Re: Calibration grace period
Today, I received the following query via email from one of my TrackPro customers.
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.