Standard Operating Procedures Benefits TYPES ,TYPES OF SOPs

Standard Operating Procedures Benefits TYPES ,TYPES OF SOPs

SOPs may be written for any repetitive technical activity, as well as for any administrative or functional programmatic procedure, that is being followed within an organization. General guidance for preparing both technical and administrative SOPs follows and examples of each are located in the Appendix.

Guidelines for Technical SOP Text

Technical SOPs can be written for a wide variety of activities. Examples are SOPs instructing the user how to perform a specific analytical method to be followed in the laboratory or field (such as field testing using an immunoassay kit), or how to collect a sample in order to preserve the sample integrity and representativeness (such as collection of samples for future analysis of volatile organic compounds or trace metals), or how to conduct a bioassessment of a freshwater site. Technical SOPs are also needed to cover activities such as data processing and evaluation (including verification and validation), modeling, risk assessment, and auditing of equipment operation.

Citing published methods in SOPs is not always acceptable, because cited published methods may not contain pertinent information for conducting the procedure-in-house. Technical SOPs need to include the specific steps aimed at initiating, coordinating, and recording and/or reporting the results of the activity, and should be tailored only to that activity. Technical SOPs should fit within the framework presented here, but this format can be modified, reduced, or expanded as required. Examples of technical SOPs are located in the Appendices A, B, and C.

In general, technical SOPs will consist of five elements: Title page, Table of Contents, Procedures, Quality Assurance/Quality Control, and References:

1. Title Page.

2. Table of Contents .

3. Procedures :

 The following are topics that may be appropriate for inclusion in technical SOPs. Not all will apply to every procedure or work process being detailed.

a. Scope and Applicability (describing the purpose of the process or procedure and any organization or regulatory requirements, as well as any limits to the use of the procedure).
b. Summary of Method (briefly summarizing the procedure).
c. Definitions (identifying any acronyms, abbreviations, or specialized terms used).
d. Health & Safety Warnings (indicating operations that could result in personal injury or loss of life and explaining what will happen if the procedure is not followed or is followed incorrectly; listed here and at the critical steps in the procedure).
e. Cautions (indicating activities that could result in equipment damage, degradation of sample, or possible invalidation of results; listed here and at the critical steps in the procedure).
f. Interferences (describing any component of the process that may interfere with the accuracy of the final product).
g. Personnel Qualifications/Responsibilities (denoting the minimal experience the user should have to complete the task satisfactorily, and citing any applicable requirements, like certification or “inherently governmental function”).
h. Equipment and Supplies (listing and specifying, where necessary, equipment, materials, reagents, chemical standards, and biological specimens).
i. Procedure (identifying all pertinent steps, in order, and the materials needed to accomplish the procedure such as:
• Instrument or Method Calibration and Standardization
• Sample Collection
• Sample Handling and Preservation
• Sample Preparation and Analysis (such as extraction, digestion, analysis, identification, and counting procedures)
• Troubleshooting
• Data Acquisition, Calculations & Data Reduction Requirements (such as listing any mathematical steps to be followed)
• Computer Hardware & Software (used to store field sampling records, manipulate analytical results, and/or report data), and
j. Data and Records Management (e.g., identifying any calculations to be performed, forms to be used, reports to be written, and data and record storage information).

4. Quality Control and Quality Assurance Section :

 QC activities are designed to allow self-verification of the quality and consistency of the work. Describe the preparation of appropriate QC procedures (self-checks, such as calibrations, recounting, reidentification) and QC material (such as blanks - rinsate, trip, field, or method; replicates; splits; spikes; and performance evaluation samples) that are required to demonstrate successful performance of the method. Specific criteria for each should be included. Describe the frequency of required calibration and QC checks and discuss the rationale for decisions. Describe the limits/criteria for QC data/results and actions required when QC data exceed.
QC limits or appear in the warning zone. Describe the procedures for reporting QC data and results.

5. Reference Section :

Documents or procedures that interface with the SOP should be fully referenced (including version), such as related SOPs, published literature, or methods manuals. Citations cannot substitute for the description of the method being followed in the organization. Attach any that are not readily available.

Guidelines for Administrative or Fundamental Programmatic SOP Text

As with the technical SOPs, these SOPs can be written for a wide variety of activities, e.g., reviewing documentation such as contracts, QA Project Plans and Quality Management Plans; inspecting (auditing) the work of others; determining organizational training needs; developing information on records maintenance; validating data packages; or describing office correspondence procedures. Administrative SOPs need to include a number of specific steps aimed at initiating the activity, coordinating the activity, and recording and/or reporting the results of the activity, tailored to that activity. For example, audit or assessment SOPs should specify the authority for the assessment, how auditees are to be selected, what will be done with the results, and who is responsible for corrective action. Administrative SOPs should fit within the framework presented here, but this format can be modified, reduced, or expanded. An example of administrative SOPs can be found in Appendix E.

In general, administrative/programmatic SOPs will consist of five elements: Title page, Table of Contents, Purpose, Procedures, Quality Assurance/Quality Control, and References.

1. Title Page.

2. Table of Contents .

3. Procedures :

The following are topics that may be appropriate for inclusion in administrative SOPs:
a. Purpose – (identifying the intended use of the process).
b. Applicability/Scope (identifying when the procedure is to be followed).
c. Summary of Procedure.
d. Definitions (defining any words, phrases, or acronyms having special meaning or application).
e. Personnel Qualifications/Responsibilities (identifying any special qualifications users should have such as certification or training experience and/or any individual or positions having responsibility for the activity being described).
f. Procedure.
g. Criteria, checklists, or other standards that are to be applied during the procedure such as citing this document as guidance for reviewing SOPs).
h. Records Management (specifically, e.g., as forms to be used and locations of files).

4. Quality Control and Quality Assurance Section :

 Describe any control steps and provisions for review or oversight prior to acceptance of the product or deliverable. This can include test plans such as verification and validation plans for software or running a “spell-check” program on the finished document.

5. Reference Section :

 Cite all references noted in the body of the SOP. A copy of any cited references not readily available should be attached to the SOP.

Standard Operating Procedures Process, SOP Process, SOP Preparation,SOP Review and Approval, SOP Document Tracking and Archival

Standard Operating Procedures Process, SOP Process

SOP Preparation

The organization should have a procedure in place for determining what procedures or processes need to be documented. Those SOPs should then be written by individuals knowledgeable with the activity and the organization's internal structure. These individuals are essentially subject-matter experts who actually perform the work or use the process. A team approach can be followed, especially for multi-tasked processes where the experiences of a number of individuals are critical, which also promotes “buy-in” from potential users of the SOP.

SOPs should be written with sufficient detail so that someone with limited experience with or knowledge of the procedure, but with a basic understanding, can successfully reproduce the procedure when unsupervised. The experience requirement for performing an activity should be noted in the section on personnel qualifications. For example, if a basic chemistry or biological course experience or additional training is required that requirement should be indicated.

SOP Review and Approval

SOPs should be reviewed (that is, validated) by one or more individuals with appropriate training and experience with the process. It is especially helpful if draft SOPs are actually tested by individuals other than the original writer before the SOPs are finalized.

The finalized SOPs should be approved as described in the organization’s Quality Management Plan or its own SOP for preparation of SOPs. Generally the immediate supervisor, such as a section or branch chief, and the organization’s quality assurance officer review and approve each SOP.

Signature approval indicates that an SOP has been both reviewed and approved by management. As per the Government Paperwork Elimination Act of 1998, use of electronic signatures, as well as electronic maintenance and submission, is an acceptable substitution for paper, when practical.

Frequency of Revisions and Reviews

SOPs need to remain current to be useful. Therefore, whenever procedures are changed, SOPs should be updated and re-approved. If desired, modify only the pertinent section of an SOP and indicate the change date/revision number for that section in the Table of Contents and the document control notation.

SOPs should be also systematically reviewed on a periodic basis, e.g. every 1-2 years, to ensure that the policies and procedures remain current and appropriate, or to determine whether the SOPs are even needed. The review date should be added to each SOP that has been reviewed. If an SOP describes a process that is no longer followed, it should be withdrawn from the current file and archived.

The review process should not be overly cumbersome to encourage timely review. The frequency of review should be indicated by management in the organization’s Quality Management Plan. That plan should also indicate the individual(s) responsible for ensuring that SOPs are current.

Checklists

Many activities use checklists to ensure that steps are followed in order. Checklists are also used to document completed actions. Any checklists or forms included as part of an activity should be referenced at the points in the procedure where they are to be used and then attached to the SOP.

In some cases, detailed checklists are prepared specifically for a given activity. In those cases, the SOP should describe, at least generally, how the checklist is to be prepared, or on what it is to be based. Copies of specific checklists should be then maintained in the file with the activity results and/or with the SOP.
Remember that the checklist is not the SOP, but a part of the SOP.

Document Control

Each organization should develop a numbering system to systematically identify and label their SOPs, and the document control should be described in its Quality Management Plan. Generally, each page of an SOP should have control documentation notation, similar to that illustrated below. A short title and identification (ID) number can serve as a reference designation.

The revision number and date are very useful in identifying the SOP in use when reviewing historical data and is critical when the need for evidentiary records is involved and when the activity is being reviewed. When the number of pages is indicated, the user can quickly check if the SOP is complete.

Generally this type of document control notation is located in the upper right-hand corner of each document page following the title page.
Short Title/ID #
Rev. #:
Date:

SOP Document Tracking and Archival

The organization should maintain a master list of all SOPs. This file or database should indicate the SOP number, version number, date of issuance, title, author, status, organizational division, branch, section, and any historical information regarding past versions. The QA Manager (or designee) is generally the individual responsible for maintaining a file listing all current quality-related SOPs used within the organization. If an electronic database is used, automatic “Review SOP” notices can be sent. Note that this list may be used also when audits are being considered or when questions are raised as to practices being followed within the organization.

As noted above , the Quality Management Plan should indicate the individual(s) responsible for assuring that only the current version is used. That plan should also designated where, and how, outdated versions are to be maintained or archived in a manner to prevent their continued use, as well as to be available for historical data review.

Electronic storage and retrieval mechanisms are usually easier to access than a hard-copy document format. For the user, electronic access can be limited to a read-only format, thereby protecting against unauthorized changes made to the document.

Standard Operating Procedures Frequency of Revisions and Reviews, SOP Process

Standard Operating Procedures Frequency of Revisions and Reviews, SOP Process

SOPs need to remain current to be useful. Therefore, whenever procedures are changed, SOPs should be updated and re-approved. If desired, modify only the pertinent section of an SOP and indicate the change date/revision number for that section in the Table of Contents and the document control notation.

SOPs should be also systematically reviewed on a periodic basis, e.g. every 1-2 years, to ensure that the policies and procedures remain current and appropriate, or to determine whether the SOPs are even needed. The review date should be added to each SOP that has been reviewed. If an SOP describes a process that is no longer followed, it should be withdrawn from the current file and archived.

The review process should not be overly cumbersome to encourage timely review. The frequency of review should be indicated by management in the organization’s Quality Management Plan. That plan should also indicate the individual(s) responsible for ensuring that SOPs are current.

Standard Operating Procedures Review and Approval, SOP Process

Standard Operating Procedures Review and Approval, SOP Process

SOPs should be reviewed (that is, validated) by one or more individuals with appropriate training and experience with the process. It is especially helpful if draft SOPs are actually tested by individuals other than the original writer before the SOPs are finalized.

The finalized SOPs should be approved as described in the organization’s Quality Management Plan or its own SOP for preparation of SOPs. Generally the immediate supervisor, such as a section or branch chief, and the organization’s quality assurance officer review and approve each SOP. Signature approval indicates that an SOP has been both reviewed and approved by management. As per the Government Paperwork Elimination Act of 1998, use of electronic signatures, as well as electronic maintenance and submission, is an acceptable substitution for paper, when practical.

Standard Operating Procedures Preparation , SOP PROCESS

Standard Operating Procedures Preparation , SOP PROCESS

The organization should have a procedure in place for determining what procedures or processes need to be documented. Those SOPs should then be written by individuals knowledgeable with the activity and the organization's internal structure. These individuals are essentially subject-matter experts who actually perform the work or use the process. A team approach can be followed, especially for multi-tasked processes where the experiences of a number of individuals are critical, which also promotes “buy-in” from potential users of the SOP.

SOPs should be written with sufficient detail so that someone with limited experience with or knowledge of the procedure, but with a basic understanding, can successfully reproduce the procedure when unsupervised. The experience requirement for performing an activity should be noted in the section on personnel qualifications. For example, if a basic chemistry or biological course experience or additional training is required that requirement should be indicated.

Standard Operating Procedures Writing Styles

Standard Operating Procedures Writing Styles

SOPs should be written in a concise, step-by-step, easy-to-read format. The information presented should be unambiguous and not overly complicated. The active voice and present verb tense should be used. The term "you" should not be used, but implied. The document should not be wordy, redundant, or overly lengthy. Keep it simple and short. Information should be conveyed clearly and explicitly to remove any doubt as to what is required. Also, use a flow chart to illustrate the process being described. In addition, follow the style guide used by your organization, e.g., font size and margins.

Examples of Standard Operating Procedure, Standard Operating Procedure Examples

Examples of Standard Operating Procedure, Standard Operating Procedure Examples

The easiest way to write standard operating procedures is to see how others do it.

See how different organizations write, format, and design their own SOP.

Here is the list:

1. Two examples of various categories of SOPs are given in the ensuing chapters.
www.fao.org/docrep/w7295e/w7295e04.htm

2. Biotechnology Program, Montgomery College – SOP
Sample Standard Operating Procedures. SOP. Formats. Doc. PDF (Requires Acrobat Reader ).
www.montgomerycollege.edu/Departments/biotechnology/sop.html

3. Safety Training Resources
www.ehs.uci.edu/programs/sop_library

4. Emergency Management Program Standard Operating Procedure (SOP)
www.pandemicflu.va.gov/

5. Employee Training and Development
http://www.feedforward.com.au/sop_training.htm

6. Developing Effective Standard Operating Procedures
www.ansci.cornell.edu/pdfs/sopsdir.pdf