Out of Tolerance Reporting ‘A Ticking Time Bomb’ Walter Nowocin Medtronic, Inc. /Minneapolis, Minnesota NCSLI Nashville, TN 15 July, 2013
Objectives n Discuss value of Out of Tolerance (OOT) Reports n Review a ‘business example’ of an effective OOT Reporting process
Value of OOT Reports n Out of Tolerance Reports are used to communicate to instrument owners any out of specification condition found during a calibration process n What are the typical data elements identified in an OOT Report? n What are other valuable benefits of an OOT Report?
The ‘Hidden’ Value n Recently reviewing several returned OOT Reports for administrative completeness and quality investigation and rationale conclusion. n Additional review in our equipment database seemed to bring up additional questions. n Ultimately my ‘light bulb’ went off and I came to the revelation of another benefit or ‘value’ of OOT Reports – they provide a great insight and overview of how well your processes are doing. n The OOT Report by its very nature is the worse-case calibration or measurement process. n Normally associated with an issue on the customer side n Revelation – can be associated with an issue on the calibration side n And can be both!
OOT Philosophy n There are several ways to look at ownership of the OOT Reporting Process n n n Initiator – only generate the report. Other entities resolve and file the report and own the metrics; i. e. QA, Engineering, etc. Administrator – generate and file the report. Other entity is solely responsible for the content and sign off. Metrics can be owned by the calibration lab or by the QA/Engineering group or both. Ownership – generate, file, and provide administrative and content review and own the metrics.
Ticking Time Bomb n n Back in 2002, our OOT process was a manual process and our investigation requirements were too basic and insufficient. This area was our highest risk to not being in compliance. I dreaded that the next audit would expose us of our deficiency – a ticking time bomb. Perfect timing – we were in the process of replacing our calibration database system. The time was right to stop the ticking!
Improvement Steps n We automated our process n n Auto-generated and e-mailed to the customer Auto-generated a ‘OOT Report Due Notice’ to the customer Past Due OOT Reports went from over 30 reports past due by more than 60 days to less than 2 reports past due by 7 days We worked with our internal auditors to enhance the investigation portion of our OOT Report template
n. Before: n. Impact Statement: ______________________
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Conclusion n OOT Reports have value in many ways, not just for the customer. When improving a quality process leverage the expertise of your internal auditors – they know what to look for, so they know how to avoid those situations Take ownership of the OOT Reporting process – stop the ticking
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