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ROI CalculatorA Justification Report refers to a document that provides explanations and proofs to touch upon quality decisions, scope of the system, any exclusions made, or the treatment of risks. It elaborates the clear evidence behind the operational exceptions or the course of action taken to comply with requirements of standards such as ISO 9001 or ISO 13485.
A justification report is a formal document that explains why a specific decision, request, or investment should be approved. Sometimes even a good idea does not suffice. At times, you must present evidence. In a justification report, you will describe the situation, what you are presenting, and what the organization can gain from their investment, thus providing the decision makers with sufficient details for analyzing the case.
Here are the core components of a justification report:
The Problem or Need: The operational gap, regulatory requirement, or QMS challenge being addressed must be clearly described.
Evaluation of Alternatives: Presenting a brief overview of the other potential strategies taken into consideration and the reasons for discounting them to follow the one proposed.
Risk and Benefit Analysis: The fact that the selected alternative will ensure product safety, quality and compliance must be substantiated.
Actionable Recommendation: A detailed outline of the steps or practical changes necessary.
Given below are the key purposes of a justification report in a QMS:
Scope Exclusions: Describing the grounds upon which some provisions of a standard (e.g. design and development) are irrelevant to the organization without violating compliance.
Risk Rationale: Describing the reasons why an organization opted for a particular risk-oriented approach or a less intensive level of data governance for its minor processes.
Process Deviations: Proposing and justifying modifications, provisional solutions, or everlasting remedies to the standard operating procedures (SOP).
