Welcome to Maintenance Mindset, our editors’ takes on things going on in the worlds of manufacturing and asset management that deserve some extra attention. This will appear regularly in the Member’s Only section of the site.
Manufacturing job seekers are losing their leverage as market softens in 2024
There’s been a LOT of news since the last time we published Maintenance Mindset, but I still want to comment a bit on the news coming from John Deere that they plan to lay off 600 employees from three factories in the U.S. as part of planning for a new facility outside on the United States, in Ramos, Mexico.
News from John Deere often hits close to home for me. I live in Chicago, and the John Deere factories that are being impacted are located nearby, in Dubuque, IA; Davenport, IA; and East Moline, IL. Each of these are proud factory towns, and are places where industrial job losses are not easily replaced or backfilled. In fact since the start of 2024, John Deere has announced more than 1,500 layoffs in Iowa alone, citing a 16% drop (or $6 billion) in Q2 net sales year over year for the company's production and precision agriculture segment.
I was surprised at this news seeing as how it seems to run contrary to the positive jobs report for June 2024 that included 206,000 new jobs added in June, along with so many people entering (and re-entering) the job market that U.S. unemployment actually grew from 4.0% to 4.1% in June. The most telling charts, though, indicate that manufacturing jobs at the moment may be plateauing at 13 million, and that machinery manufacturing is apparently entering the downward part of its employment cycle after peaking at about 1.14 million workers.
– Thomas Wilk
A lot riding on equipment maintenance
The U.S. Food and Drug Administration (FDA) recently reprimanded a large pharmaceutical company for maintenance activity violations related to the Current Good Manufacturing Practice (CGMP) regulations. This took place at one of the company’s facilities in Dadra, India, where FDA conducted inspections from Dec. 4 to 15, 2023.
In June, the FDA letter said the “firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).”
For example, investigators observed 450 mL of stagnant liquid within a specific piece of equipment, directly used in the manufacture of drugs, and chemical tests indicated yeast and mold, among other microbiological no-nos.
All pharmaceutical companies test their products, and certain investigations must be completed for out-of-specification (OOS) tests, meaning a test result falls outside of the specifications or acceptable criteria established in drug applications. The company has also been reprimanded for poor root-cause analysis investigations following the FDA inspections late last year.
In its initial response, the company stated that a faulty valve was the root cause for the stagnant liquid. The valve failed to completely close and seal when it was last disassembled on June 26, 2023. The company discovered this equipment malfunction after the FDA inspection, and batches between June 2023 and December 2023 were recalled.
However, the FDA warning letter said it doesn’t think that’s the full answer and continues to call into question cross-contamination issues. The unknowns from the initial chemical analysis still need investigation “to prevent recurrence of inadequate equipment maintenance,” the warning letter said.
“It is your responsibility to ensure your equipment maintenance program is comprehensive and includes appropriate assessment of equipment failures and their impact to product quality,” it continued.
The company will be given a chance to remediate these actions with a thorough assessment and improvement plans. A corrective action and prevention action (CAPA) plan will include remediations and timelines for completion, a detailed summary of process vulnerabilities for equipment cleaning lifecycle management, cleaning program improvements to enhance cleaning effectiveness, and improved ongoing cleaning execution verification.
The FDA’s Current Good Manufacturing Practice (CGMP) regulations ensure the quality of drug products and set up minimum requirements for methods, facilities, and controls. The approval process for new drugs includes a review of manufacturer’s compliance with CGMP. This includes sections on maintenance building and facilities maintenance, equipment cleaning and maintenance, and equipment identification standards and recordkeeping.
I think it’s interesting to note that the standards are very general, rather than specific. In general, it depends on what drug is being manufactured, and as the standard above notes, equipment shall be maintained “as appropriate” and “at appropriate intervals.”
Those details and specifics are worked out before drugs are manufactured and marketed, but there seems to be some room for adjustments. But it could be an expensive endeavor after the fact. Not only did the company recall six months of drug production, but also after the latest FDA wrist-slap, the company’s stock fell 1.9%. Maybe not that much, considering? And the company’s latest Q4 and FY24 financial report ending March 31, 2024, reported 10% growth in gross sales, including $476 million in U.S. sales, and 27.8% growth in adjusted net profit.
That’s sure a lot of zeros riding on equipment maintenance.
– Anna Townshend
Turning plastic trash into Olympic gold
Imagine. You’ve been practicing and training for years, no, decades, with the hopes of competing in the Paris 2024 Olympic Games. And just like the protagonist in an inspirational movie, you overcome the odds, make it to the event, and even place in the top three. You could not be prouder as you wave to the crowd, the prestigious medal hanging from your neck, as you stand atop a podium made of trash.
Well, not exactly trash. The podiums that will be used at the 2024 Olympic Games and subsequent Paralympic Games are made of recycled plastic. Despite their humble origins, these eco-friendly podiums are as beautiful as they are sustainable. The podiums are gray, reminiscent of the rooftops of Paris, with Eiffel Tower-inspired design work on the fronts.
And that’s not all. According to Reuters, 100 tons of recycled plastic has been used to create bleacher seats for two arenas that were built specifically for the Olympics. The 11,000 seats will be used in the Adidas Arena and the aquatic centre.
The company behind these green creations is Le Pavé. In a recent article for The New York Times, author Liz Alderman wrote: “Just a few years ago, the company had only three employees. But an unexpected call from Olympic organizers led to a beefy contract, and the company has expanded to a staff of 34 and opened two factories. In the process, it has become a poster child for the Paris Olympic committee, which has pledged to make these Olympic Games the greenest in history.”
So, how does Le Pavé turn trash into treasure? According to the company’s website, they use a combination of post-industrial and post-consumer plastic waste to create large plates of material that can be easily sawn, drilled, chamfered, and sanded. This material can then be used as wall coverings, baseboards, countertops, furniture, and more. To achieve its signature material speckling, Le Pavé carefully blends the colorful plastic chips before using customized machines to heat and compress the material, according to Robert Grace for a recent Plastics Engineering article. The compressed and molded panels are usually black or white with colorful flecks throughout.
To make the Olympic project possible, Le Pavé had to collect a lot of plastic. According to Atharva Shetye for The Sportz Planet, the company partnered with 50 recycling companies to obtain the necessary plastic, and even enlisted 1,700 children to collect bottle caps.
In a recent quote, Paris 2024 President Tony Estanguet said, "We are pleased to reveal the podiums for the Paris 2024 Games, whose design follows the path of our medals with a piece of the Eiffel Tower within them, inspired by the lines and curves inspired by the work of the great French architect Gustave Eiffel.”
He added, "With these podiums made in France from French wood and 100% recycled plastic, we offer athletes a real stage where they will be proud to stand and wear the colours of their country, watched by the whole world."
– Alexis Gajewski
