How do you document the design qualification results and deviations in a clear and concise way?

1 DQ protocol and report

The first step in properly documenting the results and deviations of a Design Qualification (DQ) is to create a DQ protocol and report. These documents should follow a standard format and include an introduction that provides the background, purpose, and scope of the DQ, references that list relevant standards, guidelines, and documents used for the DQ, design specifications that describe the design features, functions, and performance of the system or device, acceptance criteria that define the minimum requirements and specifications that the system or device must meet, test methods that describe the procedures, tools, and data sources for verifying the design specifications, results that present data, observations, and analysis of the test methods, deviations that identify and explain any deviations from the acceptance criteria or the design specifications, conclusions that state whether the system or device meets the DQ objectives and requirements, and recommendations that suggest any corrective actions, improvements, or modifications needed for the system or device.

2 DQ examples and templates

The second step in documenting the DQ results and deviations is to use examples and templates that can help you organize and present the information in a clear and concise way. Examples and templates provide a consistent structure, format, and style for DQ documents, as well as help to avoid common errors. You can find various examples and templates of DQ protocols and reports online, or create your own based on specific needs. When using or creating DQ examples and templates, key elements to consider include a title page with name, date, version, and approval of the DQ document; a table of contents listing main sections and sub-sections; an executive summary providing a brief overview; and appendices containing additional or supporting information such as drawings, diagrams, calculations, or data tables.

3 DQ results and deviations format

The third step in documenting the DQ results and deviations is to format them in a way that is easy to read and understand. The format should be consistent with the DQ protocol and report, and should include clear and concise language without jargon or acronyms. It should also include tables, charts, or graphs to present data, observations, or analysis. Additionally, numbering, bullet points, or headings should be used to organize the information in a logical and sequential way. Finally, color coding, symbols, or labels can be used to indicate the status, category, or priority of the results and deviations.

4 DQ results and deviations review

The fourth step in documenting the DQ results and deviations is to review them for accuracy, completeness, and compliance. During this review, multiple stakeholders such as the design team, the quality team, the user team, and the regulatory team should be involved. Additionally, a standard procedure should be followed which includes checking that the results and deviations are correct, consistent, and complete; comparing them with the acceptance criteria and design specifications; confirming that they meet DQ objectives and requirements; and commenting on any issues, concerns, or suggestions related to the results and deviations. This feedback or recommendations should be provided to ensure compliance with applicable standards and regulations.

5 DQ results and deviations approval

The fifth step in documenting the DQ results and deviations is to obtain approval from the authorized personnel. This formal and documented process confirms that the system or device is ready for the next phase of equipment qualification. The approval should include a signature with name, title, role, and date of the person who approves the results and deviations, a statement with rationale, justification, or condition for approving the results and deviations, as well as an action to be taken after approving the results and deviations such as proceeding to installation qualification (IQ), implementing corrective actions, or closing deviations.

6 DQ results and deviations management

The sixth step in documenting the DQ results and deviations is to manage them throughout the equipment qualification lifecycle. This management process is ongoing and dynamic, ensuring that the system or device remains in a qualified state. It should include the following activities: recording and storing results and deviations in a secure location, communicating them to relevant stakeholders, resolving any deviations from acceptance criteria or design specifications, and revalidating the system or device if there are any changes or modifications that may affect its performance or functionality. All processes and outcomes must be documented.

7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?