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The QA Pharm Published: 04/06/2015
At the risk of sounding like a pharmaceutical quality assurance heretic, standard operating procedures (SOPs) often don’t work as intended. In fact, they can do more harm than good by giving a false sense of security: “We must be OK; we have procedures for that.”
Having procedures is certainly important. The U.S. Food and Drug Administration (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 that the SOPs that flow through the system are effective.
Procedures are often more form than function. Words on a page don’t 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.
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 skills and viewpoints of the 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 adlibbing isn’t 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.
Since procedures declare “how” an activity is intentionally performed, they should read in a logical, straightforward manner that is easy to follow. Nothing is more frustrating than being accountable for performing an activity in a compliant manner using an SOP that’s 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 compliant and operationally efficient sequence of activities. The traditional “supply, input, process, output, customer” (SIPOC) flow diagram is in everyone’s toolbox, and it’s also an effective tool for writing procedures. Process flow diagrams help to develop a common understanding of the process, and they establish the sequential steps needed to write an orderly procedure. If you can’t make a process flow diagram, then you probably don’t 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.
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 participation 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 shouldn’t be underestimated. They will be the first to identify better ways of working that will promote compliance to procedures and efficiency.
It’s pointless to insist on strict compliance with procedures but not 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.
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 shouldn’t be too much to ask that procedures have clear and logical steps to follow.
Editorial style is a distinct tone and presentation 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 instructions in the responsibilities section; another author may carelessly refer to a form or other procedure that doesn’t exist; another author might redundantly give the title “Procedure for...” when it’s obvious that you are holding a procedure.
A style guide is useful for authors. It not only standardizes the content of procedures but also helps a procedure make sense from a reader's perspective. Much like instructions for authors in a professional journal, a style guide helps procedures to function as a series of documents that belong together with a recognizable 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 users.
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, and laboratory operation These are subgroups of the pharmaceutical quality management system with related procedures that belong together.
Establishing an architecture for procedures elevates them to a pharmaceutical library that contains a wealth of operational knowledge and the best, compliant practices. Like any library, you know how it’s organized and where to go for the information you need.
Procedures connect to one another because inputs may come from one process, and the output may be received by another process. The link 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 doesn’t exist, or it is an informal practice.
When new procedures are created, or existing procedures are 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 doesn’t have an impact somewhere else. Effective procedures not only reference other procedures where essential links exist, but the processes are also stitched together seamlessly.
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 life cycle 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 are central to the organizational purpose, then it’s incumbent on a service organization to provide an appropriate service level. Likewise, understanding and eliminating the root cause of excessive changes is just as important to help reduce the volatility of the pharmaceutical QMS.
There is a balance between central control and responsiveness to the operations’ needs. The most effective companies find the sweet spot while providing the value-add of maintaining the integrity of procedures, document architecture, and the pharmaceutical QMS as a whole.
Having an owner for a 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. Identifying owners also establishes a network across business units for best practices and harmonization. The most problematic procedures are those with no ownership or with owners who aren’t industry experts in current good manufacturing practices (CGMPs) and are unwilling to apply them to the dynamic business.
Deciding on the ownership of a system (i.e., a family of procedures) should be thoughtfully done. The system’s owner should be the most responsible manager closest to where the system is used in daily operations. And although there are high expectations for the owner, there should also be high rewards and priority given to investing in this person’s training to keep abreast of CGMPs and industry requirements.
Behaviors of immediate supervisors and top managers define the boundaries of allowable practices. If procedures are just considered guidelines that are selectively followed, then there’s no expectation for defined ways of working with predictable outcomes. When procedures are disregarded, there may be a company culture problem, or there may actually be problems with procedures. It’s OK 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 that 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 also by being actively engaged in ensuring that procedures are the 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.
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 get back to work.”
The training effort is greater 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 aren’t a measure of learning. And when a nonconformance is detected, or a procedure isn’t 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.
The field of change management has entered the CGMP compliance world. During my 40 years helping companies establish and improve pharmaceutical QMS, I’ve 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 don’t 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 other changes may go entirely against the way things were done before. Thus the behavioral sciences enter the technical world of pharmaceutics and CGMP.
When done thoughtfully, with facilitation by change management professionals with experience in pharmaceutical manufacturing and CGMPs, change can be embraced and results sustained.
First published March 28, 2015, on The QA Pharm.
The QA Pharm is a service of John Snyder & Co. Inc., provider of consulting services to FDA-regulated companies to build quality management systems and develop corrective actions that address regulatory compliance observations and communication strategies to protect against enforcement action. John E. Snyder worked at the lab bench, on the management board, and as an observer of the pharmaceutical industry for more than 30 years. His posts on The QA Pharm blog are straight talk about the challenges faced by company management and internal quality professionals. Synder is the author of Murder for Diversion (Jacob Blake Pharma Mystery Series Book 1).
© 2023 Quality Digest. Copyright on content held by Quality Digest or by individual authors. Contact Quality Digest for reprint information.
“Quality Digest" is a trademark owned by Quality Circle Institute, Inc.
Links:
[1] http://theqapharm.blogspot.com/2015/03/12-ways-to-improve-procedures.html