We understand the tension. You get it … we all want to be process focused. Create and maintain a good process, and good outputs will come forth. But you may be the one that faces the auditor or faces the inspector. They ask for evidence that the process was performed. You think, “life would be much easier if I just had a document or record to show them.” So when deadlines approach or milestones are coming up, we can gravitate toward a document and/or record approach to our quality management processes.

Often non-value added documents and/or records can begin to accumulate. The team recognizes it. The very evidence meant to show “good” process is now robbing scarce time from the team. No one wants to remove the evidence requirement from the process – even though all agree it is non-value added. The overall process lacks sufficient metrics so that you could actually measure whether the activity, when removed, has any impact on product quality.

Sound familiar?

Let’s right-size and benchmark our #qms against #iso13485 and related process standards. Let’s use product quality risk to identify the controls (and metrics!) we need to create both effective and efficient processes. You’ve got this. If you would like a jump start or help, let’s talk.

Need training?  Consider our live, 3-day ISO 13485 Internal Audit(or) Training Course. Email training@softwarecpr.com for price quotes and tailoring opportunities.