent print and impression evidence
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• 5.8.4.6 Evidence collected from a crime scene by lab personnel shall be protected from loss, cross transfer, contamination and/or deleterious change, whether in a sealed or unsealed container, during transportation to an evidence facility. • Where appropriate, further processing to preserve, evaluate, document, or render evidence safe shall be accomplished prior to final packaging. • Evidence collected from a crime scene shall be appropriately identified, packaged and entered into the evidence control system as soon as practical.
Collection of evidence at a crime scene
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ASCLD note: Individual characteristic database samples include test fired ammunition produced in the lab, known blood or standard biological samples, and the 10-print cards (or their electronic images) of known individuals. 5.8.4.7 Must have procedures for the operation of individual characteristic databases. 5.8.4.7.1 Must establish whether individual characteristic database samples are treated as evidence, reference materials, or examination documentation. 5.8.4.7.1a Individual characteristic database samples treated as evidence shall meet chain of custody (5.8.1.1), evidence sealing and protection (5.8.4.1), evidence storage (5.8.4.2), and evidence marking (5.8.4.4) requirements. 5.8.4.7.1b Individual characteristic database samples not treated as evidence shall meet 5.8.4.7.2 through 5.8.4.7.4.
Individual characteristic databases
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5.8.4.7.2 Each individual characteristic database sample under the control of the lab shall be uniquely identified. 5.8.4.7.3 Individual characteristic database samples shall be protected from loss, cross transfer, contamination and/or deleterious change. ASCLD note: Changes to electronic fingerprint records that are undertaken to improve the quality of information (e.g. "rolled print substitutions", consolidation of records) are not loss or deleterious change events under this standard provided that the lab has procedures for meeting examination documentation requirements for fingerprint records used for identifications (not eliminations) in latent print casework. 5.8.4.7.4 Access to individual characteristic database samples under the control of the lab shall be restricted to persons authorized by the lab director. ASCLD note: Such authorized persons may include computer technicians who are not employees of the lab, but who are responsible for equipment repair, database maintenance, improvement, etc. of a database that is under the control of the lab.
Individual characteristic databases
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5.9 ASCLD note: Analytical performance should be monitored by operating quality control schemes which are appropriate to the type and frequency of testing. Quality control activities includes the use of: • reference collections; certified reference materials and internally generated reference materials; • statistical tables; • positive and negative controls; • replicate testing; alternative methods; • repeat testing; • spiked samples, standard additions and internal standards; • independent checks (verification) by other authorized personnel.
Quality of test results
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• 5.9.3 Must have a documented program of proficiency testing. • 5.9.3.1 the lab's own approved and documented test procedures shall be used in PTs. • ASCLD note: The lab's overall performance in proficiency testing programs should be reviewed regularly and, where necessary, corrective action should be taken. • ASCLD note: PTs should not be subject to policies adopted by the lab for efficiency or expediency of casework. • All parts of a PT test provided by an approved test provider should be examined as completely as the lab's analytical capability allows. • 5.9.3.2 The lab’s PT program shall comply with the ASCLD/LAB Proficiency Review Program.
Proficiency testing
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• 5.9.3.3 Each employee shall successfully complete at least one internal or external proficiency test per calendar year in his/her forensic science discipline(s). • ASCLD note: Successful completion: obtain the correct response or complete appropriate corrective actions. • ASCLD note: The lab should arrange for each employee to annually complete a proficiency test in each subdiscipline in which the employee routinely completes casework.
Frequency of proficiency test
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5.9.3.3.1 Where applicable, DNA analysts and technical support personnel performing DNA analysis shall comply with proficiency test requirements of the Quality Assurance Standards for Forensic DNA Testing Labs and Quality Assurance Standards for Convicted Offender DNA Databasing Labs.
DNA proficiency tests
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• 5.9.3.4 The lab shall participate annually in at least one external proficiency test for each discipline. • Where available, ASCLD/LAB approved test providers shall be used. • Otherwise, the lab shall locate and use a source of an external test in the discipline.
External proficiency tests
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5.9.3.5 Maintain PT records and documentation of a lab's PT program including at a minimum: The test set identifier, How samples were obtained or created, Identity of the person taking the test, Date of analysis and completion, Originals or copies of all data and notes supporting the conclusions (full details of the analyses/examinations undertaken and the results and conclusions obtained), PT results, Any discrepancies noted, An indication that performance has been reviewed and feedback provided to the analyst, Details of the corrective actions taken (when necessary). ASCLD note: Establish criteria for the evaluation of proficiency tests. PT records shall be retained at least 5 years
Proficiency tests records
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• 5.9.4 The lab shall establish a procedure for the technical review of examination documentation and reports. • Ensure that the conclusions of analysts are: 9reasonable, 9within the constraints of validated scientific knowledge, and 9supported by the examination documentation. • Define the scope of the technical review, establish the parameters of the review process, specify how technical reviews are documented, and describe a course of action to be taken if a discrepancy is found.
Technical review
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• ASCLD note: May be carried out on a sample of completed case records. • The lab defines the sampling rate. • 5.9.4.1 Conducted by individuals having expertise gained through training and experience in the discipline being reviewed. • ASCLD note: A technical reviewer need not be an active analyst in the discipline/sub-discipline or currently being proficiency tested in the discipline/subdiscipline. • ASCLD note: Technical reviews do not shift the perceived responsibility for the scientific findings from the analyst to the reviewer.
Technical review
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• 5.9.5 Establish a procedure which requires administrative review of the case file before release of each report. • The lab defines the scope of the review, who may conduct admin reviews, and how the admin review is documented. • ASCLD note: Admin reviews, in whole or in part, may be independent of technical reviews or may be combined as one process.
Administrative review
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• 5.9.6 The lab shall have and follow a documented procedure to monitor annually the testimony of all testifying personnel. • Each individual shall be given feedback and the monitoring procedure shall prescribe the remedial action for unsatisfactory evaluation. • 5.9.7 Records of testimony monitoring retained not less than 5 years.
Monitoring court testimony
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Questions, Answers, Suggestions, Comments…
Thank you!
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