GLP SOPs for Equipment Calibration

and Maintenance. Part 5:

SOP Templates and SOP on SOPs
Irina Colligon1, and Michelle Rosa2
1
Downingtown, PA, USA
2
Bethlehem, PA, USA

Summary
Document templates are valuable tools and Standard Operating Procedure
(SOP) templates are no exception. The true value of the SOP on SOPs is often
underestimated. This installment of the series is dedicated to the discussion of
the SOP on SOPs and of the SOP templates, their use and ways of making them
better. Copyright r 2008 John Wiley & Sons, Ltd.

Key Words: Standard Operating Procedures; SOPs; GxP; GLP; SOP templates

All parts should go together without forcing.
You must remember that the parts you are
reassembling were disassembled by you. There-
fore, if you cant get them together again, there
must be a reason. By all means, do not use a
hammer.
IBM Maintenance Manual (1925)
SOP on SOPs
An informal comparison of a handful of SOPs
on SOPs will quickly reveal a great variety. At
one end of the spectrum there are documents
that provide detailed instructions on how to
form sentences, layout, format and print the
SOPs. At the other extreme are documents that
limit themselves to simply stating that SOPs will
exist. There is value in both but, as always, the
real answer lies somewhere in the middle.
In our opinion, there are two key goals of an
SOP on SOPs:

What does it mean every organization

should have an SOP on SOPs? 1. To describe how the life cycle of any SOP
Combinations of laughter, amused looks and is managed from its inception through
knowing smirks are the almost invariable re- retirement.
actions a mention of the SOP on SOPs elicits 2. To provide readers with the explanation on
from newcomers to the world of SOPs. In how the SOPs are used.
contrast, the SOP insiders often create rather
elaborate structures behind the SOP on SOPs. Two additional tools should further support
the SOP itself:

*Correspondence to: I. Colligon, 4 LaFitte Court,

Downingtown, PA 19335, USA. E-mail: irinacolligon@ 1. A template that defines the appearance of
Comcast.net the SOPs.

Qual Assur J 2007; 11, 295301.

Copyright r 2008 John Wiley & Sons, Ltd. DOI: 10.1002/qaj.427
296 I. Colligon and M. Rosa

2. A guideline that provides direction on the 1. Actual drafting of the SOPs.

verbiage, etc.
Although an SOP on SOPs affects everyone in
the organization, the audiences for the procedural
portions of the two components of the SOP on
SOPs are different. The use portion is addressed
to all who must follow any of the SOPs, i.e.,
everyone in the organization. The target of the
life-cycle portion is much smallerit comprises
those who manage the SOPs. All other sections of
the SOP on SOPs are geared toward everyone.
SOP Life Cycle
The life cycle of an SOP is not very different
from the life cycle of any other regulated
document. It can be summed up in a simple
diagram shown in Figure 1.
Except for the starting point, the procedures
that take place between the initial draft and im-
plementation of the final, approved document are
fundamentally the same whether creating a totally
new SOP or revising a previously issued one, as
shown in Figure 1, Boxes 1 and 3.2, respectively.
Among the important topics regarding the
life cycle of SOPs that need to be addressed in
the SOP on SOPs are:
2. Ensuring consistency of the proposed
SOPs with regulations, corporate policies,
etc.
3. Frequency of SOP reviews.
4. What to do if the periodic review shows
that an SOP does not require revision.
5. Dealing with major, permanent SOP
usability problems uncovered before the
scheduled review.
6. Managing minor changes to an SOP. In the
context of this discussion, minor changes
are those that do not affect the actual
process, e.g., correction of typographical
errors, changes of organizations name, etc.
7. How the revisions and retirement of the
SOPs will be handled.
8. Organizational aspects of the life cycle,
such as who develops, reviews, approves
and manages the SOPs.
The topics that should be considered when
outlining the use of SOPs should include such
matters as:
1. Distribution of SOPs and users access to
them.
2. Ensuring that only current versions of the
SOPs are accessible.

1 - DEVELOPMENT

1.1 DRAFT 1.2 REVIEW 1.3 1.4 ISSUE /

/ REVISE APPROVE IMPLEMENT

3.2
REVISE/
2 - USE
UPDATE (FOLLOW, MANAGE DEVIATIONS)
3.1
KEEP
AS IS

3 - PERIODIC REVIEW

4-
RETIRE

Figure 1. Overview of the SOP life cycle

Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2007; 11: 295301
DOI: 10.1002/qaj.427
GLP SOPs for Equipment Calibration and Maintenance
3. Following the SOPs and how to handle
deviations.
4. Implementation of SOPs, including train-
ing on their contents.
Some of the above items are rules that gov-
ern the procedures rather than the procedural
steps. This means that they can be covered, at
least in part, through policies rather than pro-
cedures. An example of such an item is the
duration of the review cycle.
Other topics, for example, the preferred
phraseology, may be best addressed through
guidelines.
SOP Contents
Further in this article, we will discuss some of
the details of SOP phraseology and formatting,
but regardless of how these are defined, there
are common SOP sections that should be
considered.
A typical SOP should include at least the
following sections:
 Purpose
 Scope
 Policies
 Responsibilities
 Procedures.
In addition, having the following sections in
the SOPs is always helpful:
 Equipment and Materials, for SOPs on
equipment and methods
 References
 Definitions
 Tools
 Attachments/Appendices
 Document History.
Maintaining consistent order of the sections
and requiring inclusion of all sections in each
SOP has the benefit that all SOPs have the same
feel, thus increasing user friendliness. In such
cases, template sections that are not applicable
Copyright r 2008 John Wiley & Sons, Ltd.
297
to an SOP may be marked with None, Not
applicable, N/A, etc.
To further improve the readability of the
SOPs, it is important to remain true to the
purpose of each section as detailed below, thus
helping to keep the readers focused on the key
thoughts.
Purpose
This is a very brief statement of the intent of the
SOP. It should not be confused with the Scope.
Scope
The Scope sets the boundaries for the applic-
ability of the SOP, to certain circumstances,
conditions, organizational units, etc. It is
important to set the scope within the real
control of the SOPs. Regardless of what the
SOP says, for example, it does not apply to
other departments or outside contractors.
There are times when it may be helpful to also
state what is excluded from the Scope. For
example, a general SOP on equipment main-
tenance may exclude instruments covered by
external service contracts.
Policies
This section contains key rules and/or con-
straints that apply to the process. It is in this
section that you would find statements such as
equipment must be used in accordance with
the manual. How the requirement is met, e.g.,
what manual and how, is described in the
Procedures section.
Responsibilities
The Responsibilities section provides a sum-
mary of key responsibilities of the participants
in the process. Listed below are some important
points to remember when creating this section:
 This is not a listing of the subtasks for which
a person is responsible, nor should it be
confused with the list of activities performed
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by an individual. Furthermore, only respon-
sibilities related to the SOP should be
described.
 In listing responsibilities associated with a
process, it is more practical to use functional
titles rather than personnel names and even job
titles as these may change faster than an SOP
can or needs to be updated. For example,
persons holding jobs of Scientist 1 through 3
may fulfill responsibilities of a Study Director.
 When assigning the responsibilities, make
sure that they are assigned to those who have
control over the matter. Often, the responsi-
bility is, by default, assigned to the person
who performs the required actions, regard-
less of that persons position. For example,
while the users may be required to check the
calibration status of an instrument, if only
the Laboratory Manager is allowed to do
anything about it, then that Manager, and
not the users, is the one responsible for
actually ensuring calibration.
 At the same time, take care not to assign
responsibilities to those over whom the SOP
has no control, e.g., outside the company or
outside the organizational group covered by
the SOPs. For example, a technician from a
vendor company may actually perform the
maintenance on a centrifuge. This means
that a customers SOP does not automati-
cally apply to the technician. Ensuring his or
her compliance may be done through a
contract that covers maintenance.
Procedures
This is where all the activities are described. It
is common to see in the Procedures section a lot
more than what was stated in the Purpose and
the Scope sections. Often such scope creep can
be traced to haphazard SOP development. It
occurs because each new SOP is being used to
address the gaps not yet covered by the
appropriate SOPs. In the long run it may be
best to leave the gaps so that it is easier to
maintain the mutual consistency of the differ-
ent SOPs.
Copyright r 2008 John Wiley & Sons, Ltd.
I. Colligon and M. Rosa
The Procedures section is where one sees the
most organization-to-organization variation in
appearance. Opinions vary widely about the
phrasing of the procedures and particularly
their ordering. In our experience, we have
found following logical or chronological order
to be most user-friendly. The activities to be
performed are frequently grouped by function.
One big disadvantage of such approach is that
while individuals can see in one place all they
need to do, it does not show the sequence of the
entire process. The other flaw of this method is
that is does not show the hand-offs and inter-
dependencies between process participants.
Another form often employed in describing
procedures is a flow diagram. There are numer-
ous ways to present flow diagrams, and some of
them were discussed in the previous installments
of this series [1,2]. One advantage of this method
is that it minimizes the need for reading and may
consequently reduce the time spent on learning
the process. This may be true for some in-
dividuals and it may also be helpful when
working in a multilingual environment where
readers command of the common language var-
ies, however a large segment of the population
learns better by reading. One compromise may
be to combine the two methods, either side by
side or as different sections of the document.
A tabulated presentation of the activities
sometimes helps to crystallize the ideas that
may be more difficult to express in complete
sentences. An example of such format is pre-
sented in Table 1.
Equipment and Materials
Often SOPs on equipment and methods also
include a section or subsection on Equipment
and Materials, similar to the Methods and
Materials sections in scientific papers and
reports.
References
It is a good practice to include a References or
Related Documents section. It can be used to
list related documents, such as manuals and
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GLP SOPs for Equipment Calibration and Maintenance
Table 1. Example of a tabulated procedure for developing instrument validation reports
Function/rolea First draft
Validation Scientist Draft &
circulate for
review
Users
Representatives Review & comment to
Lab Manager validation scientist
IS
QA
a
The roles in this column are created for illustration purposes and are in no way intended to represent a preferred or
recommended method of reviewing any reports.
applicable regulatory references. It is particu-
larly important to include such information in
the SOPs for equipment and methods.
Definitions
Having clear common definitions is essential to
ensuring compliance with the SOPs. The place-
ment of the definitions and their sources is
another topic of debate. Clearly, having con-
sistent definitions used throughout the SOPs is
important, and from the point of view of
logistics, having a separate Glossary is very
practical, guaranteeing such consistency. Un-
fortunately, placing all definitions in a single
location makes them less convenient when
reading individual SOPs. There are also times
when a relatively standard definition may need
to be modified to fit a specific case. One
approach that may work in this case is to
include in individual SOPs only the absolutely
necessary definitions.
When developing definitions, it is also ad-
visable to employ as many commonly used
terms and definitions as possible. Many of these
definitions may be found in regulatory
documents and from other commonly available
and referenced sources.
Tools
The intent of this section is to provide a
consolidated listing of the Tools (forms, tem-
plates, applications, etc.) associated with the
SOP. Some organizations that use electronic
Copyright r 2008 John Wiley & Sons, Ltd.
299
Interim
draft(s) Final draft Final report
Update & Finalize & Distribute
circulate for submit for archive
review approvals
Approve
Approve
document management systems for their SOPs
include in this section links to where the forms
may be found.
The dedicated Tools section is also useful in
ensuring that the users know what is required
to perform the tasks described.
It should be noted, however, that the life
cycle of the tools need not be linked to that of
the SOPs. For this reason, especially for tools
associated with multiple SOPs, it is best not to
include the actual tools in the SOPs. This also
helps prevent readers from using the included
form.
If a decision is made to include actual tools in
the SOPs, it is important to consider whether
this is being done to provide an easy-to-see
example or as a tool that will be managed in
parallel with the SOP. If illustration is the reason,
then it is best to clearly mark the tool as a sample
and to instruct users not to use it. This precau-
tion may help prevent audit findings, if the actual
tool is changed before the SOP is updated.
Attachments and Appendices
This is yet another section that may be used to
provide helpful illustrations, examples, etc. Its
inclusion is a matter of preference.
Document History
This section is used to document changes
that have been made during the lifetime of an
SOP. Tracking the evolution of an SOP is
a regulatory requirement. Some choose to
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300
incorporate the information into an SOP, and
others choose to maintain it as a separate
document.
SOP Template
In matters of grave importance, style, not
sincerity is the vital thing.
Oscar Wilde, The Importance of Being
Earnest
Having a layout and format for SOPs improves
their usability. Not having a standardized SOP
format creates an appearance of sloppiness and
lack of control, thus possibly casting doubt in
the eyes of auditors and inspectors on the
quality of the work performed according to
these documents.
Beyond what was discussed above, the ex-
tent to which the SOPs are standardized should
be based on the needs of each organization.
Care should be exercised, however, not to go
overboard by favoring form over function,
along the above quotation from Oscar Wilde. It
is common to find SOPs on SOPs describing in
great detail the layout of SOPs and even the
syntax and formatting of the text.
While there is some value in providing detailed
guidance, standardizing every detail may actu-
ally reduce the readability of the text. It is more
important to retain a consistent flow, with
standardized major headings and a clear un-
derstanding of what information belongs in
each section. Much of the other detail is better
provided in an SOP Style Guide.
Aspects of the SOP layout that need to be
standardized are:
 SOP numbering
 headers and footers
 pagination
 section headings
 section numbering
 text appearance (fonts, margins, etc.).
Beyond the layout, numerous schools of
thought exist on the sentence structure used for
Copyright r 2008 John Wiley & Sons, Ltd.
I. Colligon and M. Rosa
Table 2. Using standardized sentence struc-
ture
Option 1 Option 2
1. A performs Task 1 1. A performs Task 1, documents
results and submits results to B
2. A documents
results of Task 1
3. A submits results
to B
4. B receives results 2. After receiving the results from
from A A, B reviews results, documents
comments and sends comments
to A
5. B reviews results
from A
6. B documents
comments
7. B sends
comments to A
writing the procedures. Without doubt,
consistent sentence flow does have benefits.
On the other hand, over-standardizing sentences
may make them unmanageable or, worse,
hard to understand (see Table 2). In the end,
it is best to heed the advice of a very wise old
bear:
It is more fun to talk with someone who
doesnt use long, difficult words but rather
short, easy words like What about lunch?
Poohs Little Instruction Book, inspired by
A. A. Milne
Conclusion
So, what does it mean every organization should
have an SOP on SOPs? As we have discussed in
this installment, SOPs on SOPs should be an
integral part of every organizations SOP manage-
ment system. The SOP on SOPs defines the
foundation of the SOP life cycle. It also sets a
standard for SOPs. Without a consistent
and harmonized structure defined by the SOP
on SOPs, managing the lifecycles of all other
SOPs can be a challenge. Implementing and
documenting a solid process will help meet this
challenge.
Qual Assur J 2007; 11: 295301
DOI: 10.1002/qaj.427
GLP SOPs for Equipment Calibration and Maintenance
References
1. Rosa M, Colligon I. GLP SOPs for equipment
calibration and maintenance, part 2: an organized
approach to streamlining procedural documenta-
tion. Qual Assur J 2006; 10(3): 203207.
Copyright r 2008 John Wiley & Sons, Ltd.
301
2. Colligon I, Rosa M. GLP SOPs for equipment
calibration and maintenance, part 3: process map-
ping for SOP development. Qual Assur J 2006; 10(4):
279285.
Qual Assur J 2007; 11: 295301
DOI: 10.1002/qaj.427