U.S.

Army Public Health Command (Provisional)

Technical Guide 176

Writing and Managing a

Standing Operating Procedure

Approved for public release; distribution unlimited

October 2010
Use of trademark name(s) does not imply endorsement by the U.S. Army but is
intended only to assist in the identification of a specific product.
USAPHC (Prov) TG No. 176 October 2010

TABLE OF CONTENTS

Page

1. Purpose ...................................................................................................................1

2. Definition .................................................................................................................. 1

3. Use .......................................................................................................................... 1

4. Developing and Publishing an SOP ......................................................................... 2

5. Structuring an SOP .................................................................................................. 2

6. Filing an SOP ........................................................................................................... 4

7. Maintaining a Historical Registry for Laboratory Procedures ................................... 4

8. Revising an SOP...................................................................................................... 4

9. Managing an SOP.................................................................................................... 5
USAPHC (Prov) TG No. 176 October 2010

WRITING AND MANAGING A STANDING OPERATING PROCEDURE

1. Purpose. Technical Guide (TG) 176 is for the person(s) who must plan, write, revise,
publish, or manage Standing Operating Procedure’s (SOPs). The guidance is
presented generically so that it can be used in any setting, such as administrative,
industrial, laboratory, or field operations. This guide addresses both the format and
content of administrative and technical SOPs.

2. Definition. An SOP is a clearly written set of instructions or methods detailing the

procedures for carrying out a routine or recurring task or study. The use of SOPs
describes both administrative and technical tasks.

3. Use.

a. As a management tool, an SOP—

(1) Provides a foundation for training new employees by establishing operational

procedures.

(2) Serves as a continuity tool in cases where regular personnel are absent from
an operation, enabling others to carry out the function.

(3) Refreshes the memory of management and experienced employees

regarding operational procedures within the organization.

(4) Helps maintain quality control by providing detailed, step-by-step guidance to

personnel who are required to carry out certain procedures.

(5) Sets forth study methods that are adequate to ensure the quality and integrity
of the data generated in the course of a study.

(6) Provides a documented, historical record of an organization's operating

procedures during a specific time period.

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USAPHC (Prov) TG No. 176 October 2010

b. As an administrative tool, an SOP can be used to—

(1) Decide where in an organization a procedure should be carried out.

(2) Decide what material and personnel resources are required.

(3) Outline the manner in which procedures are to be carried out.

4. Developing and Publishing an SOP.

a. Review your procedures and decide what needs to be explained in your SOP.
Seek the input of personnel who have experience in these procedures.

b. Gather information on the procedures from reference sources. Contact other

organizations performing similar functions to see if they have an SOP. If they do,
request a copy to use as a guide or source of ideas. Often, such a document can be
modified to serve your needs.

c. Assemble all blank forms and other documents you will need to reference in the
SOP.

d. Assign the SOP a number and title for identification and reference purposes.

e. Write a draft of the SOP, following the guidelines in paragraph 5.

f. Review the draft SOP for technical adequacy and administrative accuracy. Make
sure that the SOP conveys its message clearly, and that it answers the questions "who,"
"what," "when," "where," and "how."

g. Submit the draft SOP for peer review and supervisory approval.

h. Incorporate approved changes into a final version.

i. Sign and date the final version; include supervisors signature. On approval,
distribute copies as appropriate, and post a copy in the SOP file for reference (see
paragraph 6).

5. Structuring the SOP.

a. Format.

(1) Figure 1 shows the suggested format for an administrative SOP.

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USAPHC (Prov) TG No. 176 October 2010

(2) Figure 2 shows the suggested format for a technical SOP.

b. Numbering the divisions and parts of an SOP. The divisions of an SOP (such as
paragraphs, sections, and chapters) and certain parts (figures and tables) are numbered
to help make referencing easier. Table 1 explains the numbering scheme.

c. Table of Contents.

(1) If the SOP is over 10 paragraphs, include a table of contents.

(2) In preparing the table of contents, list part, chapter, section, paragraph titles
(if appropriate), and appendixes exactly as given in the body of the text and in the same
order.

d. Content.

(1) Be clear, concise, and thorough when listing the step-by-step procedures.
Remember that the person most dependent on your SOP is the employee who may
have little or no experience with the procedure in question. Technical phrases requiring
special knowledge should be avoided except when no other word or phrase will convey
the proper meaning. To better appreciate what you must communicate, place yourself
in the position of the employee that will be performing the tasks. Your greatest enemies
are vagueness and imprecision. Your SOP will be of little use if no one can understand
who is supposed to do what.

(2) Include only those steps that are carried out by the employees in the
immediate organization. When procedures include interactions with individuals outside
of the organization, indicate this but do not specify the actual steps taken by the other
persons.

(3) Be comprehensive in terms of how to get the procedure accomplished, but do

not encompass irrelevant matters.
.
(4) Be positive in your presentation.

e. Appendices. Include appendices when it is necessary to finish additional or

supplemental material (for example, reproduction of an agreement or a sample contract,
list of references, sample plan for a maneuver or exercise). Appendices, if used, are
placed at the end of the document.

f. Glossary. Provide a glossary if the SOP contains more than 15 abbreviations or

terms.

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USAPHC (Prov) TG No. 176 October 2010

g. Illustrations. Use illustrations only when they are essential, contribute to a clearer
understanding of the subject matter, or substantially reduce the narrative portion of the
SOP.

6. Filing the SOPs. When a number of SOPs have accumulated in a file, incorporate
them into an SOP Manual.

a. Place the individual SOPs into a large binder, sorting the documents into chapters
by subject.

b. Arrange these chapters in a logical sequence (for example, all administrative

procedures in one section and all laboratory procedures in another).

c. Develop a table of contents, and place it in the front of the binder.

d. Place the manual alongside other references such as Regulations and

Pamphlets.

7. Maintaining a Historical Registry for Laboratory Procedures. The supervisor must

maintain a historical file of obsolete laboratory SOPS and revisions according to Title
21, Code of Federal Regulations (CFR), Section 58.81, Standard Operating
Procedures, and Title 40, CFR, Section 160.81, Standard Operating Procedures.

a. File at least one copy of all discontinued or obsolete SOPS, (perhaps in a binder
stored near the SOP Manual).

b. Record the following information and attach it to the SOP cover—

This SOP was in effect for the period XX Month 20XX (original effective
date) through XX Month 20XX (date SOP was removed from service).
This SOP was replaced by SOP_____ (give the SOP number, effective
date, and title of the new SOP).

8. Revising the SOPs. The supervisor should review the SOPs, at least annually, to
ensure the procedures are current and accurately reflect changes in the work
environment.

a. If no changes are necessary, the reviewing supervisor should sign and date a
cover sheet and attach it to the file copy of the SOP. Figure 3 shows an example of a
cover sheet.

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USAPHC (Prov) TG No. 176 October 2010

b. If procedures change, rewrite the section.

(1) New material added by a change is identified by an asterisk.

(2) On rescinding a paragraph, delete the body of the paragraph but keep its
number and title in its original place in the text. Mark the paragraph with an asterisk and
write "rescinded" in parentheses after the title. The paragraph should appear in the text
as follows:

3-1 Requisitioning (Rescinded)

(3) In any future change, keep the number, the title, and “(Rescinded),” but
remove the asterisk. The number and title are not deleted until the publication is
revised.

(4) Prepare a memorandum to transmit the revised SOP to the user. Indicate the
number of changes and the number of changed pages. Attach the memorandum to the
file copy of the SOP.

c. If changes are extensive, revise the entire SOP, and follow steps addressed in
paragraphs 4g through 4i.

9. Managing the SOPs. One person in your organization should-

a. Assign SOP numbers for identification purposes.

b. Know how many copies of SOPs exist for good control, management, and
revision.

c. Verify that all organization SOPs—

(1) Are evaluated for currency at least annually.

(2) Contain cover sheets to reflect the supervisor's review

(see paragraph 8).

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USAPHC (Prov) TG No. 176 October 2010

NAME OF ORGANIZATION
(e.g., Division/Branch/Office)

(Office File Symbol)

SOP No._____________
Effective Date _____________
Date Removed from Service _____________

Title of SOP

1. Purpose. A brief statement which outlines the reason for or purpose of the SOP, described in
terms of function, applicability, and objective.

2. Authority. References the regulation that calls for procedure to be performed.

3. Abbreviations and Terms: Use a glossary if there are more than 5 terms or more than 15
abbreviations to be explained in the SOP. Otherwise, define them as they are introduced.

4. Procedure.

a. Procedures are an orderly series of specific actions taken to carry out an assignment (the
main contents of the body of the SOP)…

b. Subheadings a-z are used to break a procedure into sub procedures or

major components.

5. Safety Considerations. Include in all SOPs. If none, state that safety was a consideration.

6. References. List other publications that are cited in the text. All such publications must be
available to the user of the SOP.

Figure 1. Sample Format for an Administrative SOP

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USAPHC (Prov) TG No. 176 October 2010

NAME OF ORGANIZATION
(e.g., Division/Branch/Office)

(Office File Symbol)

SOP No.___________
Effective Date ___________
Date Removed from Service ___________

Title of SOP
1. Purpose. Is a brief statement which outlines the reason or purpose of the SOP. It
describes terms of function, applicability, and the objective.

2. Authority. References the regulation that calls for the procedure to be performed.

3. Abbreviations and Terms. Uses a glossary if there are more than 5 terms or 15
abbreviations to be explained in the SOP. Otherwise, define them as they are introduced.

4. Restrictions. Indicates who has authority to update the SOP and when.

5. Location. Indicates the area in which the procedures are to be followed, usually a lab
name and room number, or a location.

6. Scope. Describes the type of test, the nature of samples (matrix), and the type of program
supported. Include linear range, level of quantization (method detection limit), and method of
derivation and bias.

7. Sample Handling and Preservation. Focuses the analyst's responsibilities in sample

handling.

8. Apparatus and Materials. Describes reagents, standards and equipment used.

9. Analytical Procedures. Describes interferences, preparation, and analysis.

10. Quality Control. Describes the quality control checks including type, frequency, evaluation
procedure, acceptance and rejection criteria, and corrective actions.

11. Data Analysis. Describes how raw data is recorded, calculations are made, and results
are reported.

12. Documentation. Describes the information which shall be recorded sufficient to permit
data validation.

13. Report Requirements. Describes the information to be included in the final report.

14. Safety Considerations. Include in all SOPs. If there is none, state that safety was a
consideration.

15. References. List publications that are cited in the text; all such publications must be
available to the user of the SOP.

Figure 2. Sample Format for a Technical SOP

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 USAPHC (Prov) TG No. 176 October 2010

Table 1. Numbering the Divisions and Parts of a Publication

1. Parts Number consecutively, spelling out the part number. For
example, Part One, Part Two.
2. Chapters Number consecutively throughout the publication, using Arabic
numbers. For example, Chapter 1 or Chapter 2.
3. Sections Number consecutively within chapters, using capital Roman
numerals. For example, within Chapter 1, Section I, Section II;
within Chapter 2, Section I, Section II.
4. Paragraphsa Number consecutively, using two-part Arabic numbers. The first
number represent the chapter; the second the numerical
sequence of the paragraph within the chapter. For example. 1-
1, 1-2; 2-1, 2-2.
5. Subparagraphs First level: Number consecutively within each paragraph, using
lower-case letters in alphabetical sequence. For example, a,b,
c…z. aa, ab, ac ... az. ba, bb… bz.
Second level: Number consecutively within each subparagraph,
using Arabic numbers in parentheses. For example, within
subparagraph a, (11, (2)); within subparagraph b (111, (2)).
Third levelb number consecutively within each subparagraph,
using lower-case letters in parentheses, in alphabetical
sequence. For example, within subparagraph d(l), (a), (b); within
subparagraph a(2), (a), (b).
6. Illustrations and tables Number consecutively within each chapter, using two-part Arabic
numbers. The first number represents the chapter; the second,
the numerical sequence of the illustration or table within the
chapter. For example, Figure 1-1, Figure 1-2, Figure 2-1, Figure
2-2; Table 1-1, Table 1-2, Table 2-1, Table 2-2.
7. Appendixes Number consecutively, using capital letters in alphabetical
sequence. For example, Appendix A, Appendix Bc
a. Sections within an appendix Number consecutively within each appendix as explained
in Item 3.
b. Paragraphs within an Number consecutively, using a capital letter and an Arabic
appendix number. The letter represents the appendix; the number, the
numerical sequence of the paragraph within the appendix. For
example, A-1, A-2, B-1, B-2.
c. Subparagraphs Same as in item 5.
d. Illustrations and tables Number consecutively, using a capital latter and an Arabic
number. The letter represents the appendix; the number, the
numerical sequence of the illustration or table in the appendix.
For example, Figure A-I, Figure A-2; Table A-I, Table A-2.
8. Glossary Unnumbered.
Notes:
a
This item refers only to paragraphs in the body of the publication. Paragraphs in the foreword and a
glossary are not numbered.
b
A paragraph may not be divided further than the third level.
c
If there is only one Appendix, call it "Appendix A."

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USAPHC (Prov) TG No. 176 October 2010

SOP No.___________
Effective Date___________
Date Removed from Service___________

SOP Title

______________________________ ____________
Submitted by Date

______________________________ ____________
Approved by Date

Reviewed by

_____________________________ ____________
Supervisor Date

_____________________________ ____________
Supervisor Date

_____________________________ ____________
Supervisor Date

_____________________________ ____________
Supervisor Date

_____________________________ ____________
Supervisor Date

_____________________________ ____________
Supervisor Date

_____________________________ ____________
Supervisor Date

_____________________________ ____________
Supervisor Date

Figure 3. Example of a Review Cover Sheet

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