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. This document is designed to provide guidance in the preparation and use of an SOP within a quality system.
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.
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.
4.0 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.
5.0 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.
6.0 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.
7.0 SOP Format
All SOPs have been uniformally designed and formatted. Information common to all SOPs is described below.
Different point to be follow during SOP writing:
_ SOP Format
_ SOP Number
_ SOP Title
_ Checked by
_ Approved by
_ Reasons For Revision
7.1 Descriptions of different inputs:
7.1 Descriptions of different inputs:
7.1.1 Company Name — At the top of each SOP, a box is provided to enter your company name.
7.1.2 SOP Number — Each SOP is assigned a unique number that appears at the upper-left corner of each page.
7.1.3 Title — The title of each SOP appears at the top of the first two pages below the SOP number. The title describes the subject of the SOP.
7.1.4 Date — Each SOP is assigned an effective date at the top of the page, to the right of the SOP number. The date describes the month, day, and year of implementation.
7.1.5 Author — Each SOP is assigned a space to provide the author name, title, and the department, along with signatures and dates.
7.1.6 Checked by — Each SOP is assigned a space to provide the name, title, and the department of the person responsible for checking the contents of the SOP requiring the signature and date.
7.1.7 Approved By — Each page of the SOP provides a space for the signature of the quality assurance or manager approving the SOP to prevent unauthorized changes.
7.1.8 Revisions — At the end of each page is the revisions box. This box documents the revision number, section, pages, initials, and date.
7.1.9 Subject/Title — Each SOP begins with the subject to provide key description of the SOP.
7.1.10 Purpose/Objective — Each SOP is supported with reasons, describing the purpose.
7.1.11 Scope — Scope of each SOP to be define.
7.1.12 Responsibility — The space for responsibility clearly identifies who has to follow the procedures and who is responsible for the overall compliance with the SOP.
7.1.13 Accountability: Accountability defines that department head responsible for implementation of SOP
7.1.14 Distribution: Distribution defines list of location (QA office/production floor/documentation cell) where SOP being kept or distributed.
7.1.15 Reference: Details of reference to be provided.
7.1.16 Attachment: Details of attachment to be mention, like data sheet recording or other format.
7.1.17 Material & Equipment: Mention material and equipment detail.
7.1.18 Procedure — Following the purpose statement are the individual steps of the SOP, arranged in logical order to make the SOP easy to perform.
7.1.19 Recording: Record keeping frequency and procedure to be maintain.
7.1.20 Abbreviation: List of abbreviation to be provided.7.1.21 Reason for Revision — At the end of each SOP, a space is provided to list the reasons why the SOP is changed, along with the date.
For reference see the below figure: