Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to write standard operating procedure that holds up to audits.
Q. I work for a contract manufacturer and am in charge of the standard operating procedures (SOPs). During customer and regulatory audits, we keep being cited for inadequate SOPs. Can you give me some advice on what constitutes a well-written SOP?
A. You are not alone. In 2014, “inadequate standard operating procedures” was one of the top five most-frequently-cited FDA 483 observations. SOPs are one of the first items auditors review during inspections. SOPs need to reflect your operations and should not be written for regulators. SOPs should be written for your personnel to conduct operations with consistency and quality thus assuring regulatory compliance. Do not write SOPs because you think the regulations require them or for a process, procedure, or operation listed in the regulations that you do not perform. This will continue to lead to audit observations.
So what are the characteristics of a good SOP? Effective SOPs are tailored to an organization’s design and needs and contain sufficient detail to allow personnel to conduct operations as management wants. If you have an experienced work force, you may need less detail. SOPs take into account who has the authority to make decisions and clearly define accountability (i.e., who per forms what actions). SOPs also provide guidance on what to do when things don’t go right; they delineate decision points and actions to take for each decision. SOPs define the outputs from each process (documentation, product), who owns the process, and identify other stakeholders for the process, which helps determine who requires training on the SOP. The SOPs also specify who needs to ensure the process is working and who initiates changes when needed.
So what do you need to consider to write a clear, concise SOP with the right amount of information accurately reflecting your established processes? Keep your mind open to different various communication types. SOPs may use various presentation styles as a means of communicating the details of the SOP.
The following are examples of presentation styles that you may want to consider using when writing your SOPs:
- Playscript (operator does “a” now and “b” next)
- General description-paragraph form
- Flow chart
- Any combination of the above as long as personnel can follow the instructions.
Determine the type of style and level of detail that is most effective for your personnel. Also, consider the predominant primary language (it may not be English) and general understanding level of your organization when writing SOPs. Depending on the make-up of the workforce, you may need to consider having dual-language SOPs, which might require translation expertise.
Certain recommended elements should be included in SOPs. Remember, the format and content of SOPs are not defined by the regulations. Each company must establish the SOP format and content that accurately reflects their operations. The seven basic elements for any SOP are:
- A unique title that corresponds to a unique document number: This combination should be specific enough so that the document referred to can’t be confused with other documents in your document collection. The unique reference number is often an alpha/numeric combination that specifies the functional department that employs the SOP. This unique identifier often includes the version of the SOP for easy reference and to ensure the current version is being used.
- The date that the SOP is considered operational and should be followed by employees: Dictating one date format versus another creates unnecessary/irrelevant deviations. The focus of dates should be their legibility.
- A purpose and a scope that describes why the company has this SOP (what process or procedure is being described) and who in the company needs to adhere to the contents of the SOP: The purpose and scope of an SOP are interrelated. The purpose describes why the SOP is needed, and the scope defines the boundaries of the SOP.
- Roles and responsibilities: The roles and responsibilities should not be a reiteration of the procedure but should describe the parties responsible for ensuring proper execution of the SOP (who may or may not be the individuals performing the step-by-step procedure).
- Change control history of the document: The change control history is important because it establishes the history of the document from initiation to obsoletion. In some cases, it is important for the company to know what sections of an SOP were changed and why they were changed. This valuable information is captured through the change control history and should be included in the change control request.
- Who can sign and vouch for the contents of the document: The SOP is not complete until the official required signatures are applied to the document. The official signatures required for any document may vary from department to department and indicate that the changes to the SOP are: consistent with company policy, ensure the operation continues to be executed in a predictable manner, do not affect the validation status or quality of the product, and that the step-by-step instructions represent the repetitive actions to be performed to ensure the predicated and expected outcome defined by the SOP.
- The step-by-step instructions: The step-by-step instructions represent the repetitive actions to be performed to ensure the predicated and expected outcome defined by the SOP. There is no rule that SOPs need to be written words. If the operation in the SOP can be described easily with a flow diagram, there is no reason not to use this type of informational display. The instructions should not be too long. The longer the SOP is, the poorer the retention of the information. The general rule is SOPs should not exceed 10 pages. If your SOP exceeds 10 pages, you might want to consider breaking it into smaller operations, if possible.
If you keep these points in mind when writing your SOPs, you should stop receiving the ‘inadequate SOPs’ citation.
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