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Quality risk assessment template

Quality risk assessment template

Get a step-by-step, repeatable format for identifying, evaluating, and documenting quality-related risks across your operations and teams.

Use this template
or download pdf
Quality risk assessment template

Get a step-by-step, repeatable format for identifying, evaluating, and documenting quality-related risks across your operations and teams.

Use this template
or download pdf

About the Quality risk assessment template

Quality management teams use risk assessments to proactively evaluate potential issues in their processes. This quality risk assessment template helps you standardize how to identify, analyze, and mitigate risks across your organization. After all, risks show up in all areas, from process deviations to equipment failures. The template supports a structured, proactive approach to quality management, helping you spot gaps early.

Why you should use a quality risk assessment template

A quality risk assessment template allows you to shift from reactive fixes to proactive control. Instead of starting over completely each time, you follow a clear framework for spotting hazards, assessing their impact, and deciding how to act, all in one place. That means less guesswork, more consistency, and fewer gaps slipping through.

You can use this template to align your team on risk levels, assign responsibilities, and track actions through to resolution. This saves you time during audits and gives you a documented trail of how risks were handled.

This template also reduces variation across departments or locations. You get reliable data, better reporting, and more confidence in the decisions you’re making, especially when compliance is on the line.

Key elements of a quality risk assessment template

The template supports you in capturing the right information in the right order. Here’s what that looks like:

  • General information: This sets the context. You’ll log details like the product name, code, and responsible person. Having this up front helps anchor the assessment and link it back to the specific process or item you’re evaluating.
  • Hazard identification: You use this section to describe the potential risk and its likely cause. This is where the risk begins to take shape and where clarity really matters, since vague hazards lead to vague controls.
  • Risk evaluation: This is where things get analytical. You’ll assess severity, likelihood, and how easy it is to detect the risk. This triage approach helps you prioritize what needs attention first.
  • Action and controls: You add your proposed fixes, assign responsibilities, and track deadlines. Whether it’s a training session or a process tweak, this section allows you to turn insights into action.
  • Effectiveness and conclusion: After you’ve implemented the actions, you review if they actually worked. This step gives you a feedback loop and contributes to refining future risk assessments.

Make your review process more reliable

An organized approach improves how you work and reduces time spent significantly. With Lumiform’s template, you can assign tasks, track follow-ups, and create a reliable workflow for assessing and responding to risks. It brings consistency to your documentation, no matter the size or complexity of the process. Download it today to create a repeatable, professional process that stands up to audits and inspections.

Related categories

  • Quality management templates
  • Risk management and compliance templates
  • General templates
  • Health care templates
  • Manufacturing templates
  • Quality assurance templates
  • Risk assessment templates
Preview of the template
entity_item!!!
Page 1
General Information
Product Name
Product Code
Manufacturer
Responsible Person
Risk Assessment
Potential Hazard
Potential Cause
Severity
Probability of Occurrence
Detectability
Risk Level
Recommended Actions
Actions and Controls
Action Item
Responsible Person
Target Completion Date
Control Measure Implemented
Effectiveness of Control
Conclusion
Overall Risk Level
Justification

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Related resources

Access a complete set of resources aimed at maximizing safety, quality, and operational excellence, including detailed guides, related templates, and real-world use cases.

Topic guides

Read in-depth guides covering key topics related to this article.

A beginner‘s guide to software quality assuranceCheck sheets: A guide for effective quality controlMethod statement: Your guide to compliance and quality control
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Template collections

See comprehensive collections of best practice templates related to this topic.

3 free quality risk assessment templates for professionals13 free quality audit checklists4 free product evaluation templates to assess quality
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Use cases

Check out how the Lumiform software can be utilized for related use cases.

Quality audit softwareQuality control softwareQuality risk management softwareQuality Management System (QMS) App
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Other resources

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Quality assurance vs. quality controlQuality management processWhat is quality management?4 strategies for developing a quality management plan

Frequently asked questions

What is the difference between a quality risk assessment and a general risk assessment?

A quality risk assessment focuses specifically on risks that could affect product quality, compliance, or customer satisfaction. It’s used in regulated industries like pharmaceuticals, food, or manufacturing, where even minor issues can lead to recalls or legal consequences. General risk assessments often include safety, financial, or environmental risks, not just quality-related ones.

When should you carry out a quality risk assessment?

You don’t need to wait for a problem to appear. A good time to run a quality risk assessment is before introducing a new process, changing suppliers, or modifying equipment. You can also use it during audits, after deviations, or when customer complaints suggest recurring issues.

How do you know if your assessment was effective?

You’ll know it worked if the assessment leads to action. If the you’re tracking the risks identified, responsibilities are clear, and controls are preventing repeat issues, then you’ve done it right. It also helps to revisit older assessments to see if the same risks keep showing up. If so, your controls may need adjusting.


This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.
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