The quality management system (QMS) is the foundation of success for any organization that manufactures regulated products. The quality system reaches departments across the entire product lifecycle, from design and development to validation testing to clinical trials and market segmentation, ensuring that the product is compliant with all applicable regulations and standards while meeting market need and customer specifications. The quality system also produces definitive data that management can use to make strategic business decisions on market segmentation and resource allocation. A well-designed quality system can make an organization stronger, more unified and better situated to compete successfully in the marketplace.
To achieve success, a solid framework of processes, policies and procedures is built on top of that foundation, defining how the organization is going to meet its business objectives. Quality Standard Operating Procedures (SOP’s) are the glue holding that framework together, defining responsibilities, methods, tools and metrics for each step in the product development lifecycle. Detailed and specific quality procedures help an organization remain compliant while avoiding the unnecessary expense of product redesign and reformulation. Clear quality procedures also ensure that every person involved in the product is appropriately trained and knowledgeable about roles, responsibilities and regulations.
Crafting an organization’s quality SOP’s can be a massive undertaking, but sometimes just knowing where to start can be the biggest hurdle. As is the case with many daunting projects, the best place to start is right at the very beginning.
Where Do I Start?
Always start with the regulations.
Your quality management system and procedures must be equal to the level of risk and overall complexity of the product, the extent of the regulatory requirements, and the size and complexity of the organization. It stands to reason that the identification of all applicable regulatory standards and requirements for the product would be a good jumping off point to start the procedural journey.
From good manufacturing practices (GMP) to process standardization (ISO) to FDA quality system regulations (QSR) and beyond, understanding the documentation and process requirements of each regulating agency will help outline the basics of your quality management system SOP’s. While there are some regulations tailored for specific industries, there are some general regulations that should always be considered when developing your quality system procedures:
Medical device manufacturers are held to a higher regulatory standard because of the potential risks their products can pose to patient health and safety, so those companies must also consider these regulations:
- ISO 14971: 2019 – risk management
- ISO 13485: 2016 – quality management
- 21 CFR 820 – GMP for medical devices
Pharmaceutical manufacturers must also consider the processing, packaging and storing requirements listed in 21 CFR 210/211.
The sheer number of regulations can be just as overwhelming as starting to write the procedures. The various standards have been harmonized somewhat over the years to minimize overlap and make review easier, but it is still worth the time to review each set of regulations to be sure your SOP’s will cover all the requirements.
Determine Document Structure
Quality procedures can be written in a variety of formats – as a series of paragraphs, as a flowchart, or as the more traditional narrative with sections, sub-headers, and bulleted steps. The best format for your QMS SOP’s will depend on the number and complexity of the processes to be defined and whether there is a standard template for organizational procedures. At a minimum, a compliant QMS procedure should contain the following elements:
- Purpose – identifies the reason for the SOP
- Scope – details which aspects will and will not be covered by the SOP
- Definitions/Glossary of Terms
- Roles, responsibilities and authorities of all people/functions included in any part the SOP
- Definition and listing of data and records that could result from the activities described in the procedure
- Identification of changes, date of review, approval and version of the document should be included in accordance with the organization’s document control policies
- Main descriptive section – describes the what, where, when, how, who and why of the SOP. This section should also list the inputs and the resources needed, and the expected outputs
- Appendices, as needed
The format selection should also take into consideration the cross-functional intention of the quality procedures. These will be read and followed by employees with a variety of skillsets and responsibilities, and not all sections of the chosen format may apply to all departments. For consistency, the format should be standardized across the organization and a simple “Not Applicable” added when needed.
Even with the format, scope and applicable regulatory requirements defined, an effective quality SOP cannot be written until all the pertinent information is in hand. Because quality procedures are cross-functional by design, inviting other departments to the quality table can facilitate this information gathering and improve the accuracy of the procedures.
There will be any number of questions to ask to fully understand the process being documented – are there any steps that do not need to be detailed in this procedure? Are there steps that require a separate SOP of their own? What is the potential for non-compliance if a step is not documented? Without a complete understanding of the process, creating an effective procedure will be much more difficult, and this is where strong relationships and good communication with the various departments can streamline the collection of information.
Interdepartmental collaboration is also key in determining how the new quality SOP aligns with others across the organization. The quality procedures should not supplant procedures from individual departments, as the whole organization becomes more efficient when the alignment between the QMS and departmental procedures is strong, and cross-functional interaction is seamless.
Ready, Set, Write!
Information collected, format selected, regulations clarified – now the actual writing of the SOP can begin. However, with so much information at hand, the temptation to include absolutely everything in the name of transparency can be tough to ignore. Quality procedures should be written as simply as possible, with enough detail that a competent person can perform the task described while remaining fully compliant. If they are too long or unnecessarily wordy, they will not be read as needed and will be harder to maintain.
Once completed, the SOP will make its way through the approval process. All employees (and perhaps some contractors) will have to have documented training on the new procedure, which then becomes part of the organization’s quality manual and is reviewed and/or updated annually until it reaches obsolescence.
Crafting effective and meaningful quality procedures can be less taxing than anticipated. With a little preparation, some research and a lot of collaboration, you can create quality SOP’s that will keep the organization compliant, make it more efficient and potentially save money at the same time.