Capture knowledge with procedure-based maintenance

Work instructions lay the groundwork for precision maintenance in pharmaceutical and other regulated industries.

By Marie Getsug, Commissioning Agents, and Patrick Wagner, Eli Lilly

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What does it mean to evolve from craft-based maintenance to procedure-based maintenance? The days of journeymen and maintenance technicians being capable of fixing or troubleshooting anything they confronted is no longer a realistic expectation. Following detailed directions adds an element of expertise to those willing enough to follow the disciplined, precision, process-driven instructions included in detailed work instructions. Couple the challenge of maintaining more sophisticated, complicated, automated, and robotic equipment with the demands of controlling the processes that support the manufacturing of pharmaceutical drugs, and it’s easy to see the criticality of an extreme level of control over the quality of the work accomplished. It’s necessary to expand the focus of maintenance beyond that of restoring equipment functionality; maintenance and reliability practitioners must understand the potential impact of their work, not just on the equipment and how it may affect the equipment reliability, but also on the product and process. This includes any potential impacts on the safety, integrity, strength, purity and quality (SISPQ) of the product.

Detailed work instructions ensure a common approach, implementation, and results, driving a standardized maintenance strategy across a facility. Certainly, ensuring that this document is utilized appropriately remains a responsibility, and quite often a challenge, for those managing maintenance technicians, as well as the technicians themselves. The other significant challenge that this approach presents is the inherent demand of authoring these detailed work instructions. Creating the detailed work instructions requires skills instrumental in documenting procedure-based maintenance, without demeaning the technician performing the work, while integrating the precision specifications, so often absent in work orders. As industry standards, especially in regulated industries, evolve from craft-based maintenance to procedure-based maintenance, technical writing skills will be critically utilized to produce high-level detailed work instructions.

Many maintenance programs are craft-based, meaning they are performed by technicians or journeymen with years of experience and a wealth of knowledge on the maintenance work to be performed and the capabilities and weaknesses of the equipment, and yet this experience is not documented anywhere. A well-designed and carefully presented maintenance work instruction and training program assists in the transition from a craft-based to procedure-based maintenance system. This strives to satisfy regulatory requirements, having documented procedures for maintenance work and the technician training, however, in no way diminishes the necessity for talented journeymen to execute the work instructions. The technicians may not be accustomed to following a procedure or documenting the results. It is necessary for the author of these instructions to be sensitive to the fact that the technicians may have never followed an SOP in the past, and, even more so, may question the basic necessity of following one presently. They may feel threatened that every step of the job is documented and perceive this procedure-based strategy as a negation of their expertise. With these considerations in mind, the style in which the work instructions are written can determine how the technician receives the procedure. The approach the maintenance department takes and its response to the technicians’ feedback is critical to establish buy-in and a continuous-improvement culture in a procedure-based maintenance department. Work instructions ensure that precision work is repeatable and documented and may help to cultivate a culture of inspiration within a regulated facility.

Regulatory expectation

The days of FDA investigations that only look at the surface of the maintenance department are no more; historically, FDA maintenance audits consisted of a check-over of the maintenance plan, PM program, and list of critical instruments. Now, the focus is a much more rigorous one: the FDA is actively looking at the maintenance and reliability programs of pharmaceutical and biotech manufactures with intricate detail. Well-documented asset logs of failures — with appropriate strategies implemented to prevent the failure in the future, a robust record of technician training — adding confidence that the implemented changes were executed appropriately, and lists of equipment specification, detailing the safety and efficacy of using such equipment, are areas of focus within this regulated industry that are fundamental to a successful maintenance program. This new level of regulatory control, documented through procedures, work plans, and training, ensures that the maintenance goal — controlled and precision work being performed — has been achieved. Furthermore, regulatory investigations may delve deeper, probing for unplanned maintenance events due to failure and appropriate follow-up. It comes to no surprise that a robust maintenance program, meeting system owner and regulatory expectations, is one that is well-documented, controlled, repeatable, and traceable.

Procedure-based maintenance

Writing detailed work instructions reduces human variation in maintenance activities and introduces new technicians to the standard requirements, and, most evidently, this process demonstrates the level of control necessary in this regulated industry. These instructions act as a living document, with a level of flexibility necessary for continuous improvement. Beyond ensuring consistency in maintenance activities, standardized work instructions promote acceptance by following a standardized format and ensuring that important considerations, such as safety or environmental hazards, are not overlooked.

Maintenance SOPs, or work instructions, are written to compliment the training of the technicians who are executing the contents of the work instructions, typically in the form of a work plan or work order. Typically, the work plan or work order is maintained as part of the computerized maintenance management system (CMMS). These work instructions provide a connection between the assets, the work plans, the CMMS, and the training records of each technician to work on these assets. The work plans provide the strategy for how each asset will be maintained, the tactical details required to ensure the control required in a regulated environment, and the reliability desired in the operations, maintenance and reliability departments. The work instructions give specific information regarding the maintenance to be performed. The integrated system helps to plan required maintenance and demonstrates the control and training required to meet the requirements of the regulatory agencies.

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