Most sponsors, CROs and technology vendors in the life sciences industry have a good understanding of the risks associated with inferior process documentation. Minimally, failing an audit means lost time and money, a damaged relationship or reputation with the agency or a customer (or both) and diverted resources as the organization attempts to take corrective action or respond to an audit report. These outcomes are not worth the risk to most organizations.

In our industry, you don’t get points for good intentions. If it isn’t documented, it didn’t happen. Therefore, a great deal of time and energy is spent on process documentation.

The “burden” of writing, reviewing, approving and maintaining process documentation can in fact be considered an investment in organizational assets. It is not the most glamorous of activities, but good documentation can save your business. As exciting as this sounds, many of us have still nodded off a time or two when reviewing standard operating procedures and the vast majority would still choose a trip to the dentist over SOP writing.

Yet, well-documented procedures don’t have to be painful. In fact, a solid collection of SOPs and supporting documents can act as a critical foundation for process improvement and organizational efficiency. (If you don’t know what you are doing, you can’t improve upon it.) Simple, well-written process documentation is attainable. By following a few logical steps, smart organizations can realize a rapid return on their process investments.

Understand the Document Lifecycle

It is important to understand the lifecycle of process documentation because it requires a long-term commitment by the organization. The lifecycle begins when the need for a new process is identified. The lifecycle continues through process development, documentation, review and approval. Employee training on the approved process document is

conducted and then periodic reviews are scheduled to incorporate updates while the documents are actively being used. At some point in the lifecycle, the documents will be deemed obsolete and should therefore be archived. This on-going process requires continued input from process owners, par-ticipants and management.

There are costs associated with the lifecycle, but greater expense is incurred when you don’t have documented processes. Without documented processes, process participants will see redundant processes that are flawed by rework scenarios, and poorly designed processes that don’t incorporate appropriate quality checks. Both of these scenarios result in less than satisfactory deliverables at the end of the process and measurable costs associated with rework and redundancy.

Determine the Type of Process Documentation Required

Process documentation may be written in various formats. SOPs document a process in the form of “who”, “what”, “when” and “how”. They clearly identify responsibilities and action steps associated with a process or a portion of a process. These documents are usually created for key business processes and are presented in a standard format that outlines responsibilities and procedural steps to complete a specified process.

Different types of process documentation may complement or support SOPs. For example, guidance documents and policies are often used to add texture and detail to SOPs. Guidance documents may take the form of checklists, templates or desk instructions that assist personnel in performing tasks as specified in SOPs. Guidance documents usually describe the “how” and “what” of a process to ensure consistency of method. Policies document an aspect of the process and what is expected in the form of management dictates.

Initiate the Document Development Process

Once a new or revised process is identified, a team should be assigned to create the process and document it. The team members should include representatives with technical and business knowledge of the process as well as representation from the quality assurance (QA) function. The QA resource can guide team members through the documentation process and also finalize and track all final process documentation.

The team should define the purpose and scope of the process and begin to gather information about the process. Tools such as questionnaires and surveys may be used to research current or best practices. Interviews may also be used to gain additional insight into details or challenges of the process. If it is a completely new process for an organization, it may also be helpful to look outside of the company for suggested best practices or to gauge the intricacy of the process. This type of external data will help the organization to institutionalize best practices and learn from other company’s experiences. Once information is gathered, it is important to confirm what type of process documentation will be required. Depending on the complexity and criticality of the process, a policy, guidance document or SOP may be drafted.  

Many SOP documents include graphical depictions of process flows that illustrate the tasks and responsibilities. Procedural steps should be reviewed to determine where quality could be built in by determining what could go wrong, formulating preventative and/or backup actions and assuring that the appropriate checks and balances are added into the process steps. Analysis and documentation of these scenarios provide the most complete guidance to users and minimize the need for individual interpretation of the documentation. Cross-functional participation in documentation development ensures that final documents are not redundant and that appropriate connections are made across integrated processes.

Once the process documentation is drafted, the document should go through a cross-functional review and approval process. Any related or supporting documents should also be included in the review at this time. As the document is finalized, an effective date should be applied and the document should be entered into a formal, controlled document process. There are systems that will manage this process automatically offering version and access control, alerts and automated review workflows. Whether technology is used or a manual process is instituted, storing the document in a controlled environment and tracking official updates are critical activities. This usually involves assigning a code or unique identification to each process document, assigning an effective date and a review date and documenting an archival date if applicable.

Train Your Resources

Once you have expended the energy to create good documentation, make sure to finish the job by conducting routine training on any new process documentation. Many companies start out with the idea that a process is complete once a new technology is implemented. Developing and documenting good training on new processes, technologies and deliverables is considered a luxury. This is another area where you will find that if you don’t document it, it didn’t happen. Training records tell a story of your company’s commitment to quality processes. If training records are not kept up-to-date, you will most likely spend a lot of time determining whether a process issue is a result of a bad process, lack of training, poor training or untimely training.

Documented training is particularly useful when process improvement initiatives are considered. When an organization reviews process metrics for a specified task, it may become clear that a particular task or activity requires significant numbers of resources and time. A glimpse of training records may provide quick insight into whether the right resources have been adequately trained. It may also show that the right resources were trained but perhaps the timing of the delivery of training was inappropriate. In either case, significant cost savings can result from minor adjustments (changing the timing of training relevant to a particular process or including additional attendees to the training program).

More Points To Consider

As with any collection of documents that are compiled from multiple sources, the use of templates will help maintain consistency among authors and functional areas. Templated process documents can guide the novice through the document creation process while also providing consistency. Templated documents can be designed to offer content guidance as well as formatting standards. As your collection of process documents begins to expand, consistency across documents will ease the burden of updates. Many process documents will be related to each other or will be referenced within a different document. Consistency of format speeds the quality assurance process by enabling quick search and retrieval during cross document quality checks.   

Good process documentation requires organizational commitment. Simple document standards facilitate development and use of the documentation. Good process documentation also requires focus and coordination. It helps provide insight into how and what your organization is doing and offers a strong foundation for process improvement. Without good documentation, your processes don’t exist.

Monique Garrett is vice president, marketing for Wayne, PA-based Octagon Research Solutions. She can be reached at [email protected].