Continuous Improvement programs are not just for the manufacturing groups or departments we typically think of that produce, package, and inspect the product. Maintenance’s role is to ensure all the production, support equipment, and utilities needed are in working order. Additionally, they are responsible for ensuring any rated clean rooms have the proper air flow/quality, they meet their water quality standard, and ensure sufficient clean compressed air at the source for equipment, fixtures, or parts cleaning is available. All of those responsibilities and more play a role in helping to reduce scrap, decrease product lots on hold, and diminish lost hours due to equipment downtime.
Before starting a new Continuous Improvement program, the current state versus the desired state of the Maintenance Department should be considered. This includes their inventory control for replacement parts kept on site. Is it orderly, or does ‘I hope I can find one’ sound too familiar?
How about your 6S program? “What program?” would be the incorrect response. All production and production support groups should first be involved and actively engaged in a 6S program. (Sort, Set in Order, Shine, Standardize, Sustain, Safety) If the production operators don’t have their tools at or next to their workstations, clearly labeled or staged on shadow boards, I would not suspect the maintenance group to be better organized than production areas. If they are, great. Maybe a quick Gemba walk (personal observation of work – where the work is happening) would be in order. (Safety concern is a recurring theme for maintenance areas in my experience.) A good example though for other departments if everything checks out.
What about the documentation system that maintenance needs to stay compliant with FDA, ISO, and EH&S requirements? Are you proud of it? There is two basic type of functions they are involved week in and week out. First and typically the largest part of their function, are Planned Maintenance or Preventative Maintenance (PM) activities. They consist of looking at each piece of support equipment throughout the site that relates to production, inspection, storage, cleaning, packaging, facilities, and so on to complete maintenance at pre-determined intervals for items ‘A, B, and C’. When they are completed the maintenance activities need to be documented (or it didn’t happen in the eyes of the FDA). If something was found that needs to be repaired or replaced, this also needs to be documented. Someone should also review the completed PM to ensure all the areas that require inputs were filled out or checked. Next, a system to file the information and also one which is easy to retrieve to look for trends is needed. Systems with slow to impossible data gathering methods to look for trends in completed PM’s are not the first choice of regulatory bodies, as you may have experienced during on-site audits. Electronic maintenance software would be my recommendation. It not only helps with retrieval by equipment part number but can help schedule the month or week for upcoming items so they don’t go overdue per your in-house procedure.
The second type of activity maintenance support is a Maintenance Request (MR) or Repair Order. These orders vary greatly in the type of problems that need attention. When a production piece of equipment goes down, a form is initiated to tell the maintenance group of the issue, and should also reflect the priority needed for response time. This repair now becomes part of the equipment history and needs to be filed and retrievable just like a PM order mentioned above. The goal is to have the least amount of repair orders as possible, as they are reactive in nature and can disrupt the proactive PM process, which has a ‘window of opportunity’ once it is released to be completed on time every time.
Now, if your site has all of the items discussed above in place, documented, and audit tested, your maintenance group should be ready to do their part. This can include helping to increase production uptime, making layout suggestions so new equipment or modified production processes can be properly documented for PM’s, repair parts ordered and inventoried, and IQ validations completed (if required). Congratulations!