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

Standard Operating Procedures Benefits

Standard Operating Procedures Benefits

The development and use of SOPs minimizes variation and promotes quality through consistent implementation of a process or procedure within the organization, even if there are temporary or permanent personnel changes. SOPs can indicate compliance with organizational and governmental requirements and can be used as a part of a personnel training program, since they should provide detailed work instructions.

It minimizes opportunities for miscommunication and can address safety concerns. When historical data are being evaluated for current use, SOPs can also be valuable for reconstructing project activities when no other references are available. In addition, SOPs are frequently used as checklists by inspectors when auditing procedures. Ultimately, the benefits of a valid SOP are reduced work effort, along with improved comparability, credibility, and legal defensibility.

SOPs are needed even when published methods are being utilized. For example, if an SOP is written for a standard analytical method, the SOP should specify the procedures to be followed in greater detail than appear in the published method. It also should detail how, if at all, the SOP differs from the standard method and any options that this organization follows. As noted in ASTM D5172-91 (2004), Standard Guide for Documenting the Standard Operating Procedures Used for the Analysis of Water, “a significant part of the variability of results generated by different laboratories analyzing the same samples and citing the same general reference is due to differences in the way the analytical test methods and procedures are actually performed in each laboratory. These differences are often caused by the slight changes or adjustments allowed by the general reference, but that can affect the final results." Using a correct well-written SOP can minimize such differences.

Standard Operating Procedures GENERAL FORMAT ,,SOP GENERAL FORMAT

Standard Operating Procedures GENERAL FORMAT ,SOP GENERAL FORMAT

SOPs should be organized to ensure ease and efficiency in use and to be specific to the organization which develops it. There is no one “correct” format; and internal formatting will vary with each organization and with the type of SOP being written. Where possible break the information into a series of logical steps to avoid a long list. The level of detail provided in the SOP may differ based on, e.g., whether the process is critical, the frequency of that procedure being followed, the number of people who will use the SOP, and where training is not routinely available. A generalized format is discussed next.

Title Page

The first page or cover page of each SOP should contain the following information: a title that clearly identifies the activity or procedure, an SOP identification (ID) number, date of issue and/or revision, the name of the applicable agency, division, and/or branch to which this SOP applies, and the signatures and signature dates of those individuals who prepared and approved the SOP. Electronic signatures are acceptable for SOPs maintained on a computerized database.

Table of Contents

A Table of Contents may be needed for quick reference, especially if the SOP is long, for locating information and to denote changes or revisions made only to certain sections of an SOP.

Text

Well-written SOPs should first briefly describe the purpose of the work or process, including any regulatory information or standards that are appropriate to the SOP process, and the scope to indicate what is covered.

Define any specialized or unusual terms either in a separate definition section or in the appropriate discussion section. Denote what sequential procedures should be followed, divided into significant sections; e.g., possible interferences, equipment needed, personnel qualifications, and safety considerations (preferably listed in bold to capture the attention of the user).

 Finally, describe next all appropriate QA and quality control (QC) activities for that procedure, and list any cited or significant references.

As noted above, SOPs should be clearly worded so as to be readily understandable by a person knowledgeable with the general concept of the procedure, and the procedures should be written in a format that clearly describes the steps in order. Use of diagrams and flow charts help to break up long sections of text and to briefly summarize a series of steps for the reader.

Attach any appropriate information, e.g., an SOP may reference other SOPs. In such a case, the following should be included:
1. Cite the other SOP and attach a copy, or reference where it may be easily located.
2. If the referenced SOP is not to be followed exactly, the required modification should be specified in the SOP at the section where the other SOP is cited.

STANDARD OPERATING PROCEDURES Purpose

STANDARD OPERATING PROCEDURES Purpose

SOPs detail the regularly recurring work processes that are to be conducted or followed within an organization. They document the way activities are to be performed to facilitate consistent conformance to technical and quality system requirements and to support data quality. They may describe, for example, fundamental programmatic actions and technical actions such as analytical processes, and processes for maintaining, calibrating, and using equipment. SOPs are intended to be specific to the organization or facility whose activities are described and assist that organization to maintain their quality control and quality assurance processes and ensure compliance with governmental regulations.

If not written correctly, SOPs are of limited value. In addition, the best written SOPs will fail if they are not followed. Therefore, the use of SOPs needs to be reviewed and re-enforced by management, preferably the direct supervisor. Current copies of the SOPs also need to be readily accessible for reference in the work areas of those individuals actually performing the activity, either in hard copy or electronic format, otherwise SOPs serve little purpose.

Standard Operating Procedures Overview

Standard Operating Procedures Overview

A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. The development and use of SOPs are an integral part of a successful quality system as it provides individuals with the information to perform a job properly, and facilitates consistency in the quality and integrity of a product or end-result. The term “SOP” may not always be appropriate and terms such as protocols, instructions, worksheets, and laboratory operating procedures may also be used. For this document “SOP” will be used.

SOPs describe both technical and fundamental programmatic operational elements of an organization that would be managed under a work plan or a Quality Assurance (QA) Project Plan [EPA Requirements for QA Project Plans (QA/R-5) (EPA 2001a)], or Chapter 5 of the EPA Quality Manual for Environmental Programs, (EPA Manual 5360 A) and under an organization’s Quality Management Plan [EPA Requirements for Quality Management Plans (QA/R-2) (EPA 2001b)], or Chapter 3 of the EPA Quality Manual. This document is designed to provide guidance in the preparation and use of an SOP within a quality system.

How to write SOP,How to Write a Standard Operating Procedure

A Standard Operating Procedure, or an "SOP" is a document containing instructions on how to perform a task. It ensures that routine jobs get performed safely and in compliance with applicable regulations. You can write an authoritative Standard Operating Procedure by following these steps.

Instructions

1. • 1
     Ask employees using the SOP for their input on how the job should be performed. Expect the document to undergo several drafts before a final can be generated. Have the employees themselves review the drafts for additional suggestions.
   • 2
     Prepare a first draft. This draft should map out all necessary steps in the procedure. Determine if any large steps can be broken down into smaller steps. Create a simple flow chart to serve as a valuable first draft.
   • 3
     Write the first page including a short introduction giving an overview of the entire job. This way, employees who normally read and perform one step at a time must preview the job from start to finish before beginning.
   • 4
     Prepare a header on the first page. It must include the company name and business unit logo, document title, date of creation and specific document number as assigned by document control personnel. Also include an issue number generated by change control.
   • 5
     Create a table directly under the header entitled, "Amendment History and Approvals." Include columns for the issue date of the SOP, description of changes and signatures for the SOP originator, department manager and the Quality Control manager. The description of changes briefly should summarize any revisions made to the SOP since its creation. Each revision must be signed by its initiator.
   • 6
     Begin the second page with the purpose of the SOP. Include its scope, the contents of the document, definitions of terms or abbreviations used in the SOP, responsibilities of personnel involved in the procedure and references to documents the SOP relied upon, such as trade standards.
   • 7
     Finish the SOP by describing the procedure in short steps. Use simple language and avoid describing multiple steps in the same sentence. Once the task has been detailed, date the document and have it signed by the appropriate regulatory personnel. Email the SOP to the document control department and the manager responsible for implementing the procedure.

How to write SOP,How to Write a Standard Operating Procedure

Read more: How to Write a Standard Operating Procedure | eHow.com http://www.ehow.com/how_2096579_write-standard-operating-procedure.html#ixzz1LqB7sgxN

8 Steps to Writing an SOP ,Steps to Writing an SOP

8 Steps to Writing an SOP ,Steps to Writing an SOP

The SOP development process is an excellent way for managers, workers, and technical advisers to cooperate for everyone’s benefit. Standard operating procedures used in combination with planned training and regular performance feedback lead to an effective and motivated workforce.
The following eight steps describe a method that will produce excellent procedures and generate maximum buy-in from the workforce.


1. Plan for Results
Standard operating procedures work best when they are designed to achieve specific results. Decide what business goals will be achieved through better management with SOPs and how those goals will be measured. Many benchmarks exist in the industry to help measure quality and efficiency in specific areas.

2. Produce First Draft
Select a format for the procedure. If you choose to use simple steps, hierarchical steps, or the graphic format, first make a detailed list of the steps in the order that they are done. A simple way to get started is to observe someone performing the process as it now exists and write down everything that the person does. This list is now a draft of the procedure. If the procedure needs to appear as a flowchart, start with the most reasonable beginning point. Draw the decisions that a worker will need to make and the actions that follow each decision. Don’t try to be perfect with the first draft, because it is very likely that you will need to make many revisions.

3. Conduct Internal Review
Provide each worker who performs the procedure with a copy of the draft SOP. Ask the workers to review and suggest changes that will make the procedure easier to understand or more accurate or will improve performance. Assure the workers that their input is important and will be used. People are much more likely to accept and use an SOP if they feel a sense of ownership in it. Another reason to involve the workers is that they are likely to have good ideas. Highly successful managers actively engage their work teams in a continual quest to become more efficient, increase cost-effectiveness, and improve quality.

4. Conduct External Review
Managers increasingly rely on advisers outside their own organizations. The SOP writing process is an excellent way to tap the expertise of your advisers. Provide them with a copy of the SOP draft. Ask them to suggest any changes that will make it clearer and more effective. Revise the procedure as necessary to incorporate their input.

5. Test
For procedures to be effective, they must perform in the workplace. There is only one way to be absolutely certain that a procedure is well written and performs as expected. Have someone test the procedure by performing each step exactly as it is described while the procedure writer watches. Have a person not familiar with the work follow the procedure. Any steps that cause confusion or hesitation for the test worker should be revised.

6. Post
Make a final draft of the procedure and post it in the appropriate locations. The workplace is one essential location. A master SOP file should be kept in a central location so workers can review little-used SOPs when necessary. It is essential to keep SOPs up to date.

7. Train
One of the last steps in the SOP writing process is often the most neglected. Train or retrain everyone as necessary to follow the procedure exactly. Even with very detailed steps, it is necessary to train all workers. Otherwise, individuals will interpret the meaning of procedures in different ways, leading to inconsistency in work routines and performance.
An effective SOP training program first will make the worker aware of what training activities will take place and what the trainee will be able to do when training is complete. The trainer will explain and demonstrate both why and how each step in the SOP is performed and then give the learner a chance to practice. The trainer will provide positive feedback as the learner masters parts of the procedure and patiently revisits those parts that need improvement.

8. Audit
An audit will show whether the procedure is being adhered to and whether the objectives are being met. It can also help identify areas where improvements can be made. Each SOP should be audited about three months after implementation and thereafter at least annually. In addition, the SOP should be audited when dispensing errors or “near misses” occur, to identify ways of preventing their recurrence.

8 Steps to Writing an SOP ,Steps to Writing an SOP

SOP ,Standard Operating Procedures

Standard Operating Procedures (SOP)

Definition of SOP

Standard Operating Procedures, also known as SOPs, are created to provide specific documentation for various processes, usually highly-technical processes. Businesses are finding that they lack this kind of documentation; either there has been inadequate process definitions altogether, or they have no documentation in place. When reviewing the existing documentation, it is important to know where a particular SOP may be needed, or that the SOP available is too technical or not current for most users to be able to use.

Standard operation procedures, more commonly referred to as standard operating procedures, or SOP, are important business tools that create a professional environment that is consistent and predictable. Because of their role in business success, the ability to create, use and implement standard operating procedures can contribute to business success.

1. SOP Identification 

   • The Business Dictionary states that a standard operating procedure must be a written document that can be used as guidance any time a specific task or project is undertaken. It is a list of best practices that maximize the likelihood of the given task or project producing the desired results.
     Standard operating procedures are common in a number of different fields, including the military, health care and education.

   SOP Purpose 

   • Standard operating procedures have several purposes.
     First, they establish the roles and tools needed for a given task. Second, they provide a knowledge base for the business. Finally, they are a written record of the procedures, actions and policies that contribute to a project's success.

   SOP Structure

   • There are several parts of a standard operating procedure.
     The purpose of the procedure clearly states what a particular procedure should be used for and the expected results. The procedure outlines step by step what should take place in order to achieve the expected results.
     Standard operating procedures also usually contain a section with contact information for key players or experienced professionals who can field questions. They may also contain appendices or links with useful information.

   SOP Creation

   • A standard operating procedure is created to provide guidance for a specific task or project. The procedure should undergo internal and external review to ensure that it is as clear and useful as possible. The procedure is then tested, edited if necessary and made available to staff members.

   SOP Benefits

   • Encoding information in a standard operating procedure enables employees to do a better job by providing them with established, tested information that allows them to successfully complete a task. Combined with training and feedback, SOPs boost employee morale and effectiveness.