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.