Experience
Audit Finding Leads to Improved Performance
Following an audit finding of non-conformance, we were able to implement a new business process and not only assured compliance but also improved overall efficiencies.
The Company was undergoing its annual ISO 13485 surveillance audit with a representative from one of the major registrars. These audits happen annually following initial certification with each third audit for recertification. During surveillance audits, the auditor is examining a subset of the standard to verify compliance. As always, compliance must be proven with objective evidence.
In this particular audit, the area of question was purchasing and receiving. Specifically, the auditor was seeking objective evidence that items purchased were inspected properly. This evidence simply needed to be accompanied by proof that the individual doing the inspection recorded the outcome in some way along with the date.
However, while the procedure clearly stated how incoming inspections were to be documented, no evidence could be found other than an undated, uncontrolled spreadsheet. A minor non-conformance report was issued.
Using the "Five Whys" technique, we performed a root cause analysis to determine where the process had fallen short and why. It did not take us long to realize why this issue was allowed to occur. As it turns out, the evidence of the inspections was located. As the process dictated, inspectors were sending emails to the purchasing department (in another state) whenever items passed inspection. These emails were not accessible to the quality manager and thus unavailable during the audit.
The root cause analysis also showed that the current process was overly complex. The process of purchasing, ordering and inspecting incoming items was performed by several individuals across two facilities with every step taking place via email. Many time steps had to be repeated because individuals had overflowing email in-boxes and failed to see their action was needed at certain steps. As a work around to perform tracking, the group being audited had developed the spreadsheet for tracking so they could determine what orders had been placed and received.
The solution was elegant and simple. We found a third party web-based application that could manage the purchasing and receiving process. This system would automatically interface to the company's existing ERP system and document each step automatically. Not only did the new system provide the necessary objective evidence of compliance to the standard, it was much simpler to use and involved fewer steps and fewer people. Because the new system was so much easier to use, the employees were better able to follow the process each and every time.