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Hi everyone,
A small medical device company (company A) is currently transitioning the production process in house from a contract manufacturer (CMO) who up until spring 2017 was assembling the finished device for company A. Here is the issue. Company A's products are known as "built-to-order" (they manufacture the product only when there is a new order from a customer). Since transitioning from the CMO, there has not been an order. We do not have a set of DHRs in time for an ISO surveillance audit. Would it matter if we have not assembled the DHRs yet however the manufacturing facility (Company A) just has the SOPs in place? The auditor will not have the DHR records to look at (as in product assembled in house). How would this affect this audit?
Thank you.
A small medical device company (company A) is currently transitioning the production process in house from a contract manufacturer (CMO) who up until spring 2017 was assembling the finished device for company A. Here is the issue. Company A's products are known as "built-to-order" (they manufacture the product only when there is a new order from a customer). Since transitioning from the CMO, there has not been an order. We do not have a set of DHRs in time for an ISO surveillance audit. Would it matter if we have not assembled the DHRs yet however the manufacturing facility (Company A) just has the SOPs in place? The auditor will not have the DHR records to look at (as in product assembled in house). How would this affect this audit?
Thank you.