In this blog, “A Medical Device Complaint Management Auditing Approach,” the author focuses on the benefits of utilizing the 7-step process approach.
Auditors typically focus on the requirements of how to handle complaints, but what do you do with complaints after the investigation? If the only reason why you “handle” complaints is that it is a requirement, you are extremely unlikely to gain product benefits from reviewing complaints.
Are you using an audit checklist to verify that your complaint handling process is compliant with the regulations and that your records include all eight requirements of 21 CFR 820.198(e)?
Audit checklists encourage auditors to ask close-ended (i.e., yes/no) questions. For example:
- Did you document your investigation?
- Did you document corrective actions taken?
The Process Approach
The process approach to auditing is a seven-step process where the auditor interviews the process owner and individuals performing the process being audited (http://bit.ly/Process-Approach-Blog):
- What is the process?
- What are the inputs to the process?
- What are the outputs of the process?
- With what resources is the process performed?
- With whom is a process performed?
- How is the process done?
- Which process metrics are important?
Each step of the process systematically gathers information about the process. More importantly, however, the process approach identifies how the process being audited interacts with other processes. Evaluating the effectiveness of linkages is one of the primary benefits of the process approach. For example:
- Which records are used as inputs to the complaint handling process?
- How many corrective actions were initiated in response to complaints?
Sometimes, an auditor using the process approach will find a “broken link.” If there is no connection between the servicing of devices and the complaint handling process, this is a link that needs to be “repaired.”
The Most Valuable Step
Of the seven steps to the process approach, the last step frequently provides the most proactive suggestions for process improvements. The final step is when the auditor asks the process owner, “Which metrics do you gather for this process?” Often, this question is met with a blank stare. If the process is not being measured, then the process owner cannot proactively make adjustments before mistakes are made. Instead, the process becomes reactionary.
A reactionary process for post-market surveillance and monitoring of complaints allows the number of complaints to increase and cause additional problems. Therefore, each complaint should be categorized, and data analysis should be performed. Ideally, each complaint category should have a maximum threshold established for the frequency of complaints and the severity of complaints. The frequency and severity would be documented in your risk management file. You may even establish quality objectives for the length of time it takes to process complaints and the number of actual complaints.
Adjacent Link Auditing
Adjacent Link Auditing is an extension of the process approach to auditing. The principle behind Adjacent Link Auditing is that each process has adjacent processes in the process workflow. The process owners managing the previous process step (i.e., “upstream”) are internal suppliers because they provide the records and physical product that is used in the process being audited. Process owners managing the subsequent process step (i.e., “downstream”) are internal customers because they receive records and physical product from the process being audited. Internal “Suppliers” and “Customers” have a stronger connection to the process than other departments, because they are directly connected to the process. Adjacent processes are intimately involved in creating process inputs or using the process outputs for the next adjacent step in the process. If you are interested in learning more about Adjacent Link Auditing Theory, please click here to read an article in OrthoWorld’s BoneZone magazine.
If you are interested in downloading an example of a complaint handling procedure, please click here. For learning more about the process approach to auditing, you can purchase a webinar on the topic (Recording May 2, 2014. Please email firstname.lastname@example.org to order. Cost is $129).