Information & Training. | Product & Process Validation.The design validation process consists of a number of stages. User needs are identified and documented. These then become the input into the design process. The design evolves during the development process, until an output is ready for review. The design output may need to undergo a number of iterations, until the final product is ready for release.
At various pre-determined stages, design reviews will need to be performed. The attendees at these reviews will normally be pre-determined, with certain minimum attendee requirements, for example, engineering, quality, research and development, marketing, customer representatives, clinical reviewers (for medical products), etc..
The design review is a comprehensive, documented, systematic assessment of the adequacy of the design output, at the design review stage to the design input (customer) requirements. The review examines the ability of the design to meet the input requirements.
Design Verification and Design Validation.As the product or process progresses through the design stages, the need for verification and validation will be determined. The designers will initially assess verification and validation needs in accordance with the pre-defined quality system requirements. Their assessments and the results of the on-going verifications and validations will be considered at the on-going “design reviews”, where the team of reviewers will accept the level of verification and validation proposed, or will suggest amendments.
Throughout the design process a full documentation trail will be maintained. This will build into a detailed design history file.
In addition, as the design progresses, a risk assessment and risk management process should be implemented. This will identify the risks to the various stakeholders of the design process (e.g. end customers, business financial risk, employee safety, regulatory compliance risks, etc.). The risk management process will also point to where the validation efforts need to be focused. Clearly the areas of higher risk will require more comprehensive verification and or validation.
The output from the design process will be the required product or process. Additionally the output may include bills of materials, assembly schematics, component specifications, software codes, servicing procedures, work instructions, packaging, labeling, etc.
Verification and validation activities will need to assess the suitability of all outputs to the input requirements.
Design Validation.The approach to validating the new design or design revision needs to be clearly defined, documented and approved in advance of commencing a design activity. Validation should be performed on sample lots, prior to actual production runs.
The design validation should confirm that the product or process conforms to customer requirements.
The validation should include testing under expected operating conditions plus testing to the allowed limits of use.
Validation should cover all design outputs, based on potential risk. For example, if incorrect labels could post a risk to consumers, then the label manufacture and control process should be validated. If a risk assessment deems that verification would be an in-adequate control or if verification is not to be performed due to cost considerations, then validation needs to be performed.
The results obtained from all validation activity, should be documented, and maintained in the design history file. The file does not need to physically contain all documentation, but should point to where such documentation can be obtained.
It is important to ensure that a comprehensive records storage, archiving and maintenance process is established to ensure that validation results can be readily retrieved even when performed years previous.
Information & Training.
Product and Process Validation.
- The Validation Master Plan. Performing a Gap Analysis. Validation in the Design Process. Etc..
- How to ensure Validation efforts are aligned with potential Risks.
- How to ensure that Validation activity is appropriately documented, reviewed and aligned with requirements.
- Information & Training presentation >>>