Our calibration procedure is just a couple pages long and makes general statements about how we handle calibrations on various equipment in the plant and lab - who schedules them, who reviews them, what kind of documents we require, what to do if something is found to be out of calibration, etc. We then have a spreadsheet listing each piece of equipment, model and SN, where it is located, what it's function is, whether it is an internal calibration or external calibration, date of last calibration, due date of next calibration.
Below is an excerpt from our SOP which discusses doing a risk assessment when something is found to be out of calibration:
- If a piece of equipment is found to be out of calibration:
- The equipment will be re-calibrated as soon as possible. If not possible to re-calibrate immediately, the equipment will be taken out of service.
- The Maintenance Manager, Quality Management, and the Plant Manager will be notified.
- A risk assessment of potentially affected product will be done, going back in time to the last good calibration. The assessment will be done by the Quality Management, Maintenance Manager and Plant Manager.) The purpose of this evaluation is to determine if further action is needed (product put on hold, etc.).
- The risk assessment will include consideration for the following:
- What the equipment is being used to measure.
- How far the calibration is out and how significant the impact is.
- Does the equipment monitor or measure a control point or regulated characteristic?
- Review of previous calibration records for that equipment –internal and external.
The discussion here so far has been related to a metal detector (CCP), but there may be other equipment you need to consider. Many of us already have clearly defined actions to take when the metal detector is found to not be working properly (when a test piece fails) such as: stop the line, put product on hold back to the last good check, repair or replace the detector, can re-run product on hold through a work MD at later time, etc.
However, there may be other equipment in the plant or lab that gets calibrated such as weigh scales for example. When an outside service comes in once a quarter or once a year to calibrate them, and they find a scale out of calibration that you use to weigh ingredients, products, other... this is when a risk assessment needs to be done. It's possible that scale has been used for an entire quarter, or entire year and wasn't giving accurate weights. What is the significance of that? That depends on how far it was off, what it is used for, was it reading too low or too high, etc. The risk assessment should be documented with the answers to the those type of questions, and your conclusion as to if product is at risk or not.
This has been my experience with that part of the standard, and I hope you find this helpful.