When Do I Call It Rework?


By Melissa Glass

When do I call it a rework? Several variables distinguish a rework from a repair or nonconformance. This can mean many things as applied to business, lean Six Sigma operations, pharmaceutical or medical device manufacturing.

Is it a nonconformance?

Nonconformance occurs when a device does not meet a specific requirement. In medical device manufacturing, nonconformance is an umbrella that captures deviations from quality standards, regulatory requirements, procedural errors, equipment failures, or material defects. Nonconformance programs must address the root cause of systemic issues or failures and take corrective actions to prevent a reoccurrence of nonconformity.

Is it a repair?

Repairs address out-of-specification products after releasing a device for distribution to the customer. A repair takes place at the point of use, or withdrawn for repair service and returned to the customer. The repair process addresses non-conforming parts and replaces them with conforming parts of the same PN. Medical device recalls may involve repairs with new part numbers to meet new requirements or specifications.

“Rework means action taken on a nonconforming product so that it will fulfill the specified DMR [Device Manufacturing Record] requirements before it is released for distribution.”

21 CFR 820.3 (x)

Is it rework?

Rework takes specific corrective action to address any nonconformance found within manufacturing. Devices out of specifications at any point of the manufacturing process can undergo rework to salvage nonconforming products.

“Rework means action taken on a nonconforming product so that it will fulfill the specified DMR [Device Manufacturing Record] requirements before it is released for distribution.” 21 CFR 820.3 (x)

Additional costs may arise to take corrective action, to ensure the product meets specifications after the rework, and to document actions and rationale in the DHR. Trending activities can aid in understanding where a rework occurs in the manufacturing process and can prevent future issues by addressing the root cause of the nonconformance. A rework can also help an organization’s bottom line. This process allows expensive and conforming materials to be salvaged and used for the final product.

For example, consider a device with ten parts in its Bill of Materials (BOM). The device is out of specification 60% of the way through manufacturing (6 of 10 parts built or assembled) and only one part is nonconforming. Rework of the product will replace or repair the nonconforming part. This process reduces material scrap, salvages the five remaining parts, and allows a complete product within specification to go out to the customer.

Key Components of Rework

The key components of rework required by ISO 13485 and 21 CFR 820.90 include:

  1. Consideration and appropriate action for potential adverse effects of rework on the product.
  2. Rework products must be verified to ensure all applicable acceptance criteria and regulatory requirements are met. Retesting and re-evaluation of the product after the completion of rework is required to ensure current approved specifications are met, reviewed, and approved.
  3. Records or rework shall be maintained within the Device History Record (DHR). Records should include the nonconformity, actions taken for rework and reevaluation, determination of potential adverse effects from rework, any investigation into the nonconformity, and rationale for the decision to rework and release the product.

In many businesses “rework” can carry a negative connotation. However, implementing this process in medical device manufacturing benefits businesses. It ensures the end product is within specifications and with minimal waste.