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.


Components and raw materials have to be carefully selected, using the requirements of the device as a guide. Components should be chosen so that they will not be over-stressed and will be compatible with the internal device environment, as well as the external environment that the device is expected to encounter during manufacture, distribution and use. The components should then be appropriately tested, alone and as part of the device, utilizing the specifications established for the component and the device. New components or components used in an unusual application will usually need extensive evaluation. This evaluation should include parameter and life testing as well as compatibility testing for both the internal and external environment. Well-known industry standard components that are used in their normal application and that are not over-stressed will need only minor testing, which is usually an integral part of the verification of the device design. A record of any component verification testing should be maintained. This record should include the component identity and the testing methods that were used, as well as the actual test data and results.

Having Qualified Suppliers is a Fundamental Step

A major factor in obtaining high quality components and raw materials for the manufacture of orthopaedic devices is the selection of competent suppliers. Although a manufacturer's knowledge of supplier operations may be limited and information about the operations difficult to obtain, the cGMP-QS Requirement that a manufacturer is responsible for quality remains undiminished. To the maximum extent feasible, selection and qualification of these suppliers by audits, performance analysis, acceptance criteria being met, etc., should be an integral part of the quality management system. If a company does not have the capability to test components for conformance to specifications, then supplier test data or outside lab results are acceptable provided that components are tested and inspected in a statistically valid manner to show their acceptability for use in the finished device. Any outside test results should be accompanied by relevant raw data used for the test so that judgments of authenticity may be made by the finished device manufacturer. Excluding a supplier whose components are unreliable from supplying components may help prevent problems with the products.

Acceptance Procedures

Written instructions are necessary to assure that components, manufacturing materials, etc. are properly identified, processed and stored when received. Written inspection and test procedures are necessary to prescribe the acceptance activities performed, the dates when acceptance activities are performed, the results, the use of a signature of the individual(s) conducting acceptance activities for the proper authority and, where appropriate, the equipment used. A device manufacturer shall establish and maintain procedures to ensure that all purchased and otherwise received product conform to specified requirements and establish and maintain procedures for acceptance activities. The manufacturer shall assure that all lots of components or other products are accepted, sampled, tested and/or inspected using written procedures. The design verification procedures (originally coming from the design process) usually may be used to develop production test procedures. The procedure should specify items to which it applies, product characteristics to be inspected/tested, acceptance/rejection criteria, validated test method(s), data forms, sampling plans and the necessary test inspection equipment and tools.


Acceptance Criteria

Companies should have specific acceptance criteria for products. Acceptance criteria are the attributes of a product that determine its acceptability, such as appearance, dimension, purity, performance characteristics, etc. Typically, acceptance criteria are made a part of the inspection/test procedure as originally developed during design controls. For example, if product specifications or a drawing adequately describe the attributes needed in order for the product to perform in its intended manner, these may be used as the acceptance criteria.

When assuring that components and other products meet acceptance criteria, manufacturers may test either all or a portion of the components using a sampling plan based upon an acceptable statistical rationale. A manufacturer shall be prepared to demonstrate the statistical rationale for any sampling plan used. Plans should be developed by qualified mathematicians or statisticians, or be taken from established standards such as ANSI Z1.4. It should be recognized that all sampling plans have a built-in risk of accepting a bad lot.

Acceptance and Rejection Records

Adequate records shall be maintained to provide objective evidence that components were inspected and accepted or rejected. These records are a part of the device history record and should be maintained in a format that facilitates review. The records, however, are not required to be maintained in a single file with other production history records, and are typically filed in the receiving or quality control area according to part number or component nomenclature. Small manufacturers may use purchase orders or packing slips to record acceptance and rejection if they contain adequate information (e.g. acceptance or rejection documentation, number and type of deficiencies, quantity approved, quantity rejected) and the nature of the risk-based corrective actions taken as appropriate and necessary.

Although not a direct requirement, all raw materials and components used in the finished device are best served if they are received through a central control point. Centralized receiving leads to orderly storage, limits access to stored material and aids a manufacturer in meeting other GMP requirements. Components and other product should be identified or stored so that it is obvious at all times that product has been accepted, rejected or is awaiting a disposition decision. A quarantine area can be either a physically secure or simply limited access area identified as a quarantine area. If special environmental storage conditions are required, such as for many biologically derived components, these conditions should be controlled and monitored and the associated specifications included in the device master record.

Conclusion

Incoming acceptance activities include verification of the specifications with components and raw material acceptance criteria in place. It all starts during design controls. The high risk importance of this process step becomes rather evident when you associate the success of future activities such as manufacturing, packaging, sterilization and distribution to the end user. These safety and effectiveness assurances are then transferred to the production arena, where work-in-process verification activities are realized in continuance.

 

John Gagliardi has had success over the past 40 years in the Medical Device and Pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. John specializes in building systems in a compliant and business-ready manner. Email John at This email address is being protected from spambots. You need JavaScript enabled to view it..

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