STANDARD OPERATING PROCEDURE (SOP):
The term standard operating procedure,
or SOP, is used in a variety of different contexts, including
healthcare, aviation, engineering, education, industry, government, military,
e.t.c.,
SOP is widely used to maintain
Quality, efficacy, safety of the work /procedure with respect to regulatory
needs…
DEFINITION:
"A Standard Operating
Procedure is a document which describes the regularly recurring operations
relevant to the quality of the investigation. The purpose of a SOP is to carry
out the operations correctly and always in the same manner. A SOP should be
available at the place where the work is done".
A SOP is a compulsory
instruction. If deviations from this instruction are allowed, the conditions for
these should be documented including who can give permission for this and what
exactly the complete procedure will be. The original should rest at a secure
place while working copies should be authenticated with stamps and/or
signatures of authorized persons.
Several categories and types of SOPs
can be distinguished. The name "SOP" may not always be appropriate,
e.g., the description of situations or other matters may better designated
protocols, instructions or simply registration forms. Also worksheets belonging
to an analytical procedure have to be standardized (to avoid jotting down
readings and calculations on odd pieces of paper).
In
general, numbers of important SOP types are:
-
Fundamental SOPs. These give instructions how to make SOPs of the other
categories.
- Methodical SOPs. These describe a complete testing system or method of
investigation.
- SOPs for safety precautions.
- Standard procedures for operating instruments, apparatus and other equipment.
- SOPs for analytical methods.
- SOPs for the preparation of reagents.
- SOPs for receiving and registration of samples.
- SOPs for Quality Assurance.
- SOPs for archiving and how to deal with complaints.
INITIATION OF SOPs:
As implied above, the initiative
and further procedure for the preparation, implementation and management of the
documents is a procedure in itself which should be described. These SOPs should
at least mention:
a. who can or should make which
type of SOP;
b. to whom proposals for a SOP
should be submitted, and who adjudges the draft;
c. the procedure of approval;
d. who decides on the date of
implementation, and who should be informed;
e. how revisions can be made or
how a SOP can be withdrawn.
It should be established and
recorded who is responsible for the proper distribution of the documents, the
filing and administration (e.g. of the original and further copies). Finally,
it should be indicated how frequently a valid SOP should be periodically
evaluated (usually 2 years) and by whom. Only officially issued copies may be
used, only then the use of the proper instruction is guaranteed.
In the laboratory the procedure
for the preparation of a SOP should be as follows:
The Head of Laboratory (HoL)
charges a staff member of the laboratory to draft a SOP (or the HoL does this
himself or a staff member takes the initiative). In principle, the author is
the person who will work with the SOP, but he or she should always keep in mind
that the SOP needs to be understood by others. The author requests a new
registration number from the SOP administrator or custodian (which in smaller
institutes or laboratories will often be the HoL). The administrator verifies
if the SOP already exists (or is drafted). If the SOP does not exist yet, the
title and author are entered into the registration system. Once the writing of
a SOP is undertaken, the management must actively support this effort and allow
authors adequate preparation time.
In case of methodical or
apparatus SOPs the author asks one or more qualified colleagues to try out the SOP.
In case of execution procedures for investigations or protocols, the project
leader or HoL could do the testing. In this phase the wording of the SOP is
fine-tuned. When the test is passed, the SOP is submitted to the SOP
administrator for acceptance. Revisions of SOPs follow the same procedure.
PREPARATION OF SOPs:
For writing and making the SOP
should meet minimum number of requirements:
1. Each page should have a header & Footer by
mentioning:
a. Date of approval and/or version number;
b. A unique title (abbreviated if desired);
c. The number of the SOP (preferably with
category);
d. Page number and total number of pages of the SOP.
e. The heading (or only the logo) of originals
should preferably be printed in another colour than black.
2. The first page, the title page, should
mention:
a. general information mentioned under point 1. mentioned above, including the complete
title;
b. a summary of the contents with purpose and
field of application (if these are not evident from the title); if
c. desired the principle may be given, including
a list of points that may need attention;
d. any related SOPs (of operations used in the
present SOP);
e. possible safety instructions;
f.
name and
signature of author, including date of signing. (It is possible to record the
authors centrally in a register);
g. name and signature of person who authorizes
the introduction of the SOP (including date).
3. The necessary equipment, reagents (including
grade) and other means should be detailed.
4. A clear, unambiguous imperative description
is given in a language mastered by the user.
5. It is recommended to include criteria for the
control of the described system during operation.
6. It is recommended to include a list of
contents particularly if the SOP is lengthy.
7. It is recommended to include a list of
references.
Categories can be denoted with a
letter or combination of letters, e.g.:
Ø F for fundamental SOP
Ø A or APP for apparatus SOP
Ø M or METH for analytical method SOP
Ø P or PROJ for procedure to carry out a
special investigation (project)
Ø PROT for a protocol describing a sequence of
actions or operations
Ø ORG for an organizational document
Ø PERS for describing personnel matters
Ø RF for registration form (e.g. chemicals,
samples)
Ø WS for worksheet (related to analytical
procedures)
STORAGE OF SOPs:
The data which should be stored
per document are:
Ø SOP number
Ø Version number
Ø Date of issue
Ø Date of expiry
Ø Title
Ø Author
Ø Status (title submitted; being drafted; draft
ready; issued)
Ø Department of holders/users
Ø Names of holders
Ø Number of copies per holder if this is more
than one
Ø Registration number of SOPs to which
reference is made
Ø Historical data (dates of previous issues)
The SOP administrator keeps at
least two copies of each SOP; one for the historical and one for the back-up
file. This also applies to revised versions. Superseded versions should be
collected and destroyed (except the copy for the historical file) to avoid
confusion and unauthorized use.
Examples of various categories of
SOPs will be given in the ensuing chapters. The contents of a SOP for the
administration and management of SOPs can be distilled from the above.
ORDER FOR PREPARATION OF SOP:
1.0 Aim & Objective
2.0 Scope
3.0 Responsibility
4.0 Accountability
5.0 Definitions & Abbreviations
6.0 Procedures
7.0 Reference
8.0 Enclosure
Example to prepare sop and explaining
how to prepare sop as follows:
1.0 Objective
To lay down
an approved procedure for the Preparation, Distribution, Review, Retrieval and
Archival of Standard Operating Procedure.
2.0 Scope:
This
procedure is applicable to the preparation, distribution, review, retrieval and
archival of Standard Operating Procedure used in Quality Assurance, Quality
Control, Production and Stores Departments.
3.0 Responsibility
Manager-Quality Assurance
4.0 Accountability
General
Manager
5.0 Definitions
5.1 Standard
Operating Procedure: Standard Operating Procedure is a logical sequence of
events in instructional form for performing the activities.
5.2 MASTER
COPY: The first copy of Standard Operating Procedures that bears original
signatures are stamped ‘MASTER COPY’ in red ink, at the top left corner.
5.3 CONTROLLED
COPY: A photocopy of the Master Copy along shall be stamped as ‘CONTROLLED
COPY’ in Green ink with Sign and Date at the bottom left corner that shall be
used with in the organization and is distributed to a limited number of
authorized document holders.
5.4 DISPLAY
COPY: A photocopy of the Master Copy stamped as ‘DISPLAY COPY’ at the Top Right
corner in Red ink.
5.5 UNCONTROLLED
COPY: A photocopy of the Master Copy for the use of customers / external
agencies shall be stamped as ‘UNCONTROLLED COPY’ in Red ink across the centre
of each page.
5.6 TRAINING
COPY: A photocopy of the Master Copy shall be stamped as ‘TRAINING COPY’ in Red
ink in the bottom right corner of each page. The training shall be conducted to
all users in the department.
5.7 OBSOLETE
COPY: The superseded Master copy of any document or a copy of any discontinued
document that is taken out of use is stamped as ‘OBSOLETE COPY’ in red ink in
the bottom right corner of each page.
6.0 Procedure
6.1 Design of standard operating procedure:
6.1.1 The
standard operating procedure shall be created in specific format (refer)
QA GP:001:F01:00
6.1.2 SOP shall be prepared by using Microsoft word on A4 size paper. The text
shall be in ‘Normal’ style with ‘Times new roman’ ‘Regular’ font size of 12.
Single line spacing shall be assigned between lines and paragraphs.
6.1.3 The header shall contain company logo, name and location, title, page
number, sop number, revision number, date of issue and effective date.
6.1.4 Footer
shall have the provision for the signature, date and designation of the
prepared by, checked by and approved by.
6.1.5 Each
page of standard operating procedure shall be consecutively numbered indicating
page the number and the total number of pages in the sop. E.g. page 1 of 2and 2
of 2.
6.1.6 The
sections shall be serially numbered using Arabic numeral starting for 1.0and
the subsections of each section shall also be serially numbered as 1.1, 1.2,
and so on. Its subsections shall further be numbered as 1.1.1, 1.1.2 and so on.
E.g. 1.0
1.1
1.1.1
6.1.7 After
the completion of the sop shall be signed and dated along with the designation
of the signatories.
6.2 Identification of Standard Operating
Procedure:
6.2.1
Purpose: objective of writing the particular sop. It should start with the
phrase ‘to lay down an approved procedure…………..’
6.2.2 Scope:
the area / equipment/ instrument/ facility/ system/ department/ personnel to
which the procedure applies.
6.2.3
Responsibility: the designation of the person(s) who are directly responsible
for carrying out the activity mentioned in the purposed of the sop.
6.2.4
Accountability: The designation of the person(s) who are accountable for
complying the sop.
6.2.5
Definitions: Meaning of the unique terms used in the sop.
6.2.6
Procedure: Detailed stepwise activities to be performed and shall be written in
a simple language with simple sentence structure step by step.
6.2.7 Reference:
Other documents referred for the preparation of the sop.
6.2.8 Enclosures: Formats required for recording the information such as
formats, lists, tables, checklists and labels
shall be attached with the sop.
6.2.9
Abbreviations: Full form of the abbreviations shall be used in first afterwards
short forms shall be used. All abbreviations used in the sop shall be mentioned
in this section.
6.3 Numbering of Standard Operating
Procedure:
6.3.1 SOP
shall be identified by an alphanumeric numbering system.
6.3.2 SOP
shall be numbered with 4 alphabets; first 2 alphabets specify
department
and other 2 alphabets specify the functional subgroup and Arabic numerical
serial number in 3 digits starting from 001.
6.3.3
Department code for Quality Assurance Department shall be ‘QA’ and it should be
the first two letters of all the SOPs indicating that the particular SOP
belongs to Quality Assurance Department.
6.3.4
Functional subgroup code (2 alphabets) shall be assigned as per functional area
where the sop is applicable.
6.3.5 The
following functional subgroup codes that shall be used in SOP:
GP: General Procedures
EO: Equipment Operating Procedure
IO: Instrument Operating Procedure
EC: Equipment Cleaning Procedure
CL: Calibrating Procedure
6.3.6 The department code along with functional subgroup code shall be the
first part, which will then be followed by a colon further followed by serial
number.
E.g. PREO:001, where PR- Department Code ( i.e. Production Department)
EO- Functional Subgroup Code (Equipment Operation)
001-Arabic numeral serial number (Specifies a particular SOP)
6.3.7 Design and Numbering of formats:
6.3.7.1 The
format shall have header with company logo, name of the organization, title of
the format, page number and effective date. The format number along with the
revision number shall be mentioned in the bottom right corner of each page
(Refer Format No. QAGP:001:F02:00)
6.3.7.2
Format shall have identification SOP number based on the procedures under which
they are prepared. Format prepared under a procedure shall be serially
numbered. Final copy of the format shall bear the signature of the authorized
person along with date, specifying the copy as Master Copy.
6.3.7.3
Formats shall be issued as electronic copies with the QA issued, sign and date
stamping on the formats. QA personnel shall sign and date during issue.
6.3.7.4 The
photocopy of the master format shall be taken and stamped as ‘CONTROLLED COPY’
in Green ink along with sign and date.
6.3.7.5 The
photocopies of the controlled copy format shall be stamped with QA issued with
sign and date and distributed to the departments.
6.3.7.6 The department code along with functional subgroup code which is 4
alphabets shall be the first part, which will then be followed by colon further
followed by a serial number and a colon, and then format number in alpha
numeric followed by a colon, and the revision number. E.g. the first format of
an SOP designed shall have the format number as, QAGP:001:F01:00.
6.3.7.7 The labelling formats shall be same as the order of the format.
E.g. QAGP:001:L01:00.
6.3.7.8 If
the format undergoes a change, the revision number shall be changed to the next
number.
6.4 Preparation and Distribution of Standard
Operating Procedure:
6.4.1 The
person responsible for the preparation of SOP shall prepare a Draft Copy and
stamp it as DRAFT COPY in Red ink, in the left column provided in the footer of
each page and circulate for suggestions or corrections if any.
6.4.2
Necessary corrections shall be made based on the feedback and a final print out
to be taken and the Draft Copy to be destroyed.
6.4.3 The
final copy of the SOP shall be signed in original shall be termed as master
copy. This shall be indicated by stamping ‘MASTER COPY’.
6.4.4 Once
the SOP is authorized and stamped as ‘MASTER COPY’, no manual corrections shall
be allowed in the SOP.
6.4.5.
Master list of SOPs shall be prepared as an index as per the format
QAGP:001:F03:00. The master list shall be prepared for each department and
functional subgroups and shall be coded as first three letters MLS indicating
Master List of SOP followed by a colon and the department and functional
subgroup and a colon followed by three digit numerical revision number starting
from 001. If the Master List undergoes revision the serial it shall be changed
into the next revision number. E.g. The Master List of SOPs for the Quality
Assurance General Procedure Department shall be written as MLS:QAGP:001.
6.4.6 The
required number of copies required to be distributed to be made by photocopying
the Master Copy and enter the details in the ‘SOP Issue and Withdrawal Control
Sheet’(refer Format QAGP:001:F04:00) and attached with each Master copy of the
SOP.
6.4.7. If a
copy of a particular SOP is required by outside agency then the copy shall be
stamped as ‘UNCONTROLLED COPY’ with the consent and in consultation with QA
Manager.
6.4.8 No SOP
shall be copied by anyone other than the concerned person for any purpose. If
such copies are made they will be treated as unauthorized / unofficial.
6.4.9 All
the previous versions ‘CONTROLLED Copies’ and ‘Display Copies’ shall be
retrieved and destroyed while issuing the new amended versions. The old version
Master copies shall be stamped as ‘OBSOLETE COPY’ and retained with the
department for future reference only.
6.5 Review of Standard Operating Procedure:
6.5.1 SOP
shall be periodically reviewed before 15 days of completion of two years or as
and when there is any relevant intermittent change in the SOP required.
6.5.2 The
concerned head of the department shall review the ‘SOP Review Sheet’ Refer
format QAGP:001:F05:00.
6.5.3 If any
change is required it shall be noted in the change control form as per the
change control procedure. Any change in the SOP/format, the SOP shall be
revised to the next revision number.
6.5.4 If the
SOP undergoes review, the revision shall be mentioned in the revision number
column as 01 for first version, 02 for second version and so on for new SOP
revision number will be 00. if any SOP number is required to specify in some
other document for reference, only the SOP number shall be specified without
the revision number.
6.6 Changes to the SOP:
6.6.1 Any
change to the SOP shall be made as per instructions given in Change Control SOP
6.6.2
Whenever any SOP/format undergoes a change the revision number shall change to
the next number. A brief description of the change recorded in the SOP Review
Sheet.
6.6.3 The
amended documents shall be distributed as per the instruction in section 6.4
onwards.
6.6.4 All
the controlled copies and Display copies of the superceded SOP shall be
withdrawn and destroyed before issuing the amended SOP.
6.6.5 The
Master Copy of the superceded SOP shall be stamped as Obsolete Copy and shall
be held in the department for future reference. A record of destruction shall
be made in column provided in the SOP Control Sheet and attached to the
obsolete copy.
6.6.6 Master
List of SOP shall be revised and maintained separately.
6.7 Retrieval of Standard Operating
Procedure:
6.7.1 All
the previous versions Controlled Copies and Display copies shall be retrieved
and destroyed before issuing the new amended versions. The Master Copies shall
be stamped as ‘OBSOLETE COPY’ and retained in the department for future
reference.
6.8 Storage of Standard Operating Procedures:
6.8.1 All
master copies of the SOP to be stored under lock and key. It shall be easily
retrievable but access to be limited only to the authorized persons.
6.8.2
Obsolete copies shall be filed and stored separately from that of the current
versions of the master copies.
6.9 Control of data in computer:
6.9.1 Any
instruction/information/data stored in computer hard disc/electronic copies
shall not be considered as official for regulatory purposes. The approved
copies that are signed shall be considered as official documents.
6.10 Archival of Standard Operating Procedures:
6.10.1
Obsolete SOP shall be stored for 5 years from the superceded date.
6.10.2 After
the storage period the obsolete SOP shall be torn into pieces and put to fire
for destruction.
7.0 Reference
Add the
References on what basis you prepare the SOP.
8.0 Enclosure
Attach the
Annexures copy to enter data if available .
