Oct 13, 2013

Excellence in Equipment Documentation

Penelope Trunk has an interesting post on Jake Breeden's Tipping Sacred Cows which lists sacred cows in corporate life that we should reconsider:

Balance: Disguising indecision as a bland compromise that attempts to achieve many things but ends up accomplishing nothing
Collaboration: Creating a culture of learned helplessness with little individual empowerment and accountability
Excellence: Spending too much energy producing perfect work instead of developing the quick-and-dirty solution needed now
Fairness: Keeping score and evening the score to make sure no one gets more than their “fair share”
Passion: Racing down a path seeking success only to find burn-out and misbehavior instead

I think Excellence is a controversial sacred cow, so I wanted to use an example from my medical device factory.  We have a comprehensive equipment program, whenever you have a piece of equipment it will take you at a minimum two to three weeks to get it qualified.  The two to three weeks process time applies to off the shelf equipment we probably already have 15 of that we're already using. 

21CFR820.72 and 21CFR820.70(g) cover equipment requirements, 820.72 is mainly calibration, 820.70(g) is as follows:
(g)Equipment. Each manufacturer shall ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use.
(1)Maintenance schedule. Each manufacturer shall establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met. Maintenance activities, including the date and individual(s) performing the maintenance activities, shall be documented.
(2)Inspection. Each manufacturer shall conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules. The inspections, including the date and individual(s) conducting the inspections, shall be documented.
(3)Adjustment. Each manufacturer shall ensure that any inherent limitations or allowable tolerances are visibly posted on or near equipment requiring periodic adjustments or are readily available to personnel performing these adjustments.

These requirements can be summarized as the equipment must be sustainable and qualified.  These requirements can generally be satisfied by information in the equipment manual and the process testing that you have to do anyway. 

However, as mentioned above, at my work we go far beyond the requirements, we must release a custom drawing of the equipment, custom maintenance procedure and form, - this information is in the manual, but we like to copy it into our own forms.  All of these are held to the internal standards, even though they are absolutely worthless, if I want to do any maintenance work on the equipment, I'm going to reference the manual, not the drawing an engineer threw together to meet a requirement.

A software evaluation must be completed even if the equipment obviously has no software, along with forms for installation qualification (IQ) assessments: line voltage, environment, EMF, safety, calibration, etc.  While it is necessary to perform and document an IQ, the company culture has developed tribal knowledge requirements to do so, if you don't justify the need to not validate the non-existent software properly, well you'll just have to do it again, of course the templates contain no guidance on these.  You can't justify out of measuring line voltage even though your soldering iron clearly works fine.  Operation qualifications are sometimes performed when only installation qualification is needed because justifying out of them has become difficult.

At all steps you need appropriate sign offs, which generally consist of four or five people.  While this is someone's version of excellence, it really accomplishes nothing that isn't included in the manual for an off the shelf piece of equipment. 

A review of warning letters from the FDA reveals the most common issue with equipment is not performing required preventive maintenance or calibration.  In fact, as far as I can tell, no one has ever been cited for not finding a calibrated volt meter and checking the voltage before plugging a piece of equipment in.

All the time making excellent equipment documentation is time spent not working on further understanding of the production process.  If you're spending your energy on getting approvals for a drawing you made of box oven #12, then you are not improving something meaningful.  


Unknown said...

Awesome blog on medical equipment and supplies Thanks for posting!

Unknown said...

I agree with you. Spending more time on documenting the equipment, the better outcome you will have. You need to know what your documentation needs to consist of, and work with it.

Wayne. | http://www.regencyrx.com/en/

Medical supplies online said...

Documenting is one of the vital part of any equipment, effective & easy to use documentation will help people to easily utilize it to get best output.

Unknown said...

Thank you for sharing. I found this post to be very informative and helpful.
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