How a Pharmaceutical Plant Cut Loader Downtime by 74% With Root Cause Analysis and Training

Three problems sat behind the reliability numbers at this pharmaceutical facility: premature failures, a knowledge gap, and a Root Cause Analysis process that never got past the surface. This is the reliability engineer’s account of fixing all three, written as part of Eruditio’s Inspired Blended Learning® program.

Strategic Alignment of Operational Reliability

When I first started on this journey to improve loader reliability, I had several areas of interest: premature failures, lack of knowledge, and improper Root Cause Analysis (RCA). I took all of it into consideration in trying to make the loaders more reliable.

At the same time, I was leading the Reliability Engineering team here at Company X, working to establish criticality, FMEA, hierarchy, RCA, PdM technologies, and failure modes. All of it fed the loader project. In reliability, everything has to work together to be successful. If you have one without the other, you will fail.

The Improvement Process

The first thing I looked at was building a true RCA process for premature failures. I assembled a team, which we called the Loader Rapid Action Team. We started out taking care of small failures and getting quick fixes for an easy win.

I was receiving daily reports on the truck loaders from our Computerized Maintenance Management System (CMMS), and I noticed we were breaking a lot of chain dogs, lift jaws, and Love Joys. There had to be an underlying issue causing all of it.

Until that point, we had never had a true RCA process. We only had the basic 5 Whys. That process is great for pushing your thinking in the right direction, down to the physical failure mode. But it does not get down to the systemic and latent issues.

I led my team through a fault tree RCA, starting with the chain dog. Working through it, we found four contributing causes:

• External force from improperly loading the trucks
• Improper chain dog size
• Improper installation of the chain dog
• Truck PMs not being completed (the latent issue)

The truck PMs weren’t being completed because crews were rushed to get product out the door, and because some people believed the PMs were unnecessary and a waste of time.

That last finding matters more than it looks. If you give people direction with no explanation, they will never see the value in the task, and it will ultimately not get done. What we had was a training problem. I presented the case to the leadership team, and we held supervisors accountable for making sure the truck PMs were completed.

Building the Foundation: Criticality, Hierarchy, and FMEA

When I started leading Reliability Engineering, Company X had nothing established for criticality, FMEA, or RCA. The 5 Whys was the only RCA process in place, and it existed mainly to get people thinking in the right direction. We already had hierarchy and failure modes in the plant, but with little knowledge of how they worked or how to access them.

We took the criticality tool first, because it is used by the planners, the stockroom, and the reliability engineers. Criticality drives FMEA, RCA, planning and scheduling, and kitting.

It’s important to understand what a criticality tool actually does. It ranks the most critical assets. It does not tell you which assets are most important. All equipment is important, especially the piece that’s down right now. That distinction is where your thinking has to change.

The tool we built weighted a range of impact factors, aligned to what matters to a pharmaceutical company:

Safety Impact — 30%

• Injury potential in the event of failure
• Fire/explosion
• Injury potential during maintenance

Maintenance Impact — 25%

• MTBF
• MTTR
• Asset maintenance cost for one year

Quality Impact — 20%

• Major maintenance required after repair
• Asset calibration requirements

Operational Impact — 15%

• Asset impact on other areas of plant production

Environmental Impact — 10%

• Air emissions
• Chemical spills

With the criticality tool established, we reviewed the existing hierarchy and failure codes to see whether they would meet our needs as a reliability engineering function. The problem with any hierarchy is setting it up so that it satisfies both accounting and reliability engineering. It always seems to lean toward one or the other. Our CMMS failure modes were suitable for a first phase.

Then came FMEA. We decided to cover the top 5% of the plant’s most critical assets. When we built the criticality tool, we ran all 321 assets in our pilot area through it. The Automatic Truck Unloaders (ATUs) rose to the top as most critical, which made them the best bang for our buck. All the ATUs are roughly 90% similar in function and components, so from a single FMEA we could apply the updated maintenance plan, RCA findings, and training across every unloader in packing. FMEA is a long process and it takes a lot of work, but the payoff is well worth the time.

Results

We started sending reports mid-month so supervisors could see how their lines were tracking on truck PMs. Truck PM completion went from roughly 20% to 100% every month.

We implemented PM training during the process and began measuring.

	Jan–Jun 2017	Jan–Jun 2018
Total loader downtime	277.5 hours	71.99 hours
Downtime from chain dogs, lift jaws, Love Joys	109.62 hours	17 hours

From those findings alone, we saved the company $137,986.44. That figure doesn’t account for what the company sells the product for out the door. It’s the savings in filling alone. Altogether, the RCA and the training program saved the company a total of $306,171.

This is what a reliability department does for your output and your equipment uptime. Establish a true RCA process and real accountability, and you will see results. The RCA, combined with proper training of the handlers, is directly reflected in loader reliability. With proper training also comes ownership of the machine. If handlers own the equipment and understand how it should operate, they will tell you before there’s a major failure. Operations is always the first line of defense.

Sustainability

Up until this point, training was handed off from one handler to the next, on a “well, this is how I was shown to do it” basis. There was no set standard for properly loading trucks. We made a training video on correct loading procedure, and it is now part of the operator’s yearly training.

Through past RCAs, training had become a one-time event. It was never established as ongoing and job-related. Making truck PMs and proper loading procedures part of annual training ensures people stay aware of the correct procedures. Once people are aware of the proper procedures, then you can start holding them accountable.

We also put in place the PT2 (Production Technician Level 2) training program, which pairs PT2s with the machine subject matter experts alongside formal coursework:

Production Technician Training Program — Phase 1

Classroom	Est. Course Length
Electrical Safety / LOTO	4 hr
Electrical Drawings and Symbols	2 hr
Basic Electrical Components	1 hr
Pneumatic / Hydraulics Lab	3 hr
6-S / Lean / TPM	2 hr
Proxes / Photoeyes	1 hr
Maximo	3 hr
DC/AC Electrical Training	12 hr
Basic Electrical Troubleshooting	3 hr

Tech-Led Training	Est. Course Length
Machine-Specific Training	Avg. 2 hr

ISO Train CBT
Abnormality Identification
Maximo Service Request Training

The PT2s took the time to learn the order of operations on the unloaders and to build relationships with the mechanics, technicians, and lead operators. They came away feeling real ownership of the equipment, and comfortable enough to ask questions. That’s now a permanent part of the PT2 program. It’s early, and it has already shown tremendous success. When someone is awarded the PT2 position, they begin these courses. To be successful, you have to invest in the employees.

Learning From This Journey

As we continue toward world-class maintenance, we will continue to see improvements. The improvements already made speak for themselves. Let the tools of reliability and the payoff speak for themselves. It’s a continuous improvement process, and if we stay on this journey, we will continue to be successful.

One thing I wanted to pass on to everyone: we are all one team. We have to work together if we want to be successful.