SOP's
Standard Operating Procedures (SOPs) are the documented processes that a Company has in place to ensure that services and products are delivered consistently every time. SOPs are often used to demonstrate compliance with the regulation or operational practices and to document how tasks must be completed at your Organization.
Often when a company is growing and just starting, the CEO or Management team tend to make all the internal decisions. As the company reaches a specific size, this form of decision-making can limit its capacity to grow further as the CEO or Management team can’t make all decisions in the appropriate Time-frame or be involved in every aspect of the Business. In this instance, your SOPs would typically take over and act as your governing word. SOPs can also be an effective way to communicate changes in the way your business operates to your Employees.
The requirements for SOPs and their format will range from Industry to Industry. SOP requirements could also depend on the type of activity your organization is undertaking, or what regulations your business is governed by. In clinical research, these requirements are precise.
SIX BENEFITSSIX BENEFITS OF WRITTEN STANDARD OPERATING PROCEDURES
From training and hiring to work policies and procedures, Standard Operating Procedures — or SOPs — help companies stay organized, operate smoothly, and ensure that employees understand how to accomplish their assigned tasks. But here’s one thing we’ve learned from more than a decade of working with companies of all sizes: Even though nearly all companies have some sort of SOPs in place, they don’t always have them written down. Or if they do have them written down, it’s been years since they’ve reviewed or updated them.
In most cases, it comes down to time. When day-to-day operations get hectic, internal projects are often the first to fall to the wayside. And while it’s true that writing, reviewing, and updating your company’s SOPs can be time-consuming, we think it’s worth it in the long run. Need a few reasons to make written SOPs a priority? Here are just a few benefits of having written SOPs:
Writing proceduresWriting procedures from the end user's perspective
Always remember that SOPs should be written from a purely practical perspective from the point-of-view of those who will actually use them. Here are some simple yet important guidelines to keep in mind to write an end user-focused SOP.
Keep sentences as brief as possible and use simple, common terms. Never obfuscate the meaning of instruction by using overly technical or jargon-filled terminology when a simpler, clearer word or phrase communicates the same idea.
Be mindful of what you write as well as how you write it. Simple action-oriented verbs such as “identify,” “direct,” “evaluate,” and “review” get the point across without requiring interpretation. If at all possible, do not use the passive voice when structuring sentences as this has been shown to confuse and misdirect attention away from important ideas.
Always avoid using generalized terms that give no tangible meaning. Words like “periodic” “typical” “general” and “should” do not enforce any consistent direction or execution of a directive — the main goal of having an SOP in the first place.
The main terms here are “may,” “must,” and “should.” Remember that using the word “may” gives personnel decision-making power and/or flexibility depending on the context. “Must,” is always mandatory, and “should” is by nature conditional.
If your SOPs consist of long, dense paragraphs, chances are there’s a better formatting scheme to follow. Bulleted items and lists are particularly effective for certain pieces of information as they focus attention and slow the reader’s pace.
A Model FormatA Model Format for an Effective SOP
The model described below lays out the components of an SOP in a way companies can adapt to their own needs and situations.
Header: This should include the title, document number, and version. The header should clearly identify the activity in question and contain any relevant keywords.
1] Purpose :
The purpose should define the intent of the document and be no longer than one or two sentences. It needs to be detailed enough so end users can quickly recognize what the document covers with no other detail included.
2] Scope :
This defines to whom or what the particular set of procedures applies. Many SOPs cover only what is in scope without stating what is not in scope, however it may be appropriate to state both. Judge the completeness of your scope by asking yourself if what is written leaves anything for interpretation. If the answer is yes, there’s likely more work to do. By clearly spelling out what and who is and is not in scope, you offer everyone to have the same starting point of understanding.
3] References and Related Documents :
Offer documents and references needed to understand and effectively execute the procedures in addition to other SOPs, or government-issued documents the SOP references. If you use a Master Reference Document, list the title and any identifying numbers for the referenced documents. If not, provide the entire reference cited and use the Standard reference format for publishing.
4] Definitions:
Clarify any terms that may not be familiar to end-users and spell out any acronyms or abbreviations that are used. Remember that while a term may be familiar to you, it may not be familiar to them. What’s more, a clearly defined SOP can help regulators understand your procedure without requiring further investigation during an inspection.
5] Roles and Responsibilities :
Define the roles responsible for executing activities within the procedure. If there are a large number of roles listed, consider narrowing the scope and create multiple SOPs to complete the task.
6] Procedure :
Remember that regulators work to hold companies to standards set forth in their written procedures if those standards and practices are necessary and capable of being maintained. The FDA wants to ensure that standards meet compliance expectations without containing so much material that it may actually create compliance risk. To avoid this, break the procedure down into the following components.
Major steps: Your SOP should include only the steps necessary for accomplishing the objective of the procedure.
Individual action steps within each major step.
Notes: These should be provided separately and be given to offering information for clarifying the process and/or responsibilities and possible warnings.
7] Appendices :
These typically work best as a flow chart to aid in explaining the procedures during an auditor for those who learn better visually.
8] Revision History:
Record the changes made to a procedure and justification or the reason why the procedure was created.
Approval Signatures: This is usually found on the cover or the back page. Some SOPs require various approval signatures. Key roles in play include the Author, Reviewer, Management Approver, and Quality Reviewer/Approver. It’s important to note that Under 21 CFR Part 211, the quality control unit is required to approve all procedures that may impact “the Identity, Strength, Quality, and purity of the Drug product.”