There are many differences in working in a compliant, finished medical device manufacturing facility when compared to a non medical device manufacturing organization. I have been fortunate enough in my career to have worked in both types of organizations within Coghlin Companies. Coghlin Companies has two manufacturing companies under its umbrella; one of which is a broad market based contract manufacturing (CM) environment, Columbia Tech, and the other is Coghlin’s FDA compliant medical device manufacturing company, Cogmedix. Currently working in the medical device manufacturing field as a Project Manager, I have learned the importance in the differentiating factors driven by compliance between the two types of service providers.
As a finished medical device contract manufacturer and specifically according to the Cogmedix Quality System, we take exception to design related activities. We collaborate very closely with our customers and assembly personnel and provide the experience to offer manufacturing simplicity recommendations, but in the end it is our customer, the design specifier and manufacturer of record with the FDA, who owns the complete design and documentation package. We rely on our customers to release changes to Cogmedix through a controlled ECO process. However, with any release of such product packages we will review and perform documentation validation and report our findings, as well as feeding back those suggestions for improved manufacturability to our customer. Our experience and ability to provide this service is essential to maintaining superior quality and reducing costs to our customers.
As a Project Manager at Cogmedix, a lot of the compliance work is done “behind the scenes” in preparation for production. From maintaining and developing complete Device History Record (DHR) work order routing documentation, to designating and sending the “critical components” through our incoming inspection process, it is important that we have complete traceability of the products we manufacture, most times all the way down to the component level, and the human resources that performed each task along the way. Other compliant activities that need to take place before we go into production are the creation of the Device Master Record (DMR), contract review, and NPI (New Product Introduction). During the NPI process, we capture any and all special requirements needed for production. It could be something as simple as a tool or something more complex such as environmental conditions, but it is important that all these items are outlined at this stage of the project in order to make a smooth, compliant transition to the floor. Other topics covered and documented in the NPI process that are very specific to medical device manufacturing include:
• Serialization/tracking requirements – Cogmedix maintains serial number traceability documents for all units manufactured for each individual customer.
• Routing setup for the Device History Record (DHR) – an internal word document is created for each level of assembly that captures revisions of all documents used in the assembly, checks and balances for each step of the process, and sign-offs for each operation by each operator.
• Assuring suppliers are on the Approved Vendor List (AVL) – customer required suppliers or any new suppliers that are not on the existing AVL will be added according to the appropriate internal processes and procedures.
• Life of product and retention time determination – Cogmedix maintains all product records for the length of time directed by the customer, which is no shorter than the expected life of the product and in accordance with all FDA requirements.
• Risk analysis – all processes and procedures of the product are outlined to determine potential risks and hazards from the kitting process right through to the packaging of the finished device.
• Device History Record (DHR) checklist – all documents essential to the final, finished device are outlined and verified by both the Project Manager and Quality Manager before the product leaves the facility.
• Creation of torque verification sheets – any customer defined torque requirements are captured on an internal document which travels with each unit for sign-off at the appropriate stages of the process.
• Critical component traceability – any item or component that is deemed by the customer as critical, Cogmedix will determine the best way to document the serial number of such components in the DHR package. This could be a simple photocopy of a serial label or a defined sequence in the work order routing document, but any recording is required before installation into the final product.
• Process Validation Report – in conjunction with the Director of Quality and Compliance, the process validation report is documented using a defined number of units that captures all documents required for the build as well as any discrepancies or uncertainties in those documents.
These are just some of the activities that set Cogmedix apart from a non-medically focused contract manufacturer.