Bringing Partnership to a Quality Management System

GUIDE TO OUTSOURCING

The ability to implement a seamless and sound quality management system (QMS) for a medical device OEM is one of the characteristics of a solid, experienced outsourcing partner. It takes a deep level of knowledge and experience to integrate a QMS into a contract manufacturing process. It also requires an understanding of the OEM's needs, roles, and responsibilities. Implementing a sound QMS is critical in medical device manufacturing. And, as such, it should be established at the beginning of an outsourcing partnership.

The QMS responsibilities of both an OEM and outsourcing partner must be clearly defined, understood, and managed. Having an organized process ensures regulatory compliance and helps determine which party is responsible for which activity. Too often, developing the quality system relationship is a secondary focus to the manufacturing supply agreement. Making the QMS a priority can ensure a successful partnership.

Implementing a Quality Plan

A successful QMS implementation and partnership begins with clear expectations of responsibilities. A quality plan for manufacturing a product is critical to a successful outsourcing relationship.

Some companies approach this task by creating an agreement standard operating procedure (SOP). The agreement SOP outlines the expectations and responsibilities of both the outsourcer and the OEM. Employing such a plan is not only good business sense, but it also satisfies requirements in both 21 CFR 820.20 and ISO 13485:2003.

The most efficient and productive way to create such a document is by engaging in joint discussions with the quality, manufacturing, and engineering leaders from each company early in the process. The agreement SOP should be succinct and clear, using language and explanations that team members can understand and reference easily. The document may also serve as a training source for new personnel. A matrix grid that is based on the ISO 9001:1996 format (see Table I), can help companies itemize the most important responsibilities.

Custom Fitting the QMS

It is important to keep in mind that different project managers may have different ideas about their responsibilities and expectations. An agreement SOP should strive to merge these expectations for a consistent understanding and framework. That means that every agreement SOP requires some tailoring. Both OEMs and outsourcers should have some flexibility and should provide options to meet each other's specific needs.

There are several areas in which an OEM may choose the degree of control it needs for project management. These areas depend greatly on core competencies already in place and the experience levels of an OEM and its outsource partner.

Quality System. An OEM may want to ensure quality system effectiveness by conducting periodic on-site audits, by performing annual ISO 13485:2003 recertification, or through implementing a metrics-based reporting system. The choice of methods is driven by a combination of the OEM's capabilities and its familiarity with the outsource partner. In all cases, the contract firm must maintain FDA registration and ISO 13485 certification.

Design Control. For new products, an OEM may choose a design control process in which the OEM manages both device and process development. Alternatively, an OEM could choose to have the outsource partner develop the manufacturing process. In that case, the OEM should have approval of product validation results.

Document Control. OEMs may want to control and manage component and product specifications within their own documentation system. If so, they will need to provide release specifications and revised product specifications to the contract manufacturer. Alternatively, the contract manufacturer should have the ability to incorporate these specifications into its documentation system and the OEM may prefer it that way. The OEM generally must approve all changes.

Purchasing. The contract manufacturer is usually responsible for purchasing generic supplies, performing component and materials testing, and maintaining supplier performance management. However, the OEM may want to control suppliers by taking responsibility for supplier selection and maintaining approved supplier lists. This is especially true if the supplied component is proprietary. Alternatively, the companies can maintain joint supplier selection and performance management responsibility.

Product Identification and Traceability. The OEM may want control of component and product lot traceability maintained within its own system. Generally, however, it should designate this responsibility entirely to the outsource partner and its traceability control system.

Process Control. In typical agreements, the OEM takes responsibility for reviewing and approving product manufacturing process validations for new products. It also reviews and approves qualifications or validations for changes affecting the form, fit, or function of the device. OEMs typically need to maintain process control responsibility. They need to ensure that device design characteristics are maintained. However, in many cases the contract manufacturer can take control of qualifying or validating the manufacturing process and implementing controls to meet specifications. In cases where the outsource partner has a proprietary manufacturing process, it is required to manage process control.

Inspection and Testing. An OEM can opt to have the outsource partner perform inspection and testing for components and subassemblies as they come in and as they move through the process, as well as testing packaging and finished products. Alternatively, OEMs may want the responsibility of controlling inspection and testing. These functions can be controlled via lot acceptance testing that the OEM performs independently of the outsource firm. This may be especially important at the beginning of a partnership.

Inspection, Measuring, and Test Equipment. The agreement SOP should also include a provision for calibration and maintenance of test equipment. OEMs may choose simply to provide test equipment as well as specific use or method requirements. They should give instructions about calibration or preventive maintenance for any unique fixtures. This is especially true if omitting such specifics could adversely affect product quality. It is the contract manufacturer's responsibility to integrate, control, and calibrate the equipment.

Control of Nonconforming Products. Typically, an OEM reviews and approves nonconforming products as they relate to form, fit, or function. The contract manufacturer often handles all the rework and test requirements for any product that does not meet specifications.

Corrective and Preventive Action (CAPA). OEMs may feel more comfortable being responsible for product tracking and other corrective actions in their own systems. However, contract manufacturers should have these systems in place as well, so it may be suitable to implement dual corrective action tracking systems.

Complaint Handling. Complaint handling is often linked to CAPA. Therefore, whatever agreement is reached for CAPA should extend to complaint handling. An OEM can choose to control receipt of complaints, investigation, customer responses, and archiving records. Or it may ask the contract manufacturer to manage complaint receipts, investigations, and archive records in its own system with the OEM solely responsible for any response to customers. A dual system may be preferred if the OEM performs initial complaint receipt and investigation and, if deemed appropriate, an additional investigation is performed by the outsource firm.

Handling, Storage, Packaging, and Delivery. There are a few options for handling delivery. OEMs may want to ship components from their own inventory for product build and then have the outsource firm ship finished packaged products directly to a sterilization facility. Or, the contract manufacturer can order and inventory the components and ship finished packaged products to the OEM. Depending on the product, the outsource partner may also be called on to ship finished products directly to the customer.

Quality Records. OEMs may choose to have the outsource firm maintain device history records (including quality control records) for the life of the product. These documents help demonstrate achievement of the required product specifications and quality elements. Alternatively, records may be sent to the OEM for product release decisions, or after a designated period of time for records management.

Statistical Techniques. Typically, the OEM will take control of statistical techniques for the design phase. Once that phase is complete, the OEM should identify the statistical methods to be used for qualification, validation, and product acceptance by the outsource partner.

OEM Property. OEMs may take responsibility for specifying maintenance and calibration processes for fixtures, test equipment, or software that they have provided, while outsourcer partners take charge of ongoing maintenance of fixtures and perform calibration procedures.

Product and Sterilization Release. The OEM may want to maintain all product release and sterilized product release responsibility. This decision should be based on product testing results received from the contract manufacturer and the sterilization and microbiology testing providers. Alternatively, the OEM can specify requirements surrounding product testing, sterilization, and microbiology and, if met, authorize the outsource firm to release product.

Accepting Responsibility

There are numerous ways to share quality system responsibilities between the OEM and the contract manufacturer. The most important thing is that everyone agrees with the responsibilities, the tasks are documented, and people are properly trained.

Team meetings should be scheduled to address problems and build strong working relationships. This is critical because even the best efforts to produce a comprehensive QMS responsibility document will not account for every problem. Day-to-day issues will occur that are either outside the scope of the document or are not clearly addressed. Such issues should be addressed immediately and agreed upon in regular operating meetings. These meetings are especially valuable early in the relationship, not only to address issues together, but also to build trust between the two parties.

It is important for one team member to take minutes of these meetings with details on decisions of responsibilities and steps for future reference and documentation. Some examples of gray-area issues that may require assigning sole or joint responsibility include

CAPA and Complaints

Team effort is also required for investigations and corrective actions, which are critical elements of QMS implementation to ensure that end-user or OEM feedback has a rigorous response.

It is often difficult to document or even determine the responsibility for an investigation, and there are many possible corrective action measures and root-cause possibilities. For example, an end-user complaint may be tracked to product design, supplied parts, the manufacturing or distribution processes, or customer use. As a result, end-user feedback and complaint investigation and corrective systems require, in most cases, a joint responsibility between the OEM and the outsource partner.

It should be noted that turning over responsibilities for CAPA and complaint handling to an outsource firm carries significant regulatory implications. If FDA inspects the OEM's quality system, the agency will almost certainly want to look at complaints and CAPA. If the outsource firm holds those records, it is imperative that the OEM has complete trust in its system. The OEM must be confident in the contract manufacturer's ability to properly represent the OEM to a regulatory body.

A standard investigative process should be documented jointly between the OEM and the contract manufacturer. Routinely scheduled meetings offer the opportunity to review customer feedback and complaints as they arise, to discuss investigation status, and to take appropriate corrective actions. All actions should be agreed upon, tracked, and documented for closure in a timely manner.

Keep in mind, however, that there is absolutely no way for an OEM to delegate regulatory responsibility for quality functions. That responsibility resides solely with the OEM. If parts of the system are assigned to a partner, it is imperative that the OEM maintains appropriate controls, metrics, and monitoring.

Conclusion

Implementing a successful QMS depends on documenting processes and responsibilities as well as effective routine communication systems to which both parties have contributed and agreed. The personnel involved with the implementation must be committed to resolving problems, concerns, and questions in an active and cooperative manner that ultimately benefits the product's end-user.

Early on, there will be a ramp-up period as the teams build communication, confidence, and trust. This is a very critical phase that must proceed smoothly to move to the next level of benefit for both parties. In the end, both parties can expect a cooperative effort towards tasks, projects, and goals to maximize profitability and to bring product quality to the end-user.

Roger Brink is senior program manager at ATEK Medical Manufacturing (Grand Rapids, MN). He can be reached at [email protected].

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