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Quality Management System

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Author:
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Review by

Heidi Hanes

Document Number:
Effective (or Post) Date:
Company:
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Review date

Doc00-14
21 Oct 09
BHHRL
Penny Stevens
9-Feb-12

SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your labs specific processes
and/or specific protocol requirements. Users are directed to countercheck facts when considering their use in other applications. If you
have any questions contact SMILE.

Botswana-Harvard HIV
Reference Laboratory
(BHHRL)

Quality Management System


Document Control and
Management

Document No.:
BHHRL/001PR01
Version : 2

Tel: +267 3902671;


Fax: +267 3901284

Title:

Prepared By:

Document Control and Management

Name, Title
Munyaradzi P. Mangwendeza, Quality Manager

Signature, Date

Name, Title

Signature, Date

Approved By:

Review Date

Revision Date

Signature, Date

Annual Review

Distributed To:

Location:
Master file
Director
Lab Manager

Copy Number:
1
2
3

Location:

Copy Number

Copy Number:_________
________________________________________________________________________________________________
Effective Date: 01/12/2007
Page 2 of 11
Confidential Controlled Document

Botswana-Harvard HIV
Reference Laboratory
(BHHRL)

Quality Management System


Document Control and
Management

Document No.:
BHHRL/001PR01
Version : 2

Tel: +267 3902671;


Fax: +267 3901284

1. General Policy
1.1.
All documents and data are reviewed and approved by authorized
personnel prior to use. Current revisions of appropriate documents are available
at locations where they are used. Obsolete documents are removed from points of
use.
2. Purpose
2.1.
To assure that Quality Management System documents
used by BHHRL employees are properly developed, approved,
active and located where needed.
2.2.
The following types of documents are controlled by the
document control procedure:
2.2.1. Quality Manual, Standard Operating Procedures (SOPs) and
forms, Quality Plans and Test Plans
2.2.2. Work instructions
2.2.3. Regulations, standards and other reference materials
3. Scope
3.1.
This procedure applies to the control of documents,
including electronic and external, affecting quality such as
methods, regulations, directives, procedures and instructions,
pertaining to the BHHRL Quality Management System (QMS).
4. Responsibilities
4.1.
Quality Manager
4.1.1. Implements and maintains document control system,
4.1.2. Coordinates reviews and revisions of quality system
documents,
4.1.3. Maintains Master Index to ensure active and revised
documents are provided to staff. Master Index must contain,
Document Number, Title, Revision Level and Review date.
4.1.4. Archives superseded or obsolete documents.
________________________________________________________________________________________________
Effective Date: 01/12/2007
Page 3 of 11
Confidential Controlled Document

Botswana-Harvard HIV
Reference Laboratory
(BHHRL)

Quality Management System


Document Control and
Management

Document No.:
BHHRL/001PR01
Version : 2

Tel: +267 3902671;


Fax: +267 3901284
4.1.5. Reviews SOP prior to use
4.1.6. Ensures that all routine operations and activities are
documented by SOPs.
4.1.7. Creates or delegates creation of documents.
4.2.
Staff
4.2.1. Responsible for verifying that the official version of the
document is used by checking the Master List kept by the
Quality Manager.
4.2.2. Reviews and determines need for new procedures or
revision of procedures and to convey that need to their
immediate supervisor or Quality Manager.
4.2.3. May also initiate changes and creation of documents by
completing a Document Change Request (DCR) form,
4.2.4. It is the responsibility of the author of an SOP to include
sufficient detail that the process or procedure can be
followed by another person when needed.
4.3.
Laboratory Manager
4.3.1. Approves and authorizes all technical standard operating
procedures.
4.4.
Director
4.4.1. Approves and authorizes all standard operating procedures
5. Procedural Steps
5.1.
Preparing SOPs
5.1.1. Identify the need for an SOP or the revision of an existing
one by informing the supervisor or Quality Manager.
5.1.2. Once the need for a particular SOP is established, it should
be drafted immediately.
5.1.3. SOPs are drafted by the laboratory or supervisory staff
qualified to perform the procedure. Next the SOP is reviewed
by other staff, where possible and then approved by the
appropriate authorities. Circulation to staff prior for
review/comment is advisable prior to acquiring management
approval.

________________________________________________________________________________________________
Effective Date: 01/12/2007
Page 4 of 11
Confidential Controlled Document

Botswana-Harvard HIV
Reference Laboratory
(BHHRL)

Quality Management System


Document Control and
Management

Document No.:
BHHRL/001PR01
Version : 2

Tel: +267 3902671;


Fax: +267 3901284
5.1.4. The SOPs should be written to describe methods or
processes in sufficient detail so as to ensure the quality and
integrity of the data or procedure to be followed.
5.1.5. When writing SOPs, the detail may include both procedural
requirements (exact instructions) and guidance information
(general information) on the procedure.
5.1.6. Procedural requirements must be followed exactly, while
guidance information is used to help perform the procedure;
it is not a mandatory requirement and therefore it does not
have to be followed exactly.
5.1.7. Procedural requirements can be distinguished from
guidance elements, based on the context they are used (e.g.
MUST or SHALL indicate the action as a procedural
requirement and command statements)
5.1.8. Follow the BHHRL standard format for margins, font and
font size.
5.1.9. Official SOPs will have a header and footer, dated
signatures on the front page.
5.1.10. Use an outline format and include alpha and/or numeric
characters to indicate levels of information.
5.1.11. The SOP/Documents must include:
1. Header and footer, detailing:
a. SOP number, assigned by the Quality Manager, is
based on defined categories
b. Page number in the format: Page X (current page) of
Y (total number of pages)
c. Revision number ( new SOPs will be indicated by the
use of a 1 and subsequent revisions will be marked
2,3,4 e.t.c)
d. Effective date ( date when procedure has been
approved by all parties for use)
2. Title page
Identifier/Title
Signature lines minimally for author, Quality
Manager, Laboratory Manager (for technical
documents only), Director
Copy number
Distribution
________________________________________________________________________________________________
Effective Date: 01/12/2007
Page 5 of 11
Confidential Controlled Document

Botswana-Harvard HIV
Reference Laboratory
(BHHRL)

Quality Management System


Document Control and
Management

Document No.:
BHHRL/001PR01
Version : 2

Tel: +267 3902671;


Fax: +267 3901284
3.
4.
5.
6.

Table of contents
Policy, Purpose and Scope
Principle (Technical documents)
Definitions (if any terms need to be defined.) and
Abbreviations
7. Personnel responsibilities
8. Health and safety warnings and Cautions (primarily for
technical SOPs)
9. Interferences (primarily for technical SOPs)
10.
Equipment and Supplies((Primarily for technical
SOPs)
11.
Procedural Steps
12.
Data and Records Management
13.
Co-applicable documents
14.
Quality Assurance and Quality control
15.
References
16.
Document revision history
17.
Appendix for staff signatures
5.2.
Numbering Documents
5.2.1. Documents are numbered sequentially
assignment to a specific category, such as
001 Quality Management System
002 Sample Management
003 CD4 Lab
004 Viral Load Lab
005 Haematology Lab
006 Serology Lab
007 DNA PCR Lab
008 Clinical Chemistry Lab
009 Health and Safety
010 Administration and Supplies
011 PBMC Lab
012 Research Lab

based

on

Type of document;
QM Quality Manual
PL Policies

________________________________________________________________________________________________
Effective Date: 01/12/2007
Page 6 of 11
Confidential Controlled Document

Botswana-Harvard HIV
Reference Laboratory
(BHHRL)

Quality Management System


Document Control and
Management

Document No.:
BHHRL/001PR01
Version : 2

Tel: +267 3902671;


Fax: +267 3901284

HS Health and Safety


PR Procedures
TM Test Methods
WI Work Instructions
EM Equipment Manuals
FR Forms
EOI Equipment Operation Instructions
TX Text books

5.2.2. The document number will appear as BHHRL, followed by 3


digit number for category, 2/3 letters for type of document
and 3 digits for number within type.
5.2.3. The first approved version of an SOP will be numbered as 1.0. Reviews
that result in minor changes are numbered as 1.1 etc. and 2.0 for major
changes.
5.2.4. The Quality Manager is responsible for assigning SOP
numbers and determining category. Numbers are assigned
sequentially and may only be used once, i.e., numbers
cannot be re-used even if a procedure is eliminated or
incorporated into another SOP.
5.3.
Document indexing
5.3.1. Each document will be listed numerically in the Appendix in
the Quality Manual.
5.4.
Revising Documents
5.4.1. If the SOP does not accurately describe the procedure,
then the SOP must be revised. Any change in the procedure
must be incorporated into the SOP. However, prior to any
change to the SOP, management must be advised of, and
approve, the change.
5.4.2. Finalized SOPs, containing typographical errors, printing
errors, e.g. wrong page numbers or misaligned sentences) or
any errors that do not affect the scope of the procedure may
be corrected immediately and reprinted. These types of
errors do not require full SOP revision, thus the Revision
number will not be generated and management approval is
not needed. If the error occurs on the signature page then
________________________________________________________________________________________________
Effective Date: 01/12/2007
Page 7 of 11
Confidential Controlled Document

Botswana-Harvard HIV
Reference Laboratory
(BHHRL)

Quality Management System


Document Control and
Management

Document No.:
BHHRL/001PR01
Version : 2

Tel: +267 3902671;


Fax: +267 3901284
the signature page will be resigned. These types of
corrections will be traceable since the historical file will
reflect all corrections including typographical errors.
Specifically, the historical SOP file will contain both the SOP
with the correct pages as well as the pages containing the
error. The page with the error will not be removed from the
historical file.
5.4.3. Additions can be made to an SOP via a clarification or an
addendum
5.4.4. Clarifications and addendums must be attached to the
applicable SOP until such a time that the SOP can be revised.
Generally, the revision will be incorporated during the annual
review process.
5.4.5. Hand written amendments are acceptable, providing all
copies of the document are clearly marked, initialed and
dated. Explanation of the amendment should be
documented. Formal revisions of these will be issued during
annual review.
5.4.6. When the SOP is revised, the revision number is updated.
Revisions, clarifications and addenda are prepared by the
appropriate personnel but must be approved by
management.
5.4.7. An SOP can be eliminated or made obsolete when it is no
longer applicable. Management must approve the
elimination of the SOP. Two or more SOPs can be
consolidated; in this case one SOP supercedes the other, but
management approval is required for consolidation of
procedures.
5.4.8. The signed copy of a revised SOP must be sent to the
historical file for archiving.
5.5.
Using SOPs
5.5.1. Prior to performing a procedure for the first time, the
individual must document in writing that they have read and
reviewed the specific SOP.
5.5.2. In addition, the Staff should review all SOPs at least once a
year to ensure that each SOP accurately describes the
procedure in use. The review will be documented in writing in
________________________________________________________________________________________________
Effective Date: 01/12/2007
Page 8 of 11
Confidential Controlled Document

Botswana-Harvard HIV
Reference Laboratory
(BHHRL)

Quality Management System


Document Control and
Management

Document No.:
BHHRL/001PR01
Version : 2

Tel: +267 3902671;


Fax: +267 3901284
the form of signatures. SOP review signature logs will be
maintained in the QM office.
5.5.3. All procedures must be performed in accordance with the
written SOPs.
5.5.4. If a given procedure is not performed in accordance with
the pertinent SOP, then all SOP deviations must be written to
document the change in the procedure
5.5.5. The Lab Manager must be informed and must acknowledge
in writing the occurrence of the SOP deviation and must
determine the effect, if any, the deviation may have on the
integrity of the data.
5.5.6. All deviations must be filed with the test information.
5.6.
Access and location of SOPs
5.6.1. Appropriate SOP s will be placed in files to be found in a
designated spot in each work area and shall be available to
all concerned personnel. The files should not be located in
the supervisors office. Removal of an individual SOP from a
file requires the completion of a sign-out form located in the
file. The section supervisor approves this.
5.6.2. It is the responsibility of the Quality Manager to update
each SOP file as individual SOPs are revised.
5.6.3. Staff is required to read any revised SOP within 7 working
days of issuance if the SOP is applicable to their work.
5.6.4. Reading of the updated SOP requires signature on the SOP
review sheet.
5.7.
Document Retention
5.7.1. A historical file is created for each document that is
approved by management and will be maintained in the
archives by the Quality Manager.
5.7.2. The historical file will consist of the original signed
document and all subsequent modifications thereof including
the current document.
5.7.3. If a procedure is incorporated into another SOP
(superseded) a copy of the superseded version is placed in
the historical file of both SOPs.
5.8.

Obsolete Documents

________________________________________________________________________________________________
Effective Date: 01/12/2007
Page 9 of 11
Confidential Controlled Document

Botswana-Harvard HIV
Reference Laboratory
(BHHRL)

Quality Management System


Document Control and
Management

Document No.:
BHHRL/001PR01
Version : 2

Tel: +267 3902671;


Fax: +267 3901284
5.8.1. Obsolete documents that a retained for reference or legal
obligations are marked OBSOLETE and are kept separate
from active documents. Obsolete electronic documents are
removed from the network and are stored in media that are
only accessible to authorized personnel. Any obsolete
documents that need to be reactivated must be reviewed,
approved and released in the same manner as newly
established documents.
5.8.2. At least one copy of all obsolete documents must be
archived.
5.9.
Electronic Documents
5.9.1. Electronic documents are writing protected and controlled
by the Quality Manager. Requests for revisions to electronic
documents must be made to the Quality Manager. All
electronic documents indicate the approval signatures
required.
6. Quality Assurance and Quality Control
6.1.
All SOPs are reviewed by Quality Manager/Lab Manager
with assistance from the applicable supervisor at least once a
year in order to maintain relevance.
6.2.
Before January 31st of each calendar year, a list of all SOPs
which have been revised are provided to the Quality Manager by
the supervisors. Due to the large numbers of documents,
different lab sections can be scheduled for review throughout
the year and Quality Manager keeps documentation of this.
6.3.
For those SOPs that do not require a revision,
documentation attesting to that fact must be submitted to the
Quality Manager who in turn initials and dates the table located
at the end of the original SOP.
6.4.
All manuals and SOPs distributed shall have copy numbers
written in coloured pen.
6.5.
All signatures on documents shall appear in coloured pen
to clearly distinguish them form copies.
7. Records
7.1.
Documents Master Index
7.2.
Document Change Request Form
________________________________________________________________________________________________
Effective Date: 01/12/2007
Page 10 of 11
Confidential Controlled Document

Botswana-Harvard HIV
Reference Laboratory
(BHHRL)

Quality Management System


Document Control and
Management

Document No.:
BHHRL/001PR01
Version : 2

Tel: +267 3902671;


Fax: +267 3901284
7.3.
7.4.
7.5.
7.6.

Document Retention Programme.


SOP Historical File
Document Review Schedule
Document Creation Request Form

8. References
8.1.
Quality Manual. BHHRL. Current Version
Revision History:
Revision Revision
Level:
Date:

Revised By:

Brief description of revision:

________________________________________________________________________________________________
Effective Date: 01/12/2007
Page 11 of 11
Confidential Controlled Document