Calibration  7.6

Revision: 4/16/2009

NOTES (in support of the flowchart on page 1):
1. Company owned monitoring/measurement devices (things needing calibration or verification) are maintained by quality and employee owned devices are maintained by the employee. The Calibration Schedule is maintained by Quality. New monitoring/measurement devices are brought to Quality's attention when they arrive to determine if the device needs to be calibrated or verified prior to use (may simply accept the vendors cert if the cert provides insight into the calibration and maintains traceability). Employees are responsible for informing quality of new devices so they can be added to the Calibration Schedule. When pulling the device for calibration/verification, check to make sure it is being protected from damage or deterioration and has not been tampered with (safeguarded) in a way that could affect the device’s ability to provide accurate results. A calibration may be extended if the device has not been used since the last calibration or there is evidence showing use has been minimal. The extension and a justification would be included in the calibration record.
2. We have used them before and no problems were encountered (see the Purchasing procedure).
3. Those providing calibration/verification are selected (criteria) on the basis of price and their ability to deliver. Evaluation criteria is simply that they are able to trace any calibration/verification performed back to NIST or other standard bodies and the standards have a capability that is greater than our tightest tolerance. The record of evaluation is described in the Purchasing procedure.
- Outside Service - device is returned in a condition reflecting protection from damage or deterioration during calibration/verification and a review of the calibration/verification record provided by the supplier shows the device passed with traceability reflected and status (label on device or serial number that can be tied back to the record) clearly understood.
- In-house - calibration/verification using traceable standards found the device to be in tolerance.
Even if the device is within tolerance, we may choose to adjust or re-adjust the device to tighten the tolerance. The person performing calibration and/or the vendor working to calibrate the device would simply adjust/re-adjust the device and complete the calibration.
5. Devices that have been calibrated or verified may be labeled as such, but may be uniquely identified (i.e., name or number on the device) to allow for verification of status against the records. All devices are protected from damage or deterioration during handling and storage. This is also where we make sure settings that can be adjusted are safeguarded (tamper-proofed, sealed, etc.) to prevent tampering, when necessary. Records of the results of calibration/verification (internally and externally generated records) are maintained, include traceability, and are filed per the records section of the Master Control Plan.
- Is the device worth fixing (cheaper to repair than replace)?
7. If the item can be repaired (including adjustment/re-adjustment) in a cost effective manner (cheaper to repair than replace), it is repaired and re-calibrated/verified if it is such a device. Otherwise, the device is removed from service and a determination is made whether to purchase a replacement. An impact assessment (determining whether the device is out of tolerance within a range affecting our use of the device, review of customer complaints to see if an impact was realized and/or monitoring/measurement of product already checked with the device in question with a known good device) is undertaken by Quality (with employees responsible for notifying Quality when this condition occurs on employee owned devices) to determine the validity of any measuring or monitoring done with the device. The results of this impact assessment are recorded on the calibration record. The assessment will include any action taken on the equipment or affected product, as necessary.
8. In-house calibration/verifications are done per manufacturer’s recommendations or per check methods established by Quality (embedded in or referenced by the calibration record). The combination of these methods and ensuring traceability to NIST or other standard bodies is the process employed and is included in the calibration record.

Determining monitoring and measurements to be undertaken, the devices needed, and ensuring the monitoring and measurement processes are fulfilling requirements (7.5.1d, 7.5.1e & 7.6) - Determination typically based upon the experience of the person performing the monitoring or measurement activity (see Position Guidelines), but may be made by Quality or management as part of inspection or test procedures or work instructions and/or process specific procedures or work instructions.

Traceability of calibrations or verifications to NIST or other national/international bodies (7.6a) - All of the calibrations or verifications done at Pi-Co are traceable to the National Institute of Standards and Technology (NIST) or other standard bodies, as applicable. When there is no standard, the basis for the calibration or verification is recorded in this procedure, process-specific work instructions, and/or as part of the calibration record.

Confirmation of software (7.6) - Software used for monitoring or measurement will be confirmed if and when software is involved in monitoring or measuring of processes or products and would be reconfirmed as necessary (see applicable calibration record).

The little numbers shown throughout this document are clause numbers from ISO 9001:2008 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Evaluate and select" box with "7.4.1" referenced. This means the notes or documents referenced, address the requirements of 7.4.1 of ISO 9001:2008.