Rework in the eyes of the ISO 13485 Standard is considered the performing of an action on a nonconforming product or service needed to eliminate a detected nonconformity and to make the Medical device conform to the requirements.
Planning rework activities
Rework is an initiated action performed on a nonconforming product or service with the intention of making it conform to the requirements. Rework is applied to a nonconforming product, and its objective is to bring the product into its full conformity in terms of intended use, performance, safety, and compliance with regulatory requirements. Rework is usually a process of the following stages:
- Accepting the need and inputs for rework
- Planning and documenting the rework activities
- Reviewing and approving the rework activities
- Documenting the relevant training on the procedure
- Performing the rework
- Validating the result of rework and reinspection.
Taking into account potential adverse effects
Adverse effects that may arise as a result of rework activities will be identified and reviewed, and their levels of risk will be evaluated. Determination of adverse effects on reworked products must be done in a risk management manner: analyze the risks of the rework according to your existing risk management process. It is very important to conduct this risk analysis before starting the rework. When a compromise is made in the performance and safety of the medical device due to rework, it must be justified and submitted to the process of concession.Before submitting the devices to rework, it is necessary to evaluate some critical issues. I specify them in Section 8.3.4 of the book ISO 13485:2016 – A Complete Guide to Quality Management in the Medical Device Industry.
Verifying the reworked product
After the completion of rework, the reworked product must be verified to ensure that it meets applicable acceptance criteria and regulatory requirements.
Performing rework in accordance with documented procedures
Each rework activity or operation must be documented. We may assume that each nonconformity will have its own specific rework instruction based on its nature and root cause. To document the rework effectively, it is necessary to identify all types of documentation needed for the rework: work instructions, diagrams, process charts, drawings, forms, and checklists.
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