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Proceedings of the 4th National Symposium on Biosafety

SOP Writing Workshop

Michael Mispagel, PhD
College of Veterinary Medicine
The University of Georgia
Athens, GA 30607-7411
706-542-5933

Most of us try to conduct our procedures in a consistent manner simply because we get better results that way or because that is how the "gizmo's" operating manual tells us to use it. Whether we like to admit it or not, we are using standard operating procedures (SOPs). They may not, however, be in a written form or formally approved by management. The purpose of this presentation is to convince you that written SOPs are in fact a good idea and to show you how to prepare an acceptable SOP.

Why have them and why write them?

There are at least six good reasons to use written standard operating procedures:

  1. The use of SOPs serves most importantly to standardize methods and procedures in order to prevent systematic errors in the collection and reporting of data.
  2. They serve as written reminders to the staff of the correct way of conducting a procedure.
  3. SOPs should be used as training tools for all new staff. A form should be used to indicate which SOPs have been read and understood by the employee, and when that took place. In addition, the same form can be used to "certify" by date and supervisor's initials that the employee is competent to perform the procedure as outlined in the SOP.
  4. SOPs also serve as a reminder to the staff of the correct steps to take when conducting an infrequent procedure.
  5. Writing an SOP forces the author to think through the procedure step by step and to modify those procedures if necessary.
  6. The use of written SOPs allows your facility to comply with federal regulations such as Good Laboratory Practice standards required by the EPA, FDA, and other federal agencies.

Despite the unarguable fact that SOPs are a nuisance to write and to keep track of, there are many benefits to using them:

  1. There is less likelihood that errors will occur if an SOP is followed for a given procedure, thus reducing the potential "cost" of discovering an error after-the-fact which may affect the integrity of the data.
  2. Use of SOPs will assure that all personnel perform a procedure in the same manner despite the previous experience of individuals in other labs, thus reducing the likelihood of system-wide errors.
  3. The use of SOPs will save time in the training of new personnel.

The Good Laboratory Practice standards (GLPs) promulgated by both the EPA at 40 CFR 160 and the FDA at 29 CFR 58 mandate the use of SOPs.

"A testing facility shall have standard operating procedures in writing setting forth study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study." [40 CFR 160.81]

The GLPs require that the SOPs be authorized by management and that an historical file of SOPs and all dated revisions be maintained. A number of specific SOPs are cited as required for studies conducted under the GLPs.

How to write SOPS

SOPs should be brief and succinct to assure that they will be read and frequently referenced. Use of an outline format is better than prose. Number each step in the procedure.

The individual(s) who actually conduct the procedure on a daily basis should be the ones to actually write the SOP since they are most familiar with the procedure. Colleagues of the author should use the new SOP to conduct the procedure to test its accuracy, completeness and ease of use. The author(s) should aim to be specific as to procedure, but general as to materials so that the SOP does not inadvertently limit you to one vendor, brand, or person who can perform the procedure.

What should be on the cover page of the SOP?

  1. Title
  2. SOP identification number: Numerical by department, building, project, category, etc. or whatever makes most sense in your particular situation
  3. Revision number as needed
  4. Approval signatures by the author and by management
  5. Date when in effect
  6. Paginated as "Page 1 of y"

Organization and format of the SOP

A number of items can and should be included in the SOP. The purpose and scope as well as the procedures themselves are required by the GLPs, the rest of th items are optional.

  1. Purpose and scope
  2. Materials and equipment needed, if appropriate
  3. Safety concerns, if appropriate
  4. Definitions
  5. Responsibilities of specific individuals, departments, etc.
  6. Step-by-step instructions on how to conduct the procedure
  7. Records to be kept
  8. Identification and emphasis of "critical steps" in procedure
  9. Copies of forms to be used, drawings of apparatus, tables, figures, etc.
  10. References, i.e. operating manuals, published techniques, other SOPs, etc.
  11. Use a header or footnote to identify the SOP number, revision number, and date on each page of the SOP.

Reviews and Revisions

Update and revise only those SOPs that need revision based on new techniques, new equipment, refinement of method, etc. A documented, annual review of all other SOPs is sufficient.

Distribution and Archiving

A copy of the SOP manual should be available at all work stations, not in a file cabinet or on a shelf in the supervisor's office. The SOPs are working documents and must be available to your staff for reference and use.

Depending on the size of your facility and the number of employees and project areas, it may be useful to maintain a distribution sheet for each SOP so that you know who received which set of SOPs. Clearly, not every staff member need be familiar with SOPs which do not pertain to their duties or obligations. The distribution list will become invaluable when it is time to review, revise, and re-issue SOPs.

The superceded SOPs should be returned to the issuing office for destruction after the original copy has been archived. An archive of old SOPs is mandated by the GLPs because during the reconstruction of a study, it is important to know which SOPs were in effect at a given time. Access to those old SOPs will help to explain how and why a specific procedure was conducted which produced the given results.

SOP No

Standard Operating Procedure

Title:

Initial Issuance

Author Management Approval/ Date Effective Date

 
 
 
 
 
 
 
 
 

Periodic Review

Reviewed by Date Approved by Management Date Changed?
(Y/N) 		Effective Date Revision Number
             
             
             
             
             
             
             
             
             
             
             

SOP # 305-EX
Page: 7 of 9
Revision # 2.0


AGRICULTURAL SERVICES LABORATORY

USDACooperative Extension Service
University of Georgia
Athens, GA 30605

SOP No. 305-EX (continued).. CERTIFICATE OF TRAINING* Employee:________________________

Activity Trained Certified
Date By Date By
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         
         

* This form format was supplied by Dr. Michael Mispagel, University of Georgia School of Veterinary Medicine.

Symposium Contents

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Last Modified: 1/2/97
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