Grace Periods in Calibration and Maintenance Intervals

Good morning Al,

I do not have a question about TrackPro. We are having an internal discussion here and I was wondering what your thoughts were. Do other companies allow for a grace period for calibration due dates. For example, the balance is calibrated every 3 months (+ 15 days). I have seen SOPs written both ways, but without justification or documentation we will not allow a grace period.​

As you might expect, I have an opinion about this and not being shy about my opinions I decided to share them more broadly.

I have seen SOPs written both ways also. However, this approach is uncommon in regulated industries such as Medical Devices and Pharmaceuticals. In my mind, it is a philosophical issue. The very word “grace” is the most troublesome aspect of this.

What is the reason for providing “grace”? If one needs an advance plan for being late, the implication is that one plans to be late a good deal of the time. Calibration and maintenance action intervals should be determined based upon previous experience and risk and not modified based upon convenience and poor planning.

If 105 days is an acceptable action interval as opposed to 90 days, then the interval should be extended to 105 days permanently. This should be done for business reasons alone. If a reasonable interval is truly 90 days then a good system should ensure that work is done as scheduled, Providing “grace” tends to obfuscate the primary intent of having action intervals in the first place.

In systems that provide a grace period, I find that virtually all actions are taken at some time during the grace period. Furthermore, since the concept of grace is institutionalized, there are higher rates of failure to meet specified intervals than in systems that don’t provide grace.

One must keep in mind that any deviation from a process requirement is a nonconformance, and in regulated industry, must be treated as such. It can be argued that the very act of providing “grace” is a deviation from normal process and thus a nonconformance worthy of Corrective Action Preventive Action.

So, in summary, the concept of grace is a wonderful thing, especially as related to unmerited divine assistance or the three sister goddesses of Greek mythology who are the givers of charm and beauty. However, the concept of grace has no place in regulated industry.

 

I agree, this is a system that will be abused. Give an inch and take a mile. If a calibration is going to be late, then do it and file an internal CA.

 

Nope. Nothing wrong with being a day late in the real world. In reality how many times do you find something out of calibration. In most instances a grace period is perfectly fine.

 

We plan to achieve a success and at the end sometimes we fail. When someone plans to fail, definitely shouldn't expect to achieve success.
It is good to know company's personnel attitude when you are stakeholder.

 

I agree, you might be at the liberty of the capacity of the test house whom might have a 2 week backlog. If you use a s/sheet to monitor drift on equipment, you can (in my opinion) track any movement in calibration and if a grace period is hurting you. I would 5% of the cal certs I receive need a slight amendment and this grace period should catch those. rgds

 

I work in the Pharma world, the Company I work for has hundreds of thousands pieces of equipment that require either calibration or PM service, on top of any corrective work orders that come in throughout the day. We don't call it "grace periods", we call it PM or PMCal windows. Typically the PM window is 30 days to get the PM completed. Depending on the PM interval, i.e. 30-day, 60-day, 90-day, 180-day or 365-day, the work order will hit the Planner/Schedulers computer anywhere from 30-days to 90-days before the first day's scheduled start date. Our Crews will have an "start date" and an "finish date" that they work to. The PM can not go over the "finished date", we have metrics that we have to adhere to and are measured against. Depending on the date the PM was completed, the next due date will auto-adjust to the next date established by the PM interval. We ware constantly being audited by agencies, this hasn't been an issue with in any audit.