Explore the key considerations for Standard Operating Procedures (SOPs) for Medical Device Companies
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If you are a medical device company, the FDA requires you to not only “establish” procedures but also “maintain” them. That criteria can be difficult to follow when you are inexperienced with FDA terminology.
By creating effective Standard Operating Procedures (SOPs), you will amplify the effectiveness of your procedures and achieve compliance. But how do you write an SOP? We have written an easy-to-follow guide for writing clear and concise SOPs making FDA submissions 10x easier!
Current Penalties with Poor SOPs
Like any procedure, actions can only be carried out when there are legible and comprehensive instructions to follow. Many medical device companies do not have the necessary expertise to write SOPs which is reflected in poorly written document procedures. Failure to develop a clear manual of how a procedure should be carried out may result in a 483 or even a warning letter following multiple citations by the FDA.
483 Letter
- After an inspection is conducted, an FDA official may write down an observation made of your facility. The official may list the alleged deficiencies or issues of non-compliance in the company’s quality system.
Warning Letter
- Warning letters are issued for violations of “regulatory significance”. Significant violations are those violations that may lead to enforcement action if not promptly and adequately corrected.
As you can tell, SOPs are a key component of your quality system and usually lead to many 483s and warning letters for medical device companies, but why?
Looking for a Quality Management System to reduce paper documentation, check out Sierra QMS
Importance of Clear Instructions in SOPs
Since every medical device is different in development and design, each written procedure should parallel the device’s unique considerations. Your SOPs should outline specific instructions that aren’t only coherent to your team, but also to any third parties like FDA inspectors or end-users. When writing your own Standard Operating Procedures be sure to keep these statements in mind:
- Is this statement clear enough to comprehend for everyone?
- Make your statements brief and concise.
- Replace overly technical language with simpler wordage.
- Is the structure of the information legible?
- Instead of writing statements in bulk paragraphs, using bullet points or lists will maximize clear communication.
- Is the language ambiguous in any way?
- Do not use a passive voice but instead commands, such as:
- “Evaluate”, “Adjust”, “Identify”
- Use words that clearly define time, such as:
- “Annually”, "Monthly", “Bi-weekly”
- Do not use a passive voice but instead commands, such as:
Follow a Clear Format for Your SOPs
Now that you know what to keep in mind when writing your SOPs it’s time to pay attention to the format:
| Sections |
Descriptions |
| 1) Title | Includes the title, document number and version to identify this particular SOP. |
| 2) Revision History | Includes details when document was created and if any changes were made (when and why). |
| 3) Table of Contents | Outlines entire document sections by subheadings that encompass entire document. |
| 4) Introduction (Purpose) | Conveys in 2-3 sentences the intent of the whole document. |
| 5) Scope | Explains to who or whom the purpose of the SOP is directed towards. (Shouldn't be open to interpretation) |
| 6) Roles and Responsibilities | Highlights which roles are responsible for executing the activities in the procedure. |
| 7) General Requirements | Explains each procedure thoroughly by organizing them into major steps. |
| 8) Approvals | Details approval and administrative distribution requirements of each procedure. |
| 9) Change Control | Input systematic and sequential entry of data supporting change in a project. |
| 10) Related Documents | Attach any related documents or references by linking them. |
A Toolset to Manage your SOP Documents
Writing effective SOPs can be a daunting task for medical device companies that are unexperienced with FDA regulations. Yet, SOPs are important because they keep your medical device development on a safe and efficient track while demonstrating to FDA that you take your quality processes very seriously. Without effective SOPs, your organization is vulnerable to 483s and warning letters making your product’s journey to market even more challenging
Here at Sierra Labs, we often help companies in the regulated space write SOPs that are up to FDA and other regulatory bodies’ standards (not the generic and unspecific ones that can be downloaded from the internet that often fall short of compliance).
Beyond helping your organization construct effective SOPs, Sierra Labs has worked with healthcare and life science companies to build incomparable traceability and visibility throughout their operations by developing a quality program. We can help you design your SOPs and shape your quality program by providing support to your quality teams and functions.
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