NABL 113 NATIONAL ACCREDITATION NABL BOARD FOR … · nabl national accreditation board for testing and calibration laboratories nabl 113 specific guidelines for accreditation of

NABL

NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES

NABL 113

SPECIFIC GUIDELINES for ACCREDITATION OF

FORENSIC SCIENCE LABORATORIES

AND CHECKLIST FOR ASSESSORS ISSUE NO : 02 AMENDMENT NO : 00 ISSUE DATE: 28.03.2008 AMENDMENT DATE: --

National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 113 Specific Guidelines for Accreditation of Forensic Science Laboratories and Checklist for Assessors Issue No: 02 Issue Date: 28.03.2008 Amend No: 00 Amend Date: -- Page No: i

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National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 113 Specific Guidelines for Accreditation of Forensic Science Laboratories and Checklist for Assessors Issue No: 02 Issue Date: 28.03.2008 Amend No: 00 Amend Date: -- Page No: ii

Contents S.No. SECTION PAGE NO. Section I Guidelines for Forensic Science Laboratory Assessment 1 – 39

1 Introduction 1

2 Scope of Accreditation 2

3 Quality Policy Statement 3

4 Organization and Management 4

5 Quality Management System 8

6 Records 10

7 Personnel 12

8 Training and Development 17

9 Evidence Management 19

10 Methods and Procedures 20

11 Quality Assurance 24

12 Proficiency Testing 25

13 Case Record Review 27

14 Court Testimony Monitoring 28

15 Corrective and Preventive Actions 29

16 Instruments and Equipment 31

17 Calibration 32

18 Reports 33

19 Procurement of Services and Supplies 35

20 Accommodation and Safety 36

21 Subcontracting of Technical Work 41

Section II Checklist for Forensic Science Laboratory Assessment 42 – 56

Section I GUIDELINES FOR FORENSIC SCIENCE LABORATORY ASSESSMENT

National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 113 Specific Guidelines for Accreditation of Forensic Science Laboratories and Checklist for Assessors Issue No: 02 Issue Date: 28.03.2008 Amend No: 00 Amend Date: -- Page No: 1/ 56

1 Introduction

Laboratory Accreditation activities are administered under the direction of the Board for

National Accreditation Board for Testing and Calibration Laboratories (NABL), by involving

Technical Committees and Evaluation Panels as the recommending bodies. NABL system is

based on the ISO/ IEC 17011 for Accreditation Bodies, ISO/ IEC 17025:2005 “General

Requirements for the Competence of Testing and Calibration Laboratories” for laboratories.

The work in Forensic Science Laboratories being interdisciplinary in nature, there is a need to

develop and supplement the “General Criteria for Laboratory Accreditation” for the purpose of

accrediting Forensic Science Laboratories. The document “Specific Criteria for Accreditation

of Forensic Science Laboratories” has been evolved by a Technical Committee specifically

constituted for the purpose. It supplements the document ISO/ IEC 17025:2005 “General

Requirements for the Competence of Testing and Calibration Laboratories” and provides

specific guidance on the accreditation of Forensic Science Laboratories for assessors as well

as the laboratories who are preparing for accreditation. This Specific Criteria is in compliance

with ISO/ IEC 17025:2005.

NABL has adopted the following four objectives which define the purpose and nature of the

programme.

♦ To improve the quality of laboratory services provided to criminal justice system.

♦ To develop and maintain criteria which can be used by a laboratory to assess its level of

performance and to strengthen its operations.

♦ To provide an independent, impartial and objective system by which laboratories can be

benefited through a total operational review.

♦ To offer to the general public and users of the laboratory services a means of identifying

those laboratories which have demonstrated that they meet established standards.

The information contained in this document must be read alongwith the document ISO/ IEC

17025:2005.


2 Scope of Accreditation

Forensic Science refers to examination of crime scene, recovery of evidence, laboratory

examination, interpretation of findings and presentation of the conclusions reached for

investigation and intelligence purpose. This field involves examination of wide range of tems

and substances.

The scope of accreditation of NABL is applicable to the following disciplines/areas of activity in

the Forensic Science Laboratories.

1. Chemistry

2. Toxicology

3. Biology

4. Serology

5. Explosives

6. Physics

7. Ballistics

8. Questioned Documents

9. DNA Finger Printing

10. Forensic Psychology

11. Fingerprints

12. Narcotics

13. Forensic Electronic Investigation

14. Crime Scene Investigation

Accreditation in additional disciplines may be offered in future as per requirement.


3 Quality Policy Statement

The laboratory shall identify the policies and objectives to be achieved by implementing the

management system as per the requirements of ISO / IEC 17025:2005. The objectives shall

be set out in a quality policy statement, issued under the authority of the Director or Chief of

the Laboratory.


4 Organization and Management

4.1 General The forensic science laboratories, or the organization, of which it is a part, shall be legally

identifiable. Where the forensic science laboratory is part of a parent organization, the position

of the forensic science laboratory in the overall organizational structure must be documented,

for example, by use of organizational charts. The forensic science laboratories shall be

organized and be operated in such a way that it meets the accreditation requirements, while

performing work in its permanent, temporary or mobile facilities (including field operations and

regional laboratories). The laboratory shall clearly define and document the type and extent of

the forensic science services it provides. Management must ensure that:

a. the laboratory will not engage in any activities that might diminish trust in its

competence, impartiality, judgement or operational integrity, and

b. the laboratory personnel are free from commercial, financial or any other pressure that

might adversely affect the quality of their work.

4.2 Organizational Structure Taking into account the interrelations of various forensic disciplines the organizational

structure must group the work and personnel in a manner that ensures efficiency of operation.

The laboratory Director must consider and take appropriate action to correct any discrepancies

with regard to numbers of personnel when grouping work and resources. The laboratory shall

normally use only those personnel who are solely employed or under contract in the

laboratory. When other personnel are used, the laboratory shall ensure that all the applicable

accreditation criteria are met with in respect to such personnel. The laboratory must define

and document, in the form of job descriptions and organizational charts, the responsibility,

authority and interrelation of all personnel who manage or perform work affecting the quality of

the forensic science services. The laboratory must have technical management structure

which has overall responsibility for the technical operations and the provision of the resources

needed to ensure the required quality of laboratory operations. The technical management

shall also be responsible for ensuring that the accreditation requirements are met.


A member of the laboratory's managerial staff shall be appointed as the Quality Manager

(howsoever named) who, irrespective of other responsibilities, shall have defined authority for

ensuring that the quality system is established, implemented and maintained, and for reporting

on the performance of the quality system to the management for review, and as a basis for

improvement of the quality system. The Quality Manager should have training in quality

assurance concepts and techniques and ideally should have organizational autonomy from the

technical operations. Where the forensic science laboratory is part of a parent organization, it

may not be necessary for the laboratory to appoint its own Quality Manager. In such cases,

however, a member of the laboratory's staff must be designated as being responsible for

coordinating the maintenance of the quality management system in the laboratory.

The Quality Manager shall have a direct access to the highest level of the management at

which the decisions are taken for the laboratory on policy and resources. The scope of the

responsibilities and the authority must clearly be articulated and should include the following:

• maintenance of the laboratory's Quality Manual,

• monitoring of laboratory practices to verify continuing compliance with policies and

procedures,

• evaluation of instrument calibration and maintenance of records,

• periodic assessment of the adequacy of report review activities,

• ensuring the validation of new technical procedures,

• investigation of technical problems, proposal of remedial actions and verification of

their implementation,

• administration of proficiency testing and evaluation of results,

• selection, training and evaluation of internal auditors,

• scheduling and coordination of quality system audits,

• maintenance of training records of laboratory personnel,

• training recommendations to improve the quality of laboratory staff,

• proposal of corrections and improvements to the quality system.

Wherever possible, deputies must be appointed for key personnel. This must include the

laboratory Director, Quality Manager and Reporting Officers.


4.3 Delegation of Authority The laboratory Director's authority must be well defined. The laboratory Director must have

authority commensurate with his/her responsibilities. There must be sufficient delegation of

authority to managerial/supervisory staff, commensurate with their responsibilities. Each

subordinate must be accountable to only one immediate supervisor per function. Performance

expectations must be well established and fully understood by the laboratory personnel.

In every organization, someone must be assigned the responsibility for the efficient and

effective performance of specific functions. It is important that the persons assigned such

responsibilities also be delegated with appropriate and well defined authority to act or direct

the actions of others.

Effective organization is precluded unless the Director has the authority to accomplish the

mission of the laboratory. As managerial responsibilities increase in scope and complexity,

delegation of authority down the organization becomes necessary. A laboratory must have a

structure that ensures maximum use of the knowledge and capabilities of its staff. Authority

delegated to the lowest possible level serves to achieve this goal. It is important, however,

that all staff clearly understand what is expected of them.

4.4 Supervision There must be constructive discussion between supervisors and subordinates. Supervisors

must carefully and objectively review the laboratory activities, methods and personnel. Clearly

documented and well understood procedures should exist for personnel evaluations.

Supervisory techniques must encourage creative thinking and recognize meritorious

performance.

4.5 Communication Clear vertical, horizontal and diagonal channels of communications must exist within and

outside the laboratory. Vertical channels of communication should normally be used for

administrative functions. Documented procedures should exist for the following:

a. duty hours,

b. leave time,

c. employees' grievances


Staff meetings must be conducted on a routine basis. Good communication is essential for

effective operation. Channels of communication within the laboratory should exist for

coordination of case work and to ensure wide dissemination of technical information. All lines

of communication, vertical, horizontal and diagonal, should be present and open in the

organization. The most important tool for maintaining open communication with laboratory

personnel is routine staff meetings.

4.6 Administrative Practices A formal written budget must exist for the laboratory. The budget must be adequate to meet

the laboratory's objectives. For example, if the objectives (quality policy statement) describe a

full service laboratory providing timely results, but there is insufficient funding for staff or

essential equipment in one or more of the service areas or if inadequate staffing has resulted

in large back logs and lengthy turn-around time, the budget cannot be considered as adequate

to meet the objectives.

The laboratory must have a management information system which provides information to

assist it in accomplishing its objectives. Reporting officers must have access to all such

information upon which the decisions can be based. Some of the information is most easily

developed by, and derived from, a management information system. A management

information system is a system for the collection, manipulation, storage and retrieval of

information (e.g. productivity, budget tracking) to assist laboratory management to determine

how effectively and efficiently the laboratory is operating and to develop resource

requirements to meet the laboratory's short and long term goals and objectives.

Prior to undertaking new contracts or commencing new forensic services, the laboratory must

ensure that:

a. the client's requirements, including the methods, are adequately defined, documented

and understood; and

b. it has the capability (i.e. physical, intellectual and technical ability and personnel with

appropriate skills and expertise) and resources to meet the client's requirements.

Records of such reviews must be maintained.


5 Quality Management System

5.1 General The forensic science laboratory shall establish, implement and maintain an effective quality

management system appropriate to the type, range and volume of forensic science activities it

undertakes. The quality system shall include policies and procedures addressing all the criteria

detailed in these accreditation requirements.

5.2 Documentation 5.2.1 Quality Manual All elements of the laboratory's quality system shall be documented. This will include all

policies, systems, programme, procedures, instructions etc. where the absence of

documentation would adversely affect the test or examination results. Documentation of the

quality system will be in a Quality Manual with cross-referencing to related operations

documentation, where relevant. The Quality Manual and, where relevant, the associated

operational documentation, shall be kept up-to-date under the authority and responsibility of

the Quality Manager. Documentation of the laboratory's quality system must include, where

appropriate, the protocol(s) permitting departures from the documented policies and

procedures.

Quality system documentation shall be readily available to all the personnel. Forensic science

in administration of Criminal justice requires that intensive measures be undertaken to ensure

the overall quality of scientific findings. To accomplish this, a quality system is required to

provide laboratory management with continuing confidence that results and conclusions are

accurate, impartial and relevant. Forensic science laboratories must, therefore, establish and

maintain a quality system that is appropriate for the range of forensic disciplines as well as the

types and numbers of examinations that are conducted. The success of the quality system

depends on the commitment of the management and active participation of each member of

the laboratory staff. To ensure that everyone fully understands what are the expectations, all

elements of the quality system must be clearly articulated in the Quality Manual.


5.2.2 Document and Information Control The forensic science laboratory shall establish and maintain documented procedures to

control all documents and information that relate to its quality system. (Document is any

medium used to record information or instructions. Documents include manuals, work books,

work sheets, charts, posters, notices, memoranda, drawings, plans software, Standard

Operating Procedures etc. Documents maintained in computerised systems must also be

considered. It may also include documents of external origin such as standards, regulations,

manufacturer's manuals etc). All documents which form part of the quality management system shall be reviewed and

approved for use by the authorised personnel prior to issue. A master list or equivalent

document control procedure identifying the current revision status of documents in the quality

system shall be established and be easily available to preclude the use of obsolete

documents. The procedures shall also ensure that:

• The authorized issues of appropriate documents are available at all locations where

operations essential to the effective functioning of the quality system are performed.

• Documents are periodically reviewed and, where necessary, revised to ensure

continuing suitability and compliance with applicable requirements.

• Obsolete documents are deleted from the master list and promptly removed from all

points of issue or use, or otherwise, assured against unintended use.

• Any obsolete document retained for legal and/or knowledge preservation purposes are

suitably identified.

All documents shall be uniquely identified, such identification to include the date of issue

and/or the revision number, the total number of pages or a mark to signify the end of the

document and the authority for issue. Changes to documents shall be reviewed and approved by the same personnel that performed

the original review and approval, unless specifically decided otherwise. The designated

personnel shall have access to pertinent background information upon which they base their

review and approval. Amendments included in documents shall be clearly marked. If the

laboratory's documentation control system allows for the temporary amendment of documents

by hand, pending their re-issue, the procedures and authorities for such amendments shall be

defined and shall ensure that amendments are initialed and dated. Documents amended by

hand shall be formally re-issued as soon as practicable.


6 Records

6.1 General The forensic science laboratory shall establish a system that will ensure that all records

required by its quality system are maintained. Some examples of records required by the

accreditation criteria include case records, management review records, complaints, staff

training records, quality assurance records (including quality control, 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 and

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. Where instrumental analyses are done, operating parameters must be recorded. Instrument

charts and graphs on analyses that are batched eg. Blood alcohol determination, drug

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.

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 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, and

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.


7 Personnel

Technical Management of Forensic Science laboratories must have relevant scientific

qualifications and appropriate forensic experience.

7.1 Laboratory Director The Laboratory Director is defined as the person with direct operational control of the

laboratory. He/she must have a minimum of M.Sc. degree. However, it is desirable to have

PhD degree and additional qualifications in management and administration with sufficient

experience.

He/she must be knowledgeable of the scientific functions and forensic aspects of the

laboratory's work, preferably through experience as a forensic scientist. Where the forensic

science laboratory is a part of the parent organization, the Laboratory Director does not

necessarily have to be the Director or the parent organization.

7.2 Reporting Officers The reporting officer shall have the qualifications and experience as given below for each sub-

discipline.

a. Physics The minimum qualification for the reporting officer shall be Graduate in Science with physics

as one of the subjects or equivalent from a recognized university with atleast five years

experience in relevant field or postgraduate in physics / specialization in relevant field or

equivalent from a recognized university with atleast two years experience in relevant field.

b. Chemistry and Explosives The minimum qualification for the reporting officer shall be Graduate in Science with chemistry


experience in relevant field or postgraduate in chemistry / specialization in relevant field or



c. Toxicology The minimum qualification for the reporting officer shall be Graduate in Science with chemistry

/ biochemistry as one of the subjects or equivalent from a recognized university with atleast

five years experience in relevant field or postgraduate in chemistry / biochemistry /

specialization in relevant field or equivalent from a recognized university with atleast two years

experience in relevant field.

Toxicologists must be competent to perform qualitative analyses for drugs, metabolites and

other toxic substances in biological materials. They must also be able to make a systematic

search for such substances and apply appropriate extractive and separatory procedures.

d. Biology and Serology The minimum qualification for the reporting officer shall be Graduate in Science with biology


experience in relevant field or postgraduate in any biological science / specialization in

relevant field or equivalent from a recognized university with atleast two years experience in

relevant field.

Serologists must have a knowledge of basic biological sciences and sufficient knowledge of

chemistry to understand the procedures used. They must also have adequate knowledge of

the statistics used in forensic serology.

e. Ballistics The minimum qualification for the reporting officer shall be Graduate in Science with physics


experience in relevant field or postgraduate in physics / specialization in relevant field or


Ballistic Examiners must have adequate knowledge of microscopy, special lighting techniques,

preparation of impressions or casts, techniques of comparative examination and the concept

of individualization. They must also have adequate knowledge of the nomenclature, and

operation of firearms, bullet and cartridge case comparisons, powder and shot patterns,

distance determinations and types of firearm determination from a discharged cartridge case

or bullet.


f. Questioned Documents The minimum qualification for the reporting officer shall be Graduate in Science with physics /

chemistry as one of the subjects or equivalent from a recognized university with atleast five

years experience in relevant field or postgraduate in physics / chemistry / specialization in

relevant field or equivalent from a recognized university with atleast two years experience in

relevant field.

Questioned Document Examiners must have knowledge of the principles of photography,

microscopy, comparative examination and individualization. They must also have adequate

knowledge of writing or printing instruments, ink, paper and copying processes.

g. DNA Finger Printing The minimum qualification for the reporting officer shall be Graduate in biological science /

forensic science with genetics as one of the subjects or equivalent from a recognized

university with atleast five years experience in relevant field or postgraduate in biological

science / forensic science / specialization in genetics or relevant field or equivalent from a

recognized university with atleast two years experience in relevant field.

He/she must have knowledge of scientific literature, procedures and practices relevant to DNA

testing. They must have necessary skills to evaluate and interpret results of those tests. They

must also have an adequate knowledge of population genetics and the statistics used in

forensic DNA examinations.

h. Forensic Psychology The minimum qualification for the reporting officer shall be postgraduate in psychology /

specialization in relevant field or equivalent from a recognized university with atleast two years

experience in relevant field.


i. Fingerprints The minimum qualification for the reporting officer shall be Graduate in Science from a

recognized university with atleast five years experience in relevant field or postgraduate in

science with specialization in relevant field or equivalent from a recognized university with

atleast two years experience in relevant field.

They must have adequate knowledge of comparative examination techniques, methods of

processing, recovering and presentation of latest prints. j. Forensic Electronics The minimum qualification for the reporting officer shall be Graduate in Science with physics /

mathematics / electronics / computer science as one of the subjects or equivalent from a


physics / mathematics / electronics / computer science specialization in relevant field or

degree in engineering / technology in electrical / electronics / computer science or equivalent

from a recognized university with atleast two years experience in relevant field.

They must have knowledge of the principles of digital processing, exihibit handling, software /

hardware analysis, data retrieval etc. k. Crime Scene Investigation

The minimum qualification for the reporting officer shall be Graduate in Science from a


science with specialization in relevant field or equivalent from a recognized university with

atleast two years experience in relevant field.

Crime Scene investigators should possess extensive experience and be trained in the

discipline. They must be competent in the application of principles of crime scene

photographer, scene examination, exhibit handling, safety and must have adequate

knowledge of other discipline. They should be competent to independently perform the

assessment of crime scene.

In addition, every reporting officer must have a good understanding of the principles, uses and

limitations of the instruments and the methods and procedures applied to the tasks performed.


7.3 Supporting Personnel (Non-Testifying Staff) Support personnel must meet the requirements of their job descriptions. The job description

and the duties performed must be in agreement.

New members of staff, independent of previous experience, qualifications, must have

satisfactorily completed laboratory’s training program before being authorized to work

independently.


8 Training and Development

A training programme must be established and documented for each functional area of the

laboratory. The training programme must include:

a. the performance of competency test(s) in all applicable areas and

b. where, relevant, the presentation of evidence in the court Competency testing must include:

a. an evaluation of knowledge of existing literature and

b. the examination and identification of known and unknown materials New members of staff, whatever be their qualifications or previous experience, must have

satisfactorily completed the laboratory's training programme before being authorised to work

independently. Laboratory Director must formally authorise staff to perform work

independently. Training records must be maintained for all personnel. Such records must

include details and dates of:

a. relevant academic qualifications,

b. participation in the laboratory's training programme

c. in-house and external training courses undertaken

d. conferences, seminars, workshops etc. attended Records must be sufficiently detailed to show that staff members have been properly trained,

that their subsequent ability to perform casework has been fully assessed and that they have

been authorised to perform work independently. A laboratory training programme must emphasize and teach the skills and knowledge required

to achieve the optimum standards of competence and good laboratory practice within a

specific area of work. Training must also include a substantial knowledge of forensic science

across its wide spectrum and of criminal and civil laws and procedures. A demonstration of

competence to perform what is expected must be included in the programme. It is

recommended that the laboratory establishes a formal means of recognition of successful

completion of the training such as a certificate, letter or memorandum. The field of forensic

science requires examiners to present and defend their findings in the open court of law.

Because of this unusual requirement, practitioners must develop the technical and personal

skills to perform competently.


Some experience/ training must be received in a forensic science laboratory. Credit for other

experience/ training must be evaluated as appropriate in a particular case. Work experience

and training should be considered with respect to intensity and diversity. Experience/training

outside the forensic science laboratory may be substituted for experience/training in the

forensic science laboratory to the extent that it has been demonstrated to be relevant and

adequate. If there is little diversity in the person's work, correspondingly shorter periods of

training/ experience may be sufficient.

Reporting officers/ analysts must be acquainted with the methods that are generally accepted

in the discipline. All examiners must be able to articulate concepts and provide

opinion/testimony relevant to assigned tasks. Pertinent training must be given to all trainees

prior to appearance as an expert witness in the court. This may include conducting moot

court, actual court observations and provision of appropriate reading material.

The laboratory must have an employee development programme. The library of the laboratory

must contain current books, journals and other literature dealing with each functional area. A

system must exist to encourage each employee to review appropriate new literature. The

laboratory must foster an atmosphere wherein employees are encouraged to improve their

knowledge and skills to grow as individuals and to develop their full potential. The primary

means for accomplishing this is a dynamic employee development programme. It should

address the various opportunities available to employees such as:

• professional organisations and their meetings,

• staff development seminars provided by the government agencies, and technical

training courses conducted by various scientific institutions

• in-house technical meetings, seminars and courses,

• university courses

The developmental programme should state how employees can participate in it and must

detail the procedures to be followed when applying for such training. If the laboratory has any

special criteria for selection of personnel for the programme, they should be stated. It is

important that such a programme demonstrates planning for the development of individual

employee, laboratory sections and the laboratory as a whole. In the absence of a written

programme, a well documented record of provision of time and funding to employees for

training will serve to verify that the laboratory has an employee development programme.


9 Evidence Management

9.1 Evidence Control The forensic science laboratory must have a documented evidence control system. The

control system is effectively designed when it ensures and documents the integrity of physical

evidence. A chain of custody record (eg. Signature, date, time, description of evidence) must

be maintained which provides a comprehensive history of each evidence transfer, over which

the laboratory has control. Each individual item of evidence must be marked with unique case

designator for identification. Should the item not lend itself to marking, its proximal container

must be marked. Labeling on caps/ lids alone is not acceptable because of the risk of wrongly

replacing the lids during batch testing of similar samples. The identification should be retained throughout the life of the item in the laboratory. The

system shall be designed and operated to ensure that items cannot be confused physically or

when referred to in records or other documents. Upon receipt of evidence, any abnormalities

or departures from normal or specified conditions shall be recorded. When there is any doubt

as to the suitability of an item for test or examination or when an item does not conform to the

description provided or the test/examination is not specified in sufficient detail, the client shall

b consulted for further instructions before proceeding with the case. Evidence must be stored

under proper seal, specially designed and used for protecting so that its contents cannot

readily escape or become contaminated and only if entering the container results in obvious

damage/ alteration to the container or its seal. Tape used to seal containers must be initialed

(or otherwise identified) to record the person sealing the evidence. Evidence must be

protected from loss, cross transfer, contamination and/or deleterious change. When

destructive tests are necessary, procedures must ensure that as much material as possible is

retained for re-analysis, if necessary. Procedures for sub-sampling must ensure that sample

integrity is maintained. When items have to be stored under specified environmental

conditions, these conditions shall be maintained, monitored and recorded. A secure area for

overnight and/or long term storage of evidence must be available. Access to evidence storage

areas must be restricted and its access should be limited to the personnel authorised by the

Director.

9.2 Evidence Retention and Disposal The laboratory must establish and document its policy and procedures for the retention and

disposal of exhibits following the completion of examinations and/ or testing.


10 Methods and Procedures

10.1 General Test methods and procedures used must be accepted in the field or supported by data

gathered and recorded in a scientific manner. Since a variety of scientific procedures may

validly be applied to a given problem, standards and criteria for assessing procedures need to

remain flexible. In forensic science, well established procedures are often scattered throughout

peer-reviewed literature as well as in less formal documents obtained from conference

proceedings and in house laboratory manuals. Furthermore, minor modifications to improve

published methods can be implemented by a laboratory as appropriate to a particular need.

The important point is that the procedures used be demonstrably capable of producing valid

results.

Even though a procedure may be widely used, there is often no single document articulating a

professional consensus as to its acceptability. Under these circumstances, it relies on the

technical knowledge of its members, the inspection team and/or a NABL Committee

comprising recognized experts in the field.

The methods must be subjected to a validation study. This may be done internally, externally

and/ or collaboratively. Exchange of blind and reference samples with another competent

laboratory is particularly useful for detecting any internal systematic error. It should be noted

that written documentation for each validation study needs to be maintained for future

reference.

The written technical procedures should include descriptions of sample preparation methods,

controls, standards, and calibration procedures. They should also include a discussion of

precautions, possible sources of error and literature references. Although many acceptable

procedures may exist to perform a particular examination, considerable variations; in case

samples require that forensic scientists have the flexibility to exercise discretion in selecting

the method most appropriate to the problem at hand. The laboratory Director needs to ensure

that the procedures used must meet acceptable scientific standards (e.g. the use of positive

and negative controls). Additionally, standards and reagents used should be of satisfactory

quality, (e.g. labelled of certified purity).


Examiners in serology must have:

a. ccess to well established population data bases on the distribution of all genetic

markers which are typed in the laboratory and should have:

b. access to generate local population data bases on the distribution of all the genetic

markers which are typed in the laboratory. Where sampling is carried out as a part of the test method, documented procedures which

include a sampling plan using appropriate statistical techniques must be used. Accreditation

cannot be granted for tests/examinations that a laboratory has never performed or for which

records of performance are not available. It is accepted, however, that forensic science

laboratories are called upon from time to time to undertake analyses/examinations not covered

by the scope of their accreditation. In such cases a laboratory may choose from the following

options:

a. The laboratory can perform the test/examination and report the result ensuring that no

inference can be drawn that accreditation is held for the service.

b. The laboratory can seek accreditation prior to performing the test/examination and

reporting the results.

c. The laboratory can perform the test/examination and report the result indicating that

accreditation is not held for the service and seek retrospective accreditation for the

test/examination.

Retrospective accreditation can only be granted when a laboratory can demonstrate that all

accreditation requirements (including method validation/verification, equipment calibration,

staff training etc.) were met at the time the test/examination in question was performed.

10.2 Documentation Test methods and related procedures (e.g. sample procurement) must be documented and

readily available to the analysts/examiners. In addition to a description of the steps involved in

the analysis/ examination, documentation of methods and procedures must include, where

appropriate:

a. description of the sample/ item to be tested/ examined.

b. parameters or quantities to be determined.

c. equipment/ instrumentation required.


d. description of sample preparation methods, controls, standards and calibration

procedures.

e. a discussion of precautions, possible sources of error or limitations of the procedure.

f. criteria for the rejection of suspect results.

g. data/ observations to be recorded and method of analysis and presentation.

h. literature references. The availability of documented methods will give the examiner the necessary resource

material to support written conclusions and expert testimony.

Where a test can be performed by more than one method, there must be a documented

criteria for method selection. Where appropriate, the degree of correlation between the

methods must be established and documented. 10.3 Method Validation All technical procedures used by a forensic science laboratory must be fully validated before

using them for casework. (Validation is the developmental process used to acquire the

necessary information to assess the ability of a procedure to obtain a result reliably, to

determine the conditions under which such results can be obtained and to determine the

limitations of the procedure. The validation process identifies critical aspects of a procedure,

which must be carefully controlled and monitored. Validation studies can be conducted by the scientific community (as in the case of standard or

published methods) or by the forensic science laboratory itself (as in the case of methods

developed in-house or where significant modifications are made to previously validated

methods). 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:

• Matrix defects

• Interferences

• Sample homogeneity

• Concentration ranges

• Specificity

• Stability of measured compounds


• Linearity range

• Population distribution

• Precision

Methods developed in-house for both qualitative work must be validated by the laboratory

before use. Where a significant modification is made to a validated method, the modification

must be appropriately validated by the laboratory before the method is used. Records of all in-

house validations must be maintained for future reference.

Where a laboratory introduces a new (validated) method, it must first demonstrate the

reliability of the procedure in-house against any documented performance characteristics of

that procedure. As a minimum, the method must be tested using known samples (e.g.

proficiency test samples, samples form an external agency). It is recommended that the

method also be tested using non-probative samples. Records of performance verification

must be maintained for future reference.

10.4 Reference Materials Reference materials must be traceable to national and international certified standard

reference materials, where possible. Reference materials, certified reference materials and

reference collections must be uniquely identified and full details recorded. Purchase, issue and

use of these materials must be controlled and records must be maintained.

10.5 Standards and Reagents The quality of the standard samples and reagents must be adequate for the procedure used.

Lot/batch numbers of standards and critical reagents must be recorded. All critical reagents must be routinely tested for their reliability. Standards and reagents must

be labelled with:

a name of the reagent and standard,

b concentration, where appropriate,

c preparation date,

d identity of the preparer.

Where necessary, the following must also be included on labels:

a expiry date,

b storage conditions,

c hazard warning.


11 Quality Assurance

11.1 Quality Control Analytical performance must be monitored by using quality control procedures appropriate to

the type and frequency of the testing undertaken. The range of quality control activities

available to laboratories includes the use of:

• Reference collections

• Certified reference materials

• Internally generated reference materials

• Independent checks by other analysts/examiners

• Statistical tables

• Positive and negative controls

• Control charts

• Replicate testing

• Alternative methods

• Spiked samples, standard additions and internal standards

Depending on the particular test/examination, one or more of these examples may be

appropriate. Quality control procedures must be documented. A record must be retained to

show that appropriate quality control measures have been taken, that quality control results

are acceptable or, if not, that remedial action has been taken. Where appropriate, quality

control data must be recorded in such a way that trends in analysis can be readily evaluated.


12 Proficiency Testing

The laboratory must have a documented programme of proficiency testing which measures

the capability of its examiners and the reliability of its analytical results. The documentation of

a laboratory's proficiency testing programme must include how the test samples are

obtained/prepared, who has tested them and in what time frame, which laboratory staff

member directs the programme, how and where the testing information is maintained, what

corrective actions are taken, if required, and who oversees them.

Each laboratory must participate in atleast one proficiency testing / interlaboratory comparison

program per sub-discipline, covering all sub-disciplines over a period of four years. Also, the

laboratory must participate in proficiency testing programmes, which are provided by external

test providers approved by NABL. The laboratory must complete a formal agreement with the

test provider permitting release of the laboratory's test results directly to NABL. Such testing

must be conducted annually in every discipline in which a laboratory seeks or holds

accreditation. In addition to participating in external proficiency testing, a laboratory should

conduct inter-laboratory or intra-laboratory proficiency testing using blind tests prepared

internally or externally and submitted as normal casework evidence or re-examination by

another examiner of evidence on which casework was previously completed or known

samples prepared internally and externally.

When participating in proficiency testing programme, the laboratory's routine test procedures

must be used. Performance in proficiency testing programme must be reviewed by the Quality

Manager and relevant supervisory staff. Wherever, necessary, corrective action must be

taken. Proficiency testing records must include:

• full details of the analyses/examinations undertaken and the results and conclusions

obtained,

• an indication that performance has been reviewed, and

• details of corrective action undertaken, where ever necessary.


Note: A proficiency testing programme is a reliable method of verifying that the laboratory's technical

procedures are valid and that the quality of each examiner's work is being maintained. The

primary focus must be to identify areas where additional training or more rigid quality control

may be of use and to demonstrate the current competence of the laboratory. To derive the

maximum benefit from proficiency testing, the laboratory must emphasis the educational

aspects of the programme and avoid a punitive approach while taking any corrective action.

Proficiency test samples must be representative of the items normally examined in the forensic

laboratory. A proficiency test sample must be apportioned among examiners, provided this

may not alter the character of the testing. It is essential that proficiency tests be properly

designed, appropriately administered and fairly evaluated. The testing procedures must be

well understood by all participants. The proficiency of examiners/reporting officers is tested

only if they complete the testing unaware of the results expected.

For details of approach to proficiency testing, NABL guidelines for proficiency testing based on

ISO/ IEC Guide 43 needs to be referred to.


13 Case Record Review

The laboratory must have documented its policies and procedures for the technical and

administrative reviews of case records. This must include:

• the criteria to be used for each type of review;

• the number/percentage of case reports to be reviewed; and

• the course of action in case any discrepancy is found.

Case records that have been reviewed must bear evidence of the review, for example, by

initials of the reviewer.

13.1 Technical Review Conclusions reported must fall within the range of acceptable opinions of knowledgeable

individuals in the field of forensic science or be supported by sufficient data. The laboratory

must therefore, review a sample of case records to ensure that the conclusions of its

examiners are reasonable and within the constraints of scientific knowledge. Technical

review, often performed by a peer, may be carried out on a sample of completed case records

(for example, 20 per cent or six cases, whichever is fewer per examiner per month). The

sampling rate could vary depending upon the situation (for example, a new examiner may

have 100 per cent of cases reviewed while a very experienced examiner my have only a few

cases reviewed each month). Technical review, while important to the laboratory's quality

assurance programme, must not be carried out to the extent that it shifts the perceived

responsibility for the scientific findings from the examiner to the reviewer keeping in mind that

it is the examiner/reporting officer who presents a sworn testimony to the findings.

13.2 Administrative Review Administrative reviews must be conducted on all or most of the case records to ensure the

completeness and correctness of the reports issued.


14 Court Testimony Monitoring

The laboratory must have and follow a documented procedure whereby the testimony of each

examiner is monitored atleast once in a year. Areas that must be covered in the evaluation

include appearance, poise, performance, effectiveness of presentation. The monitoring

procedure must also prescribe the remedial action that is to be taken should the evaluation be

less than satisfactory. A record must be kept of each evaluation.


15 Corrective and Preventive Actions

15.1 Corrective Action Procedures must be documented for corrective actions to be taken whenever the validity of

results is questioned or departures from quality management system policies and procedures

occur. The procedures shall include an investigation process to determine the root cause of

the problem. Corrective actions taken to eliminate the basic cause of non-conformances and

discrepancies shall be of a degree appropriate to the magnitude of the problem and

commensurate with the risks encountered. The results of the corrective actions must be

monitored to ensure their effectiveness.

When the validity of the results are questioned, for example, through proficiency testing or

quality control results, the procedures (s) involved must be reviewed and, if necessary,

withdrawn from use. The procedures (s) may be reinstated only when exhaustive review and

testing demonstrate that they are not, or no longer, the source of error.

Where the identification of non-conformances or departures casts doubt on the laboratory's

compliance with its own policies and procedures or with the accreditation criteria, it shall be

ensured the relevant areas of activity are promptly audited. Records shall be maintained for

the corrective actions, investigations and analysis. The laboratory must promptly notify the

clients in writing when any event casts doubts on the validity of the results or conclusions

given in forensic report. The results of corrective actions shall be submitted to the

management review. Internal audits, NABL assessments, quality control data, proficiency

testing etc. generate recommendations for corrective actions which must be evaluated,

prioritised, implemented and evaluated for effectiveness. Consequently, the system for

monitoring progress must be comprehensive and adequately cross referenced. The Quality

Manager should coordinate this system.

15.2 Preventive Action All operational procedures shall be systematically reviewed at regular intervals to identify any

potential sources of non-conformances and any opportunities for improvement, either technical

or with the quality management system. Action plans shall be developed, implemented and

monitored to reduce the likelihood of the occurrence of non-conformances and to take

advantage of improvement opportunities. After the implementation of preventive actions, the

laboratory shall monitor the results to establish any reduction in deficiencies or improvements


to operations, thereby establishing the effectiveness of the preventive action. The results of

preventive actions shall be submitted for the management review. Preventive action is a

proactive process to identify improvement opportunities, rather than a reaction to the

identification of problems or complaints.


16 Instruments and Equipment

Where the laboratory needs to use instruments and equipments outside its permanent control,

it must ensure that all relevant accreditation criteria are met.

Each instrument/ equipment shall, when appropriate, be uniquely labelled, marked or

otherwise identified. Each major instrument/ equipment must be recorded in an inventory,

which includes:

• name of the instrument/equipment,

• the manufacturer's name, type, identification and serial number or other unique

identification,

• date received and date placed in service, where appropriate,

• current location, where appropriate,

• condition when received (for example, new, reconditioned), where appropriate.

Instruments/equipment must be maintained in proper working order. Maintenance procedures

must be documented. Records must be kept of all maintenance, servicing and repairs.

Equipment known or suspected to be defective shall be taken out of service and clearly

labelled or marked until it has been repaired and shown by calibration, verification or test, to

perform correctly. Whenever practicable, all equipment under the control of the laboratory and

requiring calibration or verification, shall be labelled, coded or otherwise identified to indicate

the status of the calibration or verification and the date when re-calibration or re-verification is

due. Documented operating instructions (for example, the manufacturer's operating

instructions) must be available for each significant item of equipment.

When, for whatever reason, equipment goes outside the direct control of the laboratory for a

period of time, it shall be ensured that the function and, where necessary, the calibration

status of the equipment are checked and shown to be satisfactory before the equipment is

returned to service. The laboratory shall have procedures for safe handling, transportation,

storage and use of equipment in order to prevent contamination and deterioration. Special

procedures may be necessary for equipment used for testing and related activities performed

outside the permanent laboratory facilities.


17 Calibration

17.1 Calibration - Instruments/ Equipment Instruments/ equipments must be properly calibrated. Where equipment used for tests,

including equipment used for subsidiary measurements, have a significant effect on the

accuracy or validity of the test results, that equipment shall be calibrated or otherwise verified

before being put into service and shall be subjected to a programme of re-calibration and/ or

re-verification.

Note: Laboratories can also refer to other NABL specific criteria to follow the calibration interval (e.g.

NABL 103). These intervals are considered as maxima and can vary depending upon equipment

capability, usage, staff expertise. Thus, it is necessary to make intermediate check of equipments /

instruments.

The programme for the calibration of equipment in forensic science laboratories must ensure

that, where the concept is applicable, all significant measurements are traceable, through

certificates of calibration held by the laboratory, to the national standards of measurements.

Where a laboratory performs in-house calibrations, by means of comparisons between

reference standards and working/measuring instruments, the calibration procedure must be

documented. Calibration records (e.g. calibration certificates, calibration data) must be

maintained. The laboratory must have a mechanism that alerts staff when calibrations and

subsidiary checks fall due and indicates the nature of work required.

17.2 Calibration – Chemical Analysis Quality testing in a testing laboratory, particularly in the case of its assessment, highlights the

need to consider closely the question of the accuracy of its measurements and analytical

results and to ensure that the principles necessary to establish demonstrated accuracy have

not been omitted.

The calibration of the parameters associated with chemical analyses and material tests

deserves particular attention, because major errors can occur by neglecting or ignoring the

basic principles of metrology which also apply to these areas.


18 Reports

The information that must be included in the reports of tests/examinations is detailed below:

a a title (for example, test certificate, test report),

b the name and address of the laboratory and, if different from the address, the location

where tests were performed,

c unique identification of the report (for example, by report number) on each page,

d the date of issue of the report,

e the page number and the total number of pages (that is, page “x” of “y”) on each page,

f the name and address of the client,

g description, unambiguous identification and date of receipt of the item(s) tested or

examined,

h date(s) of performance of the test (s) and or examination (s),

i identification of the test/examination method (s) or procedure (s),

j test/examination result (s),

k reference to sampling procedure (s) used by the laboratory where these are relevant to

the validity or application results,

l reference to other information where this may be relevant to the validity or application

of results,

m the name, title and signature or equivalent identification of the person authorised to

release the report.

It is accepted that forensic science laboratories may not be able to comply with all these

requirements. In such cases, the case record pertaining to a particular investigation must

include this information:

a Where the results of tests not performed by the laboratory are included in reports, the

source of those results must be clearly and unambiguously identified on the report.


b Preliminary or interim reports must be clearly indicated as such. Where preliminary or

interim reports are issued, the following must be recorded in the case record:

• the date and time of issue

• the test/ examination result (s) given,

• the name of the person to whom the result (s) were given

A copy of the report issued for a test/ examination must be retained in conjunction with the

case record. If, after the issue of a report, test data are found to be invalid. The original report

must be withdrawn and, if necessary, replaced by one, which is clearly indicated as being a

replacement report. The laboratory policies and procedures for issuing reports must be

documented. These must include:

a prescribed formats for reports, certificates, witness statements, etc.,

b issue of preliminary or interim reports,

c electronic transmission of reports,

d retention of the reports in the case record,

e report authorization,

f withdrawal of invalid reports.

In case of electronically generated reports, laboratory must have appropriate controls such as

access, storage, and back-up results and appropriate password protection. In case the report

has to be accessed from the website by the customer there must be appropriate control to

ensure that the report is downloaded in protected format.


19 Procurement of Services and Supplies

The laboratory shall use, for services and supplies that affect the quality of its tests and/ or

related activities, only those that can be demonstrated to be of adequate quality.

Where no formal assurance of the quality of external services and supplies is available, the

laboratory must have procedures to ensure that the purchased materials and the services

comply with the specified requirements. Records must be maintained of all suppliers, from

whom support services, equipment or supplies are obtained. Documented procedures must

exist for the purchase, receipt and storage of consumables whose properties could affect the

quality of testing and related activities. Where possible, the laboratory must ensure that

purchased equipments and consumables are not used until they have been inspected,

calibrated or otherwise verified as complying with the laboratory’s requirements.


20 Accommodation and Safety

One key responsibility of the Director of the laboratory is to provide an adequate and safe

working environment. Laboratory facilities should reflect due consideration of space, design,

security, health and safety. If each of these factors is properly planned and set in place, the

laboratory’s mission is enhanced and the responsibility of the Director is met. It is recognised

that laboratories will be required to comply with Government building and safety legislation.

The accreditation criteria shall accommodate the provisions of such legislation.

20.1 Space Each employee must have adequate work space to accomplish assigned tasks. Sufficient

space must be provided for storage of supplies, equipment and tools. Analysts/ examiners

must have space available for writing reports and other official communications. Where

possible, there must be a clear delineation of areas used for the clerical aspects of laboratory

work and the areas used for testing/ examinations. Adequate and appropriate space must be

available for records, reference work and other necessary documents. Sufficient space must

be available for each instrument to facilitate its operation. Accessories should be stored near each instrument to facilitate its use and operation. (Labs. in

which usable space falls below adequate levels may experience health and safety problems,

compromised efficiency, adversely affected morale and productivity and an increased risk of

mishandling and contaminating the evidence. In designing and planning for additional space or

a new facility, future space requirements should also be projected.

20.2 Design The physical design should permit the efficient flow of case exhibits from the time of its

acceptance until its proper disposal. The relative locations of functional areas should facilitate

the use of equipment and instruments. Adequate and proper lighting must be available for

personnel to carry out assigned tasks. Adequate and proper plumbing and wiring must be

available and accessible. The laboratory must have proper ventilation, adequate heating,

cooling and humidity control as per the requirements. Bench and floor surfaces must be

appropriate for the work being performed. The design should maximise laboratory functions

and activities, safeguard the physical evidence, protect the confidential nature of the laboratory

operations and provide a safe and healthy environment. Lack of space and / or fiscal

resources are not acceptable reasons for unacceptable laboratory practices.


20.3 Security Access to the operational area of the laboratory must be controllable and limited. Visitors must

not have unrestricted access to the operational areas of the laboratory. A record must be

retained of all visitors to the operational areas of the laboratory.

Where a laboratory exists within a host agency facility, documented procedures may be

required to permit entry during off-hours for emergencies. Such arrangements are acceptable

if they include, for example, the breaking of a storage seal to access a key, code etc. and

notifying an authorised laboratory person. Each emergency access to the laboratory should be

properly documented.

All exterior entrance/ exit points to the laboratory facility must be controlled in order to prevent

access by unauthorized personnel. All security doors must have keys or other access devices

limited to authorised personnel. The entire exterior perimeter of a forensic science laboratory

must inhibit unauthorized access to the laboratory e.g. suspended ceilings which permit

undetected entry to the laboratory are unacceptable.

Short term and long term evidence storage areas require limited/ controlled access. Internal

areas requiring limited/controlled access must have a lock system. Each access device (keys

etc.) must be accounted for in a register and their distribution limited. The laboratory must be

monitored during vacant hours by an intrusion alarm or by security personnel. The laboratory

must have a fire detection system wherever possible. In keeping with any relevant statutory

requirements appropriate fire extinguishing devices must be available and policies and

procedures of laboratory security must be clearly documented. Laboratory personnel should

be trained in fire fighting.

20.4 Health and Safety Health and safety are everyone’s responsibility and require the commitment of each employee

to be effective. Management’s commitment is essential for long term success of a health and

safety programme. Such a cooperative relationship will safeguard the employees of a

Forensic Science Laboratory as well as address management’s responsibility and liability.

All elements of the laboratory’s health and safety programme must be clearly documented in a

manual, which is readily available to all staff.


Examples of procedures, which must be included, where appropriate, are:

• procedure for handling chemical spills,

• cleaning and disinfecting procedures for biological spills,

• cleaning and decontamination procedures for radioactive spills,

• procedures including follow up procedures such as counselling for dealing with needle-

stick injuries,

• evaluation procedures including a plan of the facility showing the location of safety

equipments and fire extinguishers,

• policy on the use of protective clothing eg. gowns, coats, gloves, goggles etc.,

• policy on eating, drinking, applying cosmetics etc. in the laboratory,

• waste disposal procedures,

• routine cleaning and disinfection procedures for work benches, floors, centrifuges,

refrigerators etc.,

• immunization policy,

• accident reporting protocols,

• special procedures for handling hazardous substances.

Material safety data sheets must be available in conjunction with the safety manual. Work

related ‘Accident Insurance’ coverage for all employees shall be provided by the Management.

An officer must be designated as the Health and Safety Manager. Ideally, the Health and

Safety Manager should have received training in occupational health and safety concepts and

in the relevant legislative requirements. The health and safety programme must be monitored

regularly and audited at least annually to ensure that its requirements are being met.

Records of safety audits must be maintained. The laboratory must encourage the use of

available safety devices required by its health and safety manual. Signs must be present to

identify safety equipment such as fire extinguishers, safety showers, eye wash facilities, spill

kits etc.


Proper equipment and material must be available to handle toxic and carcinogenic biological

and/or other dangerous material spills. Spill kits must be available for acids and solvents.

Appropriate disinfectants must be available (It is recommended that 0.05 per cent sodium

hypochlorite be used for routine disinfection and 0.5 per cent sodium hypochlorite be used for

spills of blood and body fluids). Where appropriate, the laboratory should have safety showers and eye wash equipment of

suitable locations and in good working condition. The operation of safety showers must be

checked regularly. If commercial eye wash preparations are used, it must be ensured that the

solutions are within their expiry dates or if distilled water is used the water must be changed at

least once a week. Sufficient exhaust hoods must be available to maintain a safe work environment. Biology

safety cabinets must be available for handling exhibits, samples etc. where protection of

analysts/examiners from biological hazards is necessary. Fume cabinets must comply with

relevant National/International Standards. Sufficient first aid kits must be available and strategically located. An adequate number of

personnel must be trained in first aid procedures. Appropriate storage must be trained in first

aid procedures. Appropriate storage must be provided for volatile, flammable, explosive and

other hazardous materials. A flammable liquids storage cabinet is required for all but small

volumes. Acids and solvents should not be stored together. It may be necessary to store

some material in locked cabinets/cupboards and magazines. Storage on high shelves is

discouraged. Suitable carriers must be available to carry large bottles. The emergency exits

from the laboratory must provide safe passage in an emergency. Evacuation routes must

always be kept clear. General cleanliness and good house keeping must be apparent.

Foodstuffs must not be kept in laboratory refrigerators/freezers/ovens. Centrifuges used for

the biological material must have sealed buckets or a sealed rotor. There must be a documented ‘waste management programme’, which includes procedures for

the disposal of:

• chemical wastes

• biological wastes

• sharp and broken glass

• uncontaminated waste, for example, paper waste

• radioactive waste


Laboratories are also reminded of the requirements of the Indian Quarantine Laws in relation

to imported biological materials. The following must be in place:

• a record or inventory of imported biological materials, their source and when they were

received by the laboratory,

• a documented policy on the disposal of imported biologicals from the lab.

• staff training covering :

- disposal procedures

- Indian Quarantine Laws Requirements.

A register must be maintained of laboratory accidents, injuries and other incidents and the

follow up action taken. Suitable protective clothing/equipments must be available at all the

times. The nature of these items will be dependent on the work being undertaken and might

include:

• laboratory coats/ gowns

• disposable gloves

• rubber gloves

• heat/ cold resistant gloves

• protective eye wear

• face masks

• plastic/ rubber aprons

• foot wear

When radioactive and X-ray work are performed, detectors must be used regularly to monitor

radiation levels and the wearing of film badges by staff may be necessary. Staff must be

advised of immunization and other appropriate precautionary measures. It is recommended

that relevant records be kept. Appropriate hand washing and hand drying facilities must be

available. Hand basins should not be fitted with domestic taps but with a suitable alternative,

for example, elbow or foot activated devices. The use of communal towels is discouraged.

Single use towels or automatic hand drying devices are preferred. A suitable cleaning agent

must be available. Gas cylinders must be secured. Samples/ specimens/ exhibits referred to

other laboratories must be transported in accordance with the Indian Post or other relevant

requirements.


21 Subcontracting of Technical Work

Any subcontracting/ utilizing the other’s facilities is purely/solely the responsibility of the

Forensic Science Laboratories and they (FSLs) are legally responsible for the test reports.

Subcontracting should be placed with a laboratory complying with ISO/IEC 17025:2005

requirements. A register should be maintained of all such subcontractors and sub-contracted

services.

Section II CHECKLIST FOR ASSESSMENT


22 Checklist for Assessment

1. Laboratory Management and Operation 1.1 Planning 1.1.1 Objectives

Standards and Criteria Requirements*1.1.1.1 Does the laboratory have written down

return objectives

Yes No NA I

1.1.1.2 Does the laboratory staff understand and

support the objectives?

Yes No NA I

1.1.2 Administrative Practices

Standards and Criteria

1.1.2.1 Does the laboratory have a formal written

budget?

Yes No NA I

1.1.2.2 Is the budget adequate to meet the written

objectives?

Yes No NA I

1.1.2.3 Handling and preserving the integrity of

evidence

Yes No NA E

1.1.2.4 Facilities for Laboratory Security Yes No NA E

a. Men

b. Material

c. Information related to case records

and reports

d. Establishment

1.1.2.5 Whether a standard format is available for

preparation and storage of case records

and reports

Yes No NA E

1.1.2.6 Inventory control of capital equipment and

consumables

Yes No NA D


1.1.2.7 Maintenance and calibration of equipment

and consumables

Yes No NA D

1.1.2.8 Duty hours Yes No NA D

1.1.2.9 Leave policy Yes No NA D

1.1.2.10 Job requirements and descriptions Yes No NA I

1.1.2.11 Personnel performance appraisal Yes No NA E

1.1.2.12 Employee grievances Yes No NA E

1.1.2.13 Does the laboratory have a Management Information System?

Yes No NA E

1.2 Organizational Policy 1.2.1 Organizational Structure 1.2.1.1 Does the organizational structure group

the work and personnel in a manner that

allows for efficiency of operation, taking

into account the interrelation of various

forensic disciplines?

Yes No NA D

1.2.1.2 Has the laboratory Director considered and

taken appropriate action to correct any

discrepancies with regard to numbers of

personnel when grouping work and

resources?

Yes No NA D

1.2.2 Delegation of Authority


1.2.2.1 Is the laboratory Director’s authority well

defined

Yes No NA D

1.2.2.2 Whether the administrative / financial

powers are commensurate with the defined

responsibilities of the laboratory Director

Yes No NA D

1.2.2.3 Whether there is sufficient delegation of

authority by the Director within the

Organization

Yes No NA D


1.2.2.4 Is authority of the Supervising Officers

commensurate with their responsibilities?

Yes No NA I

1.2.2.5 Is each subordinate accountable to one

and only one immediate Supervisor per

function?

Yes No NA D

1.2.2.6 Are performance criteria established and

are they understood by laboratory

personnel?

Yes No NA E

1.3 Directing 1.3.1 Supervision


1.3.1.1 Is there constructive discussion between

Supervisors and Subordinates?

Yes No NA D

1.3.1.2 Do Supervisors carefully and objectively

review laboratory activities, methods and

personnel?

Yes No NA D

1.3.1.3 Do the supervisory techniques encourage

creative, objective thinking and recognize

meritorious performance?

Yes No NA D

1.3.2 Communication


1.3.2.1 Do clear vertical, horizontal and diagonal

channels of communication exist within

and without the laboratory?

Yes No NA D

1.3.2.2 Are vertical, channels of communication

used for administrative functions?

Yes No NA D

1.3.2.3 Are staff meetings a routine function Yes No NA D

1.3.3 Training and Development



1.3.3.1 Does the laboratory have and use a

training programme in each functional area

for employees who are new, untrained or

in need of remedial training?

Yes No NA D

1.3.3.2 Does the laboratory have an Human

Resource Development Programme?

Yes No NA D

1.3.3.3 Does the forensic library contain current

books, journals and other literature dealing

with each functional area?

Yes No NA D

1.3.3.4 Does a system exist to encourage each

scientist to review appropriate new

literature?

Yes No NA D

1.4 Controlling 1.4.1 Evidence Control


1.4.1.1 Does the laboratory have a well defined

chain of custody record with all necessary

data which provides for complete tracking

of all evidence?

Yes No NA E

1.4.1.2 Is all evidence marked for identification? Yes No NA E

1.4.1.3 Is evidence stored under proper safe

custody

Yes No NA E

1.4.1.4 Is evidence protected from loss, cross

transfer, contamination and/or deleterious

change?

Yes No NA E

1.4.1.5 Is there a secure area for overnight and/or

long term storage of evidence?

Yes No NA E


1.4.2 Quality System (Please refer ISO/IEC

17025: 2005)


1.4.2.1 Does the laboratory have a quality

manual?

Yes No NA E

1.4.2.2 Is an individual designated as the Quality

Manager?

Yes No NA E

1.4.2.3 Are audits of the entire laboratory

operation completed annually?

Yes No NA E

1.4.2.4 Does the laboratory conduct an annual

review of its quality system?

Yes No NA E

1.4.2.5 Are the procedures used generally

accepted in the field or supported by data

gathered recorded in a scientific manner?

Yes No NA E

1.4.2.6 Are new technical procedures scientifically

validated before being used in casework

and is the validation documentation

available for review?

Yes No NA E

1.4.2.7 Are the technical procedures used by the

laboratory documented and are the

documents available to laboratory

personnel for review?

Yes No NA E

1.4.2.8 Are appropriate controls and standards

specified in the procedures and they used

to ensure the validity of examination a

results?

Yes No NA E

1.4.2.9 Is the quality of the standard samples and

reagents appropriate for the procedure

used?

Yes No NA E

1.4.2.10 Does the laboratory routinely check the

reliability of its reagents?

Yes No NA E

1.4.2.11 Are the instruments/equipment adequate

for the procedures used?

Yes No NA E


1.4.2.12 Are the instruments/equipment in proper

working orders?

Yes No NA E

1.4.2.13 Are the instruments/equipment properly

calibrated?

Yes No NA E

1.4.2.14 Do the scientists generate and does the

laboratory maintain, in a case record, all

the notes, worksheets, photographs,

spectra, printouts, charts and other data or

records used by examiners to support their

conclusions?

Yes No NA E

Methods and Procedures

1.4.2.15 Do the scientists in serology/DNA have

access to and generate local population

databases on the distribution of all genetic

markers, which are typed in the

laboratory?

Yes No NA E

1.4.2.16 Do the examiners in serology/DNA have

access to and generate local population

databases on the distribution of all genetic

markers which are typed in the laboratory?

Yes No NA E

1.4.2.17 Does the laboratory, conduct and

document administrative reviews of all

reports issued?

Yes No NA E

1.4.2.18 Does the laboratory monitor the testimony

of each Scientist at least annually and is

the Scientist given feedback from the

evaluation?

Yes No NA E

Corrective Action

1.4.2.19 If the laboratory has an indication of a

significant technical problem, is there a

procedure in writing and in use whereby

the laboratory initiates a review and takes

any corrective action required?

Yes No NA E


1.4.3 Proficiency Testing


1.4.3.1 Does the laboratory have a documented

program of proficiency testing?

Yes No NA E

1.4.3.2 Does the laboratory participate in

proficiency testing programmes conducted

by approved test providers?

Yes No NA E

1.4.3.3 Does the laboratory conduct inter or intra-

laboratory proficiency testing using the

blind, re-examination, or known standard

techniques?

Yes No NA E

2 Personnel Qualifications 2.1 Management


2.1.1 Does the laboratory Director possess a

degree in Natural Sciences or in

Criminalistics or is the laboratory Director

supported by scientific personnel of

sufficient managerial rank and authority?

Yes No NA E

2.1.2 Does the laboratory Director have at least

five years of forensic experience?

Yes No NA E

2.1.3 Does the laboratory Director have some

formal training in Management?

Yes No NA E

2.1.4 Does the laboratory Director have at least

two years of managerial experience?

Yes No NA E


2.2 Controlled Substances Standards and Criteria

2.2.1 Does each Reporting Officer have either

MSc with required experience or a

Bachelor Degree in Science or Forensic

Science

Yes No NA E

2.2.1.1 Does each have experience/training

commensurate with the examination and

testimony provided?

Yes No NA E

2.2.1.2 Does the Reporting Officer for Questioned

Documents have MSc in Physics or

Chemistry or Forensic Science with

specialization in document examination?

Yes No NA E

2.2.2 Does each Scientist understand the

instruments and the methods and

procedures used?

Yes No NA E

2.2.3 Did each Scientist successfully complete a

competency test prior to assuming case

work responsibility?

Yes No NA E

2.2.4 Did each Scientist complete an annual

proficiency test?

Yes No NA E

2.3 Toxicology Standards and Criteria

2.3.1 Does each Scientist have a Bachelor’s

degree in Natural Science, Toxicology or

Criminalistics and does each have

experience/ training commensurate with

the examinations and testimony provided?

Yes No NA E


instruments, and the methods and

procedures used?

Yes No NA E


2.3.3 Does each Scientist successfully complete

a competency test prior to assuming

casework responsibility?

Yes No NA E


proficiency test?

Yes No NA E

2.4 Trace Evidence Standards and Criteria

2.4.1 Does each Scientist possess a Bachelor’s

degree in Natural Science or in


experience/ training commensurate with

the examinations and testimony provided?

Yes No NA E



procedures used?

Yes No NA E


a competency test in each of the evidence

types processed prior to assuming


Yes No NA E


proficiency test?

Yes No NA E

2.5 Serology Standards and Criteria 2.5.1 Does each Scientist possess a Bachelor

Degree in Natural Science or in


experience/training commensurate with the

examinations and testimony provided?

Yes No NA E



procedures used?

Yes No NA E





Yes No NA E


proficiency test?

Yes No NA E

2.6 DNA Standards and Criteria

2.6.1 Does each Scientist have education,

training and experience consistent with

those recommended by the technical

working group on DNA analysis methods

(TWGDAM) in ‘Guidelines for a quality

assurance programme for DNA analysis’?

Yes No NA E



procedures used?

Yes No NA E




Yes No NA E

2.6.4 Did each Scientist complete two

proficiency tests annually?

Yes No NA E

2.7 Firearms/ Toolmarks Standards and Criteria


Degree with science courses?

Yes No NA E



procedures used?

Yes No NA E


2.7.3 Did each examiner have extensive training

from a qualified scientist and does each

have experience commensurate with the


Yes No NA E




Yes No NA E


proficiency test?

Yes No NA E

2.8 Questioned Documents Standards and Criteria


degree with science courses?

Yes No NA E



procedures used?

Yes No NA E





Yes No NA E




Yes No NA E


proficiency test?

Yes No NA E

2.9 Latent Prints Standards and Criteria


Degree with science courses?

Yes No NA E




procedures used?

Yes No NA E





Yes No NA E




Yes No NA E


proficiency test?

Yes No NA E

2.10 Technical Support Standards and Criteria

2.10.1 Do support personnel meet the

requirements of their job descriptions?

Yes No NA E

2.10.2 Are the job descriptions and the duties

performed in agreement?

Yes No NA E

2.10.3 If appropriate, did each member of the

support staff complete a competency test

prior to assuming casework responsibility?

Yes No NA E

2.10.4 If appropriate, was proficiency testing

completed?

Yes No NA E

3 Physical Plant 3.1 Space Standards and Criteria

3.1.1 Does each employee have adequate work

space to accomplish assigned tasks?

Yes No NA D


3.1.2 Is there sufficient space provided for

storage of supplies, equipment and tools?

Yes No NA D

3.1.3 Is there adequate space available for

Scientists for writing reports and other

official communication?

Yes No NA D

3.1.4 Is there adequate and appropriate space

available for records, reference works and

other necessary documents?

Yes No NA D

3.1.5 Is adequate space available for each

instrument to facilitate its operation?

Yes No NA D

3.1.6 Are accessories stored near each

instrument to facilitate its use and

operation?

Yes No NA D

3.2 Design Standards and Criteria

3.2.1 Does the physical design permit the

efficient flow of evidence from the time of

its acceptance until its proper disposal?

Yes No NA D

3.2.2 Do the relative locations of functional areas

facilitate the use of equipment and

instruments?

Yes No NA D

3.2.3 Is there adequate and proper lighting

available for personnel to carry out

assigned tasks?

Yes No NA D

3.2.4 Is there adequate and proper plumbing

and wiring available and accessible to

carry out assigned tasks?

Yes No NA D

3.2.5 Does the laboratory have proper general

ventilation?

Yes No NA D

3.2.6 Is the heating, cooling and humidity control

as the case may be, in the laboratory

adequate?

Yes No NA D


3.3 Security Standards and Criteria

3.3.1 Does each employee have adequate work

space to accomplish assigned tasks?

Yes No NA D

3.3.2 Doe all exterior entrance / exit points have

adequate security control?

Yes No NA D

3.3.3 Do all internal areas requiring

limited/controlled access have a lock

system?

Yes No NA D

3.3.4 Are all keys, magnetic cards, etc.,

accounted for and is their distribution

limited?

Yes No NA D

3.3.5 Is the laboratory secured during vacant

hours by means of an intrusion alarm or,

by security personnel?

Yes No NA D

3.3.6 Does the laboratory have a fire detection

system?

Yes No NA D

3.4 Health and Safety Standards and Criteria

3.4.1 Does the laboratory have an effective

health and safety programme documented

in a manual?

Yes No NA D

3.4.2 Is an individual designated as the health

and safety manager?

Yes No NA D

3.4.3 Is the health and safety programme

monitored regularly and reviewed annually

to ensure that its requirements are being

met?

Yes No NA D


3.4.4 Does the laboratory have available and

encourage the use of safety services,

particularly those required by its health and

safety manual?

Yes No NA D

3.4.5 Does the laboratory have proper

equipment and material available for the

handling of carcinogenic, toxic and/or other

dangerous material spills?

Yes No NA D

3.4.6 Does the laboratory have safety shower

and eye wash equipment in appropriate

locations and in good working condition?

Yes No NA D

3.4.7 Are sufficient exhaust hoods available to

maintain a safe work environment?

Yes No NA D

3.4.8 Are sufficient first –aid kits available and

strategically located?

Yes No NA D

3.4.9 Does the laboratory have an adequate

number of personnel trained in first –aid

procedures?

Yes No NA D

3.4.10 Is appropriate space provided for safe

storage of volatile, flammable and

explosive materials?

Yes No NA D

3.4.11 Are the emergency exits from the

laboratory adequate for safe exit in an

emergency?

Yes No NA D

3.4.12 Is there general cleanliness and apparent

good housekeeping in the laboratory?

Yes No NA D

National Accreditation Board for Testing and Calibration Laboratories 3rd Floor, NISCAIR

14, Satsang Vihar Marg New Mehrauli Road New Delhi – 110 067

Tel.: 91-11 26529718 – 20, 26526864 Fax: 91-11 26529716

Website: www.nabl-india.org