6.1 General
6.2 Case Records
6.3 Computers
a. The requirements of the accreditation criteria are met
b. Computer software is documented in sufficient detail and
validated or otherwise checked as being adequate for use.
c. The computer is appropriately maintained to ensure proper
functioning.
d. Appropriate procedures are documented and implemented to
maintain the integrity and the security of the data including the prevention of unauthorized access to and amendments of computer records.
The forensic science laboratory shall establish a system that will
ensure that all records required by its quality system are
the accreditation criteria include case records, management review
records,complaints, staff training records,quality assurance records
(including qualitycontrol,proficiency testing,court testimony
monitoring, corrective action, equipment maintenance and
calibration records). The laboratory must document its policies for
the identification, collection, access, storage, maintenance and
disposal of records, whatever be their type and format. All records
shall be legible and shall be stored and retained in such a way that
they are readily retrievable in facilities that provide a suitable
environment to prevent damage, deterioration or loss. All records
must be accompanied by the identity of the person making the
record. All observations and calculations shall be made by an
initialed single strike out. Nothing in the handwritten information
is to be obliterated or erased. Corrections to results, data etc. stored
on computer must also be recorded. Retention times must be
established and documented for all records but will not be less than
three years. Central and/ or state legislative/judicial requirements
may necessitate the retention of records for longer periods.
6.2 Case Records
The laboratory must maintain a case record in a designated location under unique case designator, usually a laboratory case number. Administrative and analytical documentation generated by a laboratory on a particular case constitute a case record. The laboratory must have documented policies regarding:
a. Describing its case designator system.
b.Detailing the information that is to be included in a case record.
All data and observations and any other analytical or administrative records which support conclusions must be generated and kept by the laboratory. Examples of administrative records include records of case related conversations, evidence receipts, description of evidence, packaging and seals and other pertinent information. Examples of analytical records include reference to procedure(s) followed, test(s) conducted, standards and controls used, diagrams,
print outs, autoradiographs, photographs, observations and results of examinations. In general, the records required to support conclusions must be such that in the absence of the analysts/ examiners any competent analyst/examiner or supervisor could evaluate what was done and interpret the data.
print outs, autoradiographs, photographs, observations and results of examinations. In general, the records required to support conclusions must be such that in the absence of the analysts/ examiners any competent analyst/examiner or supervisor could evaluate what was done and interpret the data.
Where instrumental analyses are done, operating parameters must be recorded. Instrument charts and graphs on analyses that are batched (eg. Blood alcohol screening) may be more appropriately kept in a central location as specified in the laboratory's procedure manuals. Where appropriate observations or test results must be preserved by photography (eg. electrophoretic runs, physical matches), photocopies may also be suitable (eg. T.L.C. results questioned documents). When a test result or observation is rejected, the reason(s) must be recorded.
Calculations and manual data transfers must be checked, preferably by a second person. The case record must include an indication that such checks have been performed.
The case record must include an indication that such checks have been performed. Each page of every document in the case record must bear the laboratory's unique case identifier and the analyst/examiner's name or initials. Laboratory generated examination records must be paginated using a page numbering system records must be paginated using a page numbering system indicating total number of pages. Since case notes and records of observations are subject to summons and/or scrutiny, they must be of a permanent nature. Handwritten notes and observations must be in ink not in pencil. Pencil (including colour) may, however, be appropriate for diagrams or making tracings. Abbreviations are acceptable only if they are readily comprehensible to a reviewer. It must be clear from case record when the work was performed (eg. Relevant date and where appropriate, time)
6.3 Computers
When computers are used for capturing, processing, manipulation, recording, reporting, storage or retrieval of test/examination data or other information pertaining to an investigation, the laboratory must ensure that:
a. The requirements of the accreditation criteria are met
b. Computer software is documented in sufficient detail and
validated or otherwise checked as being adequate for use.
c. The computer is appropriately maintained to ensure proper
functioning.
d. Appropriate procedures are documented and implemented to
maintain the integrity and the security of the data including the prevention of unauthorized access to and amendments of computer records.
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