duction lines are ramped up, new HPMs are added to the
research or manufacturing underway at your facility, and
new regulations are adopted, what you know today won’t
be true tomorrow. Never assume you know – always double check. “Only asses assume” – don’t become a donkey.
3. Don’t be shy, get help
The constantly shifting sands of HPM management –
fueled by the dual challenges of evolving production processes and changing regulatory requirements – make the
challenge of keeping current almost a full time job. Don’t
be shy; develop a strong relationship with a consulting engineer you trust and use that person consistently.
This is one area where keeping your consulting engineer on speed-dial is a smart move. And make sure your
speed-dial directory includes your engineer’s cell number.
HPM driven problems can erupt at any hour.
There’s a business strategy to outsourcing this initiative
as well: it’s called shifting the liability. By shifting, and
clearly delineating the responsibilities to your consultant,
a significant amount of professional liability will reside
behind the professional engineer’s seal.
4. “It’s not Operations’ job”
Don’t assume that the professionals in manufacturing
operations understand the regulations. Their job is to get
the product manufactured, and you may often find yourself caught between the rock (manufacturing) and the hard
place (regulatory requirements). You will have days when
Operations needs X quantity of an HPM yesterday, and that
quantity exceeds allowable limits. An order from Operations
is not infallible. Deadlines purported by Operations or pressure from end customers are not reasons to by-pass the rules.
5. Maintenance is Job #1
Think Bhopal. A side pipe missing its slip-blind plate?
Corroded, non-stainless steel pipes? An out-of-order
steam boiler? These are the everyday things that nightmares are made of.
6. Education must be current, comprehensive, and constant
HPMs carry too much risk to skimp on education at all
levels of the organization – from management to the new-est manufacturing team member. Develop a program, in
concert with departments as appropriate to your organization, and diligently drive its execution. Depending on your
organization, departments that should be actively involved
in developing your education program may include operations, finance, health & safety, security, communications,
and legal. You may need to call in outside experts and
thought leaders to fill the gaps – don’t hesitate.
7. Document, document, document
The documentation of HPM handling and usage is
highly regulated and must be executed in a timely manner.
Your work plans must place a high priority on this effort.
8. Top-down advocacy is critical
The president/CEO and the board of directors must be
advocates of proper HPM handling, and ongoing facility
maintenance. If they aren’t, I’d suggest a career change.
Sound HPM management is, in one respect, everyone’s
business. But the facilities engineer needs to step up and
ensure all aspects of this challenge are addressed.
Richard Bilodeau, PE, is director of engineering at SMRT
Architects and Engineers ( www.smrtinc.com). His 30 year
career includes plant engineering positions in clean manufacturing. Richard has engineered, designed, operated, and
supervised the construction of numerous controlled environments and labs for advanced technology, life sciences, industrial, healthcare, academic, and corporate clients. Dick can
be reached at: firstname.lastname@example.org or TheFacilitiesGuy@
9 September 2014 • www.cemag.us 27
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