Standard operating procedures (SOPs) are ubiquitous in the pharmaceutical realm. Every major organization utilizes them, as do many smaller organizations. These documents can be found in every department and applied to virtually any process. They are used to ensure a specific protocol is followed to ensure the same result (or at least one very similar) is achieved every time it is performed. In this respect, SOPs represent perhaps the most important of all administrative controls. For any process in the industry, risks to employees are significantly minimized when they are performed correctly and with good repeatability by all personnel.
Despite their firmly embedded nature in the industry, it is shocking how often an SOP is poorly written or structured. A bad SOP is a surefire way to have employees ignore it and seek their own method of implementing a process. When this happens, deviations are sure to follow. And not just deviations that the quality group would care about. When employees can’t interpret or follow an SOP and go rogue, the chances of an injury or exposure to harmful materials drastically increases. This post is intended to review the key aspects of a properly written SOP so that you apply them to your safety protocols.
What goes into an SOP?
There are no regulatory bodies which specify exactly how an SOP should be structured. However, the best SOPs have several common sections (NOTE: the sections do not necessarily have to appear in this order, and each organization can choose to mix and match placement within a document):
1. Header – the header is located at the top of document. It contains the title of the document, the document control number, the version number, and whether or not it is currently effective, in draft, superseded, etc.
2. Revision History – notes the changes that appear in the current version. These can include major and minor changes, or grammatical and procedural changes. Whatever the case may be, the rationale should be documented here.
3. Purpose – why the document was written. In terms of ISO 31000, this is the context of the document.
4. Scope – what exactly the document covers; that is, which processes, equipment, or personnel to whom the document applies. This section should be explicit and leave no room for interpretation.
5. Definitions – every SOP will have acronyms and jargon. This section should be used to define what those terms mean without ambiguity.
6. Roles and Responsibilities – specifically, who will be required to perform what action. It is not uncommon for an SOP to impact multiple parties from multiple departments. Clearly stating what must be done by each person is essential to the proper implementation of an SOP. Moreover, avoid the use of names in this section; rather, utilize job titles (this will reduce the need to update documents whenever attrition occurs).
7. Procedure – the heart of the document. The entire reason the document exists in the first place. This section must be written with clarity, each step explicitly stating what must (and must not) be done. Enough detail needs to be provided for repeatable execution, but not so much that it becomes a Tolstoy novel.
8. References – every SOP will make reference to another document. This section should succinctly list them. If the document being references is an internal document (e.g. another SOP), the reference should contain the internal document control number. If it is an external document, a full citation should be given. Enough information must be provided so that the reader can find the document with ease, whether it is an internal or external document.
9. Appendices – good SOPs will have figures, tables, and maybe even additional forms that must be utilized in conjunction with the SOP. Great SOPs have pictures, flow charts, diagrams, and more. These all belong in the appendices. NOTE: Some organizations have no issues with incorporating pictures directly into the Procedure section, whereas others do take issue. If possible, place pictures in the Procedure so as to eliminate misconceptions. Otherwise, place them in the Appendix.
10. Signature Approvals – every SOP needs to be written by an author, reviewed by a technical authority (i.e. a subject matter expert, or SME), and approved by an area owner as well as a member of the quality group (they usually own all SOPs). All of these key stakeholders must sign off on the document, giving it their seal of approval.
Each of these sections must be clearly written using direct, concise language. Any ambiguity will almost assuredly lead to variances in performance by the work force.
What now?
Once your SOPs are written and approved, now they need to be implemented in the day-to-day work. This is where training comes into play. A subject for another post, training is the other half of the critical administrative control coin. The best SOP is absolutely worthless unless it is effectively trained upon and implemented.
Comments