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Purchasing Controls: Draft the Best Supplier Quality Agreement

The “NO CHANGE” Agreement

…..don’t change “anything” unless you have my permission first…..

As I indicated, requirements for purchased products and services must be documented to ensure that suppliers provide a product or service that conforms to specified requirements. If the requirements change or the supplier makes changes to the device or process, the customer must not only be aware of the change, but must approve the change prior to implementation. FDA still believes that this change information is essential to the core competencies of the manufacturer, and that the manufacturer should obtain information on changes to the product, process or service in a timely and documented manner. Where a supplier refuses to agree to provide such notification, depending on the product or service being purchased, it may render that company an unacceptable supplier. However, where the product is in short supply and must be purchased, the manufacturer will need to heighten control in other ways, e.g., heightened incoming inspection. FDA has given manufacturers the flexibility to define in the agreement the types of changes that would require notification. And, yes, the decisions being made are based upon risk management requirements.

Suppliers must ensure that adequate notification is provided for changes that may affect the form, fit, function, reliability, serviceability, performance, functional interchangeability, regulatory compliance, safety or interchangeability of the product, part or service. This may include changes made by sub-suppliers. This allows the manufacturer to assess whether the change may affect the overall quality, safety, performance or effectiveness of affected devices. Notification of changes must include description of the change, proposed implementation date and affected products, parts or services. Notification must be in writing and should be addressed to a purchasing representative. Some larger companies require a minimum of six months’ notice prior to implementing a change. For instance, there may be revalidation, verification or re-qualification involved, and that doesn’t happen in three days.

For documentation such as production drawings, specifications, assembly procedures, etc., FDA agrees that the requirement for changes be approved by an individual in the same function or organization that performed the original review and approval, unless specifically designated otherwise. The intent of the requirement is to ensure that those who originally approved the document have an opportunity to review any changes, because these individuals typically have the best insight on the impact of the changes. The requirement is flexible, however, because it permits with a documented rationale the manufacturer to specifically designate individuals who did not perform the original review and approval to review and approve the changes. In this way, the review and approval will not be haphazard, in any case.

What Product, Process or Service Should Have a Formal Agreement?
You should have a formal policy that defines the type of product, process or supplier type that needs a supplier quality agreement. Contract manufacturers and contract sterilizers clearly qualify, as do suppliers of critical components.

Common materials purchased in large quantities often qualify, to some extent, whereas services that don’t impact your product or process in a quality assurance manner probably won’t apply. Yes, I know! It depends on quantitative risk-based decision-making. Don’t forget, when the risk dictates, defined controls around second or further-tier suppliers may also be needed.

Control points within your quality management system (QMS) that have an effect on this risk-based decision can include:

  • Control of second or further-tier suppliers
  • Audits and timely Supplier Corrective/Preventive Actions (SCARS)
  • Testing/Verification
  • Certificates of Analysis/Conformity
  • Formal requirements for the QMS, such as specific certificates (QMS, environmental management, accredited labs, access rights for third party assessment)
  • What to measure and how (e.g., ppm, Key Performance Indicators)
  • Measurement System Analysis (e.g., Gauge R&R, Gauge Correlation Studies)
  • Activities to ensure environmental compatibility, electromagnetic compatibility, reliability/reliability forecasts
  • Process capability and Process capacity
  • Process validations
  • Response times
  • Statistical process control
  • Correction, reworking
  • Inventory control (First-In-First-Out/FIFO, time limit (time target) )
  • Batch sizes, lot sizes
  • Traceability (Process, product, equipment, operators)
  • Change Control (changes to process, parts, procedures, etc., regardless of who initiated)
  • Configuration management
  • Protection of intellectual property
  • Protection of patient information
  • Document retention periods
  • Quality system records


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