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Quality by Design: Incoming Acceptance Activities of Purchased Materials

All manufacturers of orthopaedic medical devices must establish and maintain procedures to verify that all products meet their specifications and acceptance criteria. Acceptance activities can include, but are not limited to, inspection and testing, the use of certificates of analysis, supplier audits, ship-to-stock agreements, workmanship criteria, etc. The orthopaedic company must define the activities for receiving, in-process and final acceptance of all parts, components and materials that will become part of the finished device or part of the manufacturing process. This article is focused on the first stage of this overall acceptance process…receiving acceptance.

Incoming acceptance activities must include procedures for acceptance of received product from qualified and monitored suppliers. Companies do not need to inspect each lot, batch or item. However, the company must have a defined method of evaluating whether that lot, batch or item meets the established specifications. The decision of whether to accept or reject the product must be documented using approved acceptance criteria developed during the design process.

There are inherent linkages between acceptance activities and purchasing, manufacturing and the final release of finished devices to the field. These links produce objective evidence that enables the authorization and subsequent movement of products throughout the quality management system and then to the customer and/or the first consignee. These verification activities are paramount to the eventual use of credible product(s) to make safe and effective orthopaedic medical devices.

Quality Assurance Notes

  • The definition of the word “product” means components, manufacturing materials, in-process devices, finished devices and returned devices.
  • FDA adopted the ISO 8402:1994 definition of verification. This definition is also consistent with the definition in ISO 9000:2005. Verification ensures that outputs for a particular device or activity meet the specified input requirements. Examples of verification are software module testing, component material testing, assembly material testing and raw material analysis.
  • All materials are subject to component controls. Those controls include the requirements as specified in the Acceptance Activities Process of the QS Regulation.
  • Process validation ensures that the process consistently produces conforming results and products when it is controlled appropriately. Validation of a process depends upon components that are in specification and received from a qualified supplier.

Verification Methodologies are Established During Design Controls

Verification of physical components and raw materials is a very important step toward producing a high quality product. Verification of these incoming materials consists of determining through documented testing that a component will perform its function reliably in the intended application and under the most adverse environmental conditions in which the device is expected to be used. These conditions shall consider the needs of the user and patient, and shall encompass the manufacturer's labeling claims for the device as delineated during the design control process.

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