At the risk of sounding like a pharmaceutical quality assurance heretic, standard operating procedures (SOPs) often do not work as intended. In fact, they can do more harm than good by giving a false sense of security: "We must be okay; we have procedures for that."
Having procedures is certainly important. FDA cites the absence or inadequacy of procedures as a compliance problem. Industry spends a lot of money on staff and infrastructure to put procedures in place. And ironically, more money is spent on validating a document management system than ensuring the SOPs that flow through the system are effective.
Procedures are often more form than function. Words on a page do not necessarily make things happen as intended. I have observed the general neglect of procedures for many years and have concluded that there are common reasons why procedures don't work.
Let me turn the problems around and list these 12 ways to improve the effectiveness of procedures:
1. State the purpose of procedures.
Without a clear understanding of why we place such a high value on procedures in our industry, we can easily end up with a random collection of documents that vary in quality and content as much as the differences among authors who create them.
The purpose of procedures is to declare how the firm will operate in compliance with applicable laws and regulations, as well as how the business chooses to operate within its own norms. This purpose acknowledges that
ad libbing is not acceptable in the pharmaceutical manufacturing industry. Thus, the second purpose is to control the human variable and ensure operational consistency.
With these purposes in mind, the author of a procedure takes on a significant responsibility to apply the regulations to the business, as well as understand the operation where procedures are used.
2. Make process flow the backbone of procedures.
Since procedures declare "how" an activity is intentionally performed, then they should read in a logical, straightforward manner that is followable. Nothing is more frustrating than being accountable for performing an activity in a compliant manner with SOP that are disjointed and nearly impossible to tell who does what, when, where and how. If we want people to follow procedures, then we need to write procedures that people can follow.
A good practice is to start with a process flow diagram that depicts a technically correct (compliant), and operationally efficient sequence of activities. The traditional SIPOC flow diagram is in everyone's toolbox, and this is also an effective tool for writing procedures. Process flow diagrams help to develop a common understanding of the process, and it establishes the sequential steps needed to write an orderly procedure. If you can't make a process flow diagram, then you probably do not know the process well enough to write a procedure.
A procedure that is based on a good process flow diagram practically writes itself, because a procedure is the text that surrounds a process flow.
3. Seek input from the procedure users.
A process flow diagram is only as useful as the informed input that goes into writing it. Certainly this means including functional experts with technical and compliance knowledge. But active engagement by the users is essential. Review and approval of procedures by users' management is no substitute for thorough participation by actual procedure users.
Users know the obstacles and inefficiencies to the existing processes and are eager to remove the pain from their daily lives. The depth of knowledge, experience, and willingness of users to participate should not be underestimated. They will be the first to identify better ways of working that will promote compliance to procedures and efficiency.
It is a double bind to insist on strict compliance with procedures but not to create procedures that reflect the realities of the user. Ineffective procedures written in a vacuum invite work-arounds, which might--in the end--have been the more efficient process.
4. Promote clear writing of procedures.
Procedures should be straightforward and easy to follow. If you have ever assembled a do-it-yourself piece of furniture, you know how important clear instructions are. Too often procedures lack detail to perform an activity consistently, or the detail is scattered throughout the procedure.
There is a difference between clear writing and technical writing. Improving procedures is more often a communication problem, not a technical problem. We need to recognize that writing instructions for another person to follow is a high-level skill, and not everyone is qualified. We make the mistake of assuming that anyone is capable of authoring a set of instructions if they are the subject-matter expert.
Identify your clearest writers. Have them edit procedures for clarity, not just technical content. It should not be too much to ask for procedures to have clear and logical steps to follow.
5. Establish a style guide for authors of procedures.
Editorial style is a distinctive manner that makes a set of procedures belong together. Style is notably missing when procedures are significantly different and disorderly. One author may improperly write user process instruction in the responsibilities section; another author may carelessly refer to a form or other procedure that does not exist; another author might redundantly give the title "Procedure for..." when it is obvious that you are holding a procedure.
A style guide is useful for authors. A style guide not only standardizes the content of procedures, but it helps a procedure to make sense from a reader's perspective. Much like Instructions for Authors in a professional journal, a style guide helps procedures to be a document type that belongs together and has a common purpose.
Setting style expectations helps authors to write effectively and gives a body of procedures the level of professionalism that reflects the significance of the work being performed. It also shows respect for the user.
6. Ensure procedures are part of a document architecture.
Architecture is the overall organization and relationship of all pharmaceutical document types. But there is also architecture for procedures as a specific document type. The randomness of the table of contents for standard operating procedures often reveals lack of architecture. This is usually a symptom of an unstructured pharmaceutical quality management system.
The architecture of procedures typically reflects elements of a pharmaceutical quality management system such as Product Development, Manufacturing Controls, Engineering and Maintenance, Laboratory Operation--sub-groups of the pharmaceutical quality management system with related procedures that belong together.
Establishing an architecture for procedures elevates procedures to that of a pharmaceutical library that contains a wealth of operational knowledge and the best, compliant practices. Like any library, you know how its organized and where to go for the information you need.
7. Link processes between procedures.
Procedures connect to one another because inputs may come from one process, and the output may be received by another process. The linkage between these off-page connectors must be present and adequate for processes to be fluid across procedures. Short circuits are created when there is a reference to a process outside the scope of a procedure, but a procedure for that off-page process does not exist, or it is an informal practice.
When new procedures are created, or existing procedures changed or deleted, the effect on all other procedures within the pharmaceutical quality management system must be assessed. Maintaining working interrelationships between procedures is a challenge, but essential. Whether making seemingly innocuous editorial changes to undertaking a major quality system improvement initiative, the impact on other procedures must be addressed.
The pharmaceutical quality management system is like an ecosystem. Rarely can a change be made that does not have an impact somewhere else. Effective procedures not only make reference to other procedures where essential linkages exit, but the processes are also seamlessly stitched together.
8. Exercise control over procedures.
Procedural control takes many forms. The most obvious is a mechanism to ensure that only approved and effective procedures are accessible. Less obvious is understanding when historical revisions were in effect and what significant changes were made. Also, with various practices for procedure lifecycle milestones such as approval date, training date, mastered date, issue date, and effective date, the most important dates can be lost: When was the procedure approved by QA? When was the procedure made effective?
An unintended consequence of control is having a document management system that is bureaucratic and cumbersome. When the view is taken that manufacturing operations is central to the organizational purpose, then it is incumbent upon a service organization to provide an appropriate service level. Likewise, an understanding and elimination of the root cause for excessive changes is just as important to help to reduce the volatility of the pharmaceutical quality management system.
There is a balance between central control and responsiveness to the needs of the operation. The most effective companies find the sweet spot while providing the value add of maintaining the integrity of procedures, document architecture, and the pharmaceutical quality management system as a whole.
9. Identify procedure (system) owners and ownership behaviors.
Having an owner for set of procedures related to a given quality system is essential for accountability. That accountability includes being the most knowledgeable person internally about the system, the most informed person with respect to industry practice and regulatory enforcement trends, the point person for reporting the health of the system, and the one who ensures the system is continually effective for a dynamic business environment.
But ownership of procedures is often like a game of hot potato: you don't want to be caught holding it. But lack of ownership opens the door for anyone and any opinion to infiltrate procedures. The most problematic procedures are the result of lack of ownership and investment in the owners to become industry experts in the CGMP requirements and application of the requirements to the dynamic business. Identifying owners also establishes a network across business units for best practices and harmonization.
Selection of system (family of procedures) ownership should be thoughtfully made with the owner being the most responsible manager closest to the use of the system in daily operations. While there are high expectations for the owner, there should also be high rewards and priority given to invest in their training to keep current in CGMPs and industry practices.
10. Demonstrate respect for procedures.
Behaviors of immediate supervisors and top management define the boundaries of allowable practices. If procedures are just considered guidelines that are selectively followed, then there is no expectation for defined ways of working with predictable outcomes. When there is a disregard for procedures, there may be a company culture problem, or there may actually be problems with procedures. It's okay to say, "I can't follow this procedure, but I know how to make it better."
Procedures are made for man, not man for procedures. When procedures are well written and effective, there is comfort in knowing variation is controlled and the outcome is predictable. Supervisors must model respect for procedures not only by following them and expecting others to follow them, but to be actively engaged to ensure that procedures are as best they can be for their operation. No one should be the victim of poorly written procedures.
Nothing will sabotage regulatory compliance or quality system improvement more quickly and lastingly than lack of respect for procedures.
11. Train on procedures.
We say that we provide training on procedures. But do we really teach the purpose and importance of procedures, how they fit into the architecture, or how a given procedure contributes to the state of control and value to the patients we serve? Unfortunately, the common default is Read and Understand, check the box and then go on to the daily work.
The training effort is magnified for companies that undergo a lot of change either through voluntary quality system improvement, or involuntary regulatory enforcement action. There can be a false sense of security when the training statistics are published and high training percentages achieved. The reality is that such statistics are not a measure of learning. And when a nonconformance is detected, or a procedure is not followed, we compound the problem by requiring retraining as the corrective action.
Procedures are the primary content for training, and not all content is best learned by a Read and Understand approach. The training system should establish a gradient of training approaches that takes into account the subject matter along with a learning assessment.
12. Manage the change.
The field of Change Management has entered the CGMP compliance world. During my forty years helping companies to establish and improve pharmaceutical quality management systems, I have come to understand that CGMP compliance remediation and improvement is just as much about company transformation as it is system design and procedures.
Procedures are words on a page. They can be the best and clearest words on a page. They can even be the most respected words on a page. In the end, they are just words on a page, and words on a page do not necessarily make anything happen. Sometimes procedures and changes to procedures are difficult to embrace with the best of intentions. Some changes may be simply editorial, but there are some changes may go entirely against the way things were done before. Thus the behavioral sciences enter the technical world of pharmaceutics and CGMP.
Done thoughtfully with facilitation by change management professionals with experience in pharmaceutical manufacturing and CGMPs, change can be embraced and results sustained.
What are your experiences and recommendation?
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