S
spiderman
We are a laboratory testing service organization that is both FDA registered and ISO13485 certified. We host between 40 and 50 customer audits per year. The audits are typically one day audits covering our QS and specific records for the service we perform for ach particular client. Although management has a strong commitment to getting them done, we have struggled with trying to complete our internal audits for a variety of reasons: lack of resources, lack of interest of personnel to be auditors, etc.
We have come up with an idea and would like some feedback on whether this approach meets the intent of the FDA regs and ISO standard.
For each customer audit we maintain detailed records of the audit:
-audit agenda,
-elements of the standard audited,
-list of documents reviewed by the auditor,
-any OFI's, observations, NC's, reports,
-any CAPA's or actions taken to address findings.
We would like to leverage the outputs from those audits to come up with an internal audit plan that may or may not include certain elements of the standard based on the number of times a particular element has been audited in a customer audit and what the outcomes were. If the data shows a robust system with no findings or OFI's we would justify not including it in our internal audit plan as there would likely be minimal value added. If there have been observations, NC's or OFI's, then we would include that element in order to dig deeper into the system to target improvement opportunities and to verify that any previous CAPA has been truly effective.
Thanks!!
We have come up with an idea and would like some feedback on whether this approach meets the intent of the FDA regs and ISO standard.
For each customer audit we maintain detailed records of the audit:
-audit agenda,
-elements of the standard audited,
-list of documents reviewed by the auditor,
-any OFI's, observations, NC's, reports,
-any CAPA's or actions taken to address findings.
We would like to leverage the outputs from those audits to come up with an internal audit plan that may or may not include certain elements of the standard based on the number of times a particular element has been audited in a customer audit and what the outcomes were. If the data shows a robust system with no findings or OFI's we would justify not including it in our internal audit plan as there would likely be minimal value added. If there have been observations, NC's or OFI's, then we would include that element in order to dig deeper into the system to target improvement opportunities and to verify that any previous CAPA has been truly effective.
Thanks!!