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

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.

The CMMS is often used to link every work plan to an asset or equipment record and each work plan and work order must have supporting work instructions. In addition to this, documented training records are required that demonstrate each technician who performs work on an asset has been trained to do so. This often includes a practical demonstration of performing the work prior to being qualified or certified on the given tasks.

A well-integrated, procedure-based maintenance and reliability system is one that is driven by precision work and documented in work instructions. The work plans, developed as a result of process investigations — as manifested in reliability-centered maintenance (RCM) plans or failure modes and effects analysis (FMEA) — drive the content of these instructions and are reflective of an understanding of the unique asset or system and its given operating conditions. As industry standards evolve from craft-based maintenance programs towards a procedure-based strategy, and as equipment and systems become increasingly sophisticated and complex, this well-integrated system will provide the fundamental groundwork to ensure that quality work is performed, is accurately documented, and is compliant with regulatory requirements within such a tightly controlled industry.

Technical writing

Greater business demand for improved performance and equipment reliability consequently drives the necessity for detailed technical documents that provide maintenance instructions. Technical authorship of these work instructions may initially appear to be a daunting undertaking, but the resources necessary to create high-level work instructions are readily available within a pharmaceutical manufacturing facility, provided that the author knows where to look.

Before any ink meets paper, it’s important, first, to define the expectations of the work instruction. The level of detail and organization is flexible, dependent on how the work instructions will be utilized and also on the expertise of the intended audience. Understanding the appropriate structure and amount of explanation best suited for a facility’s unique needs will determine the level of detail required of the text. Work instructions may be organized in two different approaches: all work instructions pertaining to an asset may be included in one large index or each procedure may exist in a standalone document. The first approach, where all instructions pertaining to an asset are kept in one location, may result in a rather cumbersome document; however, with this organization comes increased regulatory confidence in the maintenance strategy and in those executing the work. The second strategy is not as popular within a regulated industry, as thousands of standalone documents may result from the separation of individual work instructions, meaning a significant amount of documentation to control.

There are at least two different approaches to writing work instructions. The free format, presented in paragraph form, is read like a book. This format is most familiar and is therefore easy to follow. Each maintenance step is numbered, with the level of detail suitable for the subject matter included in each step. The table format separates text in columns, where each subsequent column may add another level of detail to the general procedure. The first column may list the task to be performed — for example, remove the belt guard or torque to X ft/lb — with a picture or sketch in the third column.

Photographs are a useful tool in either approach and may be integrated throughout the procedure to help eliminate any confusion that may result from the written procedure. Pictures should be taken of the actual equipment to be maintained, with additional pictures or sketches depicting the exact location on the equipment to orient the technician properly when performing the work.

Adequate preparation is fundamental in quality production. Research will be required in order to document the maintenance activity adequately and in sufficient detail. The information included in the procedure is equipment-specific and gleaned from many sources. The bulk of information will come from manufacturer-provided turnover packages and from operations and service manuals.

The following sections should be represented in the work instruction:

1. Purpose/Scope
     1.1. The purpose should describe why the document was written. Since the work instruction will be written for a specific piece of equipment and maintenance activity, these details should be included in the purpose of the maintenance activity.
     1.2. The scope should describe what the document covers: equipment name and model number, description and use of the equipment and how the work instructions apply to that equipment.

2. Preparation Work
     2.1. This includes scheduling with the equipment owner and notification of affected departments and groups such as the control room and operations prior to and following accessing the equipment and utilities to perform work depicted in the work instructions.
     2.2. Document the process and procedure to achieve the required preparations for access to be granted and work accomplished.
     2.3. Document in the preparation section all requirements for turnover of the equipment to maintenance and return from maintenance to operations.

3. Safety
     3.1. This section could be called health, safety, and environment or some other similar heading. The work instructions must contain any known or anticipated safety hazards and the methods required to mitigate the hazard. Check the operations and maintenance manuals for any hazards specific to the equipment or the function to be performed.
          3.1.1. List any permits required.
          3.1.2. List any required PPE.
          3.1.3. Ensure all necessary LOTOs have been implemented.
          3.1.4. Specify any potential environmental hazards and how to mitigate the hazard (wipe up spills, dispose of hazardous material properly (list where/how, if known)), and do not allow toxin to enter the drain system. Specific toxin must be listed and supporting MSDSs referenced.
          3.1.5. Reference the job hazard analyses (JHAs) for the equipment. If no JHAs are available, utilize the JHA thought process to ensure all hazards are contemplated and reflected in the final document.
          3.1.6. Regarding automation, highlight any special provisions for work being done to equipment with interlocks, protective devices, and other special safety considerations.

Marie Getsug is senior consultant, Maintenance & Reliability Services with Commissioning Agents. She is an experienced maintenance and reliability (M&R) subject matter expert with 28 years of experience in multiple industries including serving as the maintenance or reliability manager for four Fortune 100 companies. She was instrumental in launching and is currently the past chairperson of the Society for Maintenance and Reliability Professionals’ Pharma and Biotech Shared Interest Group (SIG). Getsug is a manufacturing and supply chain professional with experience leading high-performance work teams and systems to excellence, demonstrating world-class results by building a culture of inspiration, motivation and collaboration. Getsug leads change initiatives such as changing maintenance from reactive to proactive and building new processes or facilities. She has experience in changing the culture of facilities with lean strategies like new work systems, reliability-centered maintenance (RCM), total productive manufacturing, and theory of constraints, while building a self-managed and inspired work culture and designing means to sustain manufacturing plants through innovation. Getsug specializes in creating and executing M&R assessments to identify gaps necessary to create a strategic plan, roadmap, business case, and ROI. Getsug holds a B.S. in chemical engineering from University of Wisconsin, Madison, and holds the following professional certifications: CMRP — certified maintenance and reliability professional from SMRP, CMRT — certified maintenance and reliability technician from SMRP, certified PMP — project management professional from PMI, CPIP — certified pharmaceutical industry professional from ISPE, reliability centered maintenance II facilitator from Aladon Network, certified Level I thermographer from Infraspection Institute, certified vibration analyst from Mobius Institute, and certified Level I machine lubrication technical from ICML. Contact her at marie.getsug@cagents.com.

4. Materials and Equipment
     4.1. List all the tools and materials needed to perform the task. These may include torque wrenches, specific hand tools, rags, buckets, and machine parts specific to the task.
          4.1.1. Include all precision tools and equipment required to ensure precision techniques are applied.
     4.2. List any equipment specific tools required for the task such as rigging and lifting devices.

5. Procedure
     5.1. Procedures provide the necessary details and may be formatted to align with appropriate site-specific documentation.

6. System Turnover
     6.1. List all steps to be performed before turnover of the system to the owner. This will include removal of all LOTOs, closing out any permits, and ensuring all guards and other safety features that were removed during the course of maintenance have been replaced.
     6.2. It may also include pressure-testing fittings, starting pumps, and motors to ensure they are installed correctly.

7. Theory of Operation
     7.1. It’s strongly recommended to document the theory of operation supporting the work instruction or SOP. This provides in-depth description of how the equipment works and can be helpful when technicians are maintaining or troubleshooting the equipment.
     7.2. The information for the theory of operation will come from the operations manual or perhaps the OEM’s website. Some clients have a large collection of information on their websites dealing with their equipment and products. This can be a great source of information.
     7.3. This section can be placed either in the body of the SOP or as an appendix.

8. Definitions
     8.1. This section can be placed in the body of the SOP but is usually an appendix.
     8.2. List the definitions of all acronyms and technical terms used in the SOP.

9. List of Spare Parts
     9.1. This can be found in the turnover package or the results of an FMEA or RCM analysis. It can be of use to the purchasing department or maintenance personnel when ordering parts. It can be helpful when writing the procedure to obtain the proper name for the replacement parts.
     9.2. This section may be placed in the body of the SOP or as an appendix.

10. Roles and Responsibilities
     10.1. This section is typically client-specific to ensure the SOP or work instruction is properly used for maintenance. This section should document the owner of the document, individuals responsible for implementing the contents of the SOP or work instruction and any special requirements to accomplish the work.

11. Appendices
     11.1. The content of the appendices can vary significantly, and each client will have its input.
     11.2. One critical question is whether the appendices will be considered a controlled document.

12. Documentation
     12.1. Revisions including the date, reason for revision, and approval process must be managed and maintained. Often this is at the end of the document prior to the appendices.

13. References
     13.1. All sources of information used to prepare the SOP or work instruction should be listed in this section.

Summary

Patrick Wagner is a degreed biologist, whose background is deeply rooted in the sciences. Having begun his career as a validation scientist, his entrance into this regulated industry was one that allowed him to demonstrate his skill as a technical writer, pairing with his use of the scientific method to identify, to describe, and to mitigate risk in manufacturing environments. Wagner currently works on assignment at Eli Lilly, where he supports a portfolio of molecules in clinical trials as a clinical project manager. Wagner holds a B.A. in biology and Spanish from DePauw University and an M.S. in biology from Purdue University. Contact him at patrickwagner88@gmail.com.

Work instructions are written to provide concise instruction to the maintenance personnel, while ensuring regulatory compliance and meeting the unique needs of the pharmaceutical manufacturer. Work instructions should not, however, be viewed as obligatory documentation to be executed in addition to everyday maintenance activities; these detailed work instructions should instill a culture of inspiration with a focus on precision work. Precision tools and techniques that improve the technician’s skills and understanding of the work they’re doing should be integrated within the work instruction to cultivate this culture of inspiration within the facility. As procedure-based systems become more commonplace and regulatory demands veer away from craft-based maintenance programs, the inevitable consequence will be the development of these detailed, repeatable work instructions. Developed as part of a robust maintenance plan, work instructions, incorporated with technician training and appropriate analyses to define the system-specific critical maintenance activities, are fundamental in developing a successful maintenance program. In this highly regulated industry, work instructions lay the groundwork for precision maintenance, and, even in light of this tight control, work instructions may work to inspire those willing enough to follow.