The third output of the manufacturing process is the record of the manufacturing – a series of documents that need to be created, stored and maintained for a variety of reasons.
Manufacturing Process Documentation
An important output of the manufacturing process is the record of the manufacturing.
For medical products, there is a required Device History Record (DHR) which documents all the important milestones in the product manufacture and service history for the life of the product. Depending on the level of risk, other non-medical products have DHRs which follow the product for its life. Almost all these records are maintained electronically.
Standard Documentation – this includes business documents, Bill of Lading, Invoices, Status reports, etc. It also includes Batch Records – these records identify the job numbers and personnel working on a group of products. The batch records are useful in tracing manufacturing process controls. We maintain electronic records for our QMS system which includes Document Control, Device Master Records, CAPA systems, Engineering Change Records, Product Deviation Records, etc.
Market Required Documentation – records of the manufacture and component traceability may be required by your market. This information needs to be given to the manufacturer as they begin the manufacturing process design to be sure the correct information is being recorded and maintained. Many companies, including Product Resources, use electronic records for capturing this information so we can track the product configuration, test results, and performance. We store batch records of a product build, and in most cases, we maintain individual records for each unit by part number / serial number.
- Traceability – Product Resources has systems in place to record Lot Numbers and Serial Numbers for components installed on a product. These records are key when issues are discovered later and there is a need to identify the units which have the suspect component batch installed. Traceability records are required for some product markets (e.g., medical devices), but optional for others.
- Device History Record – many products require individual records of the manufacture. If the product is ever returned for service (e.g., calibration) or repair (warranty or out-of-warranty), these records are amended to include the services performed. The DHR would typically include:
- Test Reports
- Calibration Reports
- Product Configuration Reports
- Factory Acceptance Test (FAT)
- QA Release Records
Optional Documentation – there are other records that may be required based on customer requirements. In some cases, Product Resources is using consigned material supplied by our customer and we provide periodic reconciliations on the use of that material. This class of ad hoc documentation covers all the special and unique cases that are not yet built into our systems.