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How can you integrate risk management into APQP?

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Advanced Product Quality Planning (APQP) is a structured framework for developing new products and processes that meet customer requirements and expectations. It involves five phases: plan and define, product design and development, process design and development, product and process validation, and feedback, assessment, and corrective action. However, APQP is not complete without integrating risk management, which is the process of identifying, assessing, and mitigating potential hazards and uncertainties that may affect the product quality, performance, or safety. In this article, you will learn how to integrate risk management into APQP using some practical tools and techniques.

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Suryakant Bhavikatty

Next-Gen eQMS Expert | LinkedIn Top Quality Management Voice | 5 million+ Impressions | Driving Automated End-to-end…
Ronanki Ravi

Audit Management , Quality Assurance Professional.
Suhas Deshpande

?? Elevate Efficiency, ?? Enhance Effectiveness & ?? Drive Cost Optimization with our proven methods and solutions!…

1 FMEA and FTA

One of the most widely used tools for risk management in APQP is Failure Mode and Effects Analysis (FMEA), which is a systematic method for identifying and prioritizing potential failure modes, their causes, and their effects on the product or process. FMEA helps to evaluate the severity, occurrence, and detection of each failure mode, and to assign a risk priority number (RPN) that indicates the urgency of corrective actions. FMEA can be applied at different stages of APQP, such as design FMEA (DFMEA) for product design and development, and process FMEA (PFMEA) for process design and development. Another useful tool for risk management in APQP is Fault Tree Analysis (FTA), which is a graphical technique for tracing the root causes of a specific failure event, and estimating the probability of occurrence. FTA can complement FMEA by providing a visual representation of the failure logic and the interactions between failure modes.

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Suhas Deshpande

?? Elevate Efficiency, ?? Enhance Effectiveness & ?? Drive Cost Optimization with our proven methods and solutions! #FutureOfWork#BusinessExcellence
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I have extensively used A/D/P FMEA and FTA during the three major phases of new product development for medium to high complexity systems. I have first hand experienced the solid benefits of these two risk management tools and seen multi fold improvements in product performance. The important part is that to genuinely analyze the risks using these tools and then mitigate the risks genuinely, not just as a paper exercise. You will have to use other tools like design margin analysis, useful life analysis etc. and not consider them as a complete solution for risk management. Also, it’s important to keep these updated over the life of the product as it’s not an only one time activity.

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Ganesh Shastri

Director - Stocklite Gemms Pvt Ltd
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The APQP process should go through risk management ( identification of risks, evaluating their probability of occurrence, severity / impact and mitigation) to make the APQP effective.

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2 Risk Matrix and RACI Matrix

Another tool for risk management in APQP is the risk matrix, which is a simple way of classifying and prioritizing risks based on their likelihood and impact. The risk matrix can help to determine the appropriate risk response strategies, such as avoid, reduce, transfer, or accept. The risk matrix can also help to communicate the risk level and status to the stakeholders and the project team. A related tool for risk management in APQP is the RACI matrix, which is a table that defines the roles and responsibilities of the project team members for each task or activity. RACI stands for Responsible, Accountable, Consulted, and Informed, and it helps to clarify who is in charge of what, who needs to be consulted or informed, and who has the authority to make decisions or approve actions. The RACI matrix can help to avoid confusion, duplication, or omission of tasks, and to ensure accountability and ownership of risks and actions.

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Ganesh Shastri

Director - Stocklite Gemms Pvt Ltd
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Well said - these are some of the tools - risk matrix / risk evaluation and mitigation, along with RACI that can make APQP effective. RACI ensured effective communication and participation from the relevant personnel.

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3 Risk Register and Risk Dashboard

A final tool for risk management in APQP is the risk register, which is a document that records and tracks all the identified risks, their characteristics, their status, and their actions. The risk register can help to monitor and control the risks throughout the APQP phases, and to update the information as the project progresses. The risk register can also help to document the lessons learned and the best practices for future projects. A related tool for risk management in APQP is the risk dashboard, which is a visual tool that summarizes and displays the key risk indicators, such as the number, type, and distribution of risks, the RPN, the risk response strategies, and the risk trends. The risk dashboard can help to provide a quick and easy overview of the risk situation and performance, and to support decision making and reporting.

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4 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?

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Suryakant Bhavikatty

Next-Gen eQMS Expert | LinkedIn Top Quality Management Voice | 5 million+ Impressions | Driving Automated End-to-end QMS, EHS, and Integrated Solutions
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APQP is one of the critical processes to launch your products on-time and defects free. This process covers all the types of risks to ensure quality of the projects. Few of the risks categories as a part of the APQP process are: Business risks - Technology commercial feasibility and risk assessments For making a robust product design - DFMEA Processes level agreement between CFT - Team feasibility commitment For making a robust process design - PFMEA APQP process with QMS - Risk assessments to capture process level risks. These are the few risks which ensures the quality of the projects and launch products on-time.

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Ronanki Ravi

Audit Management , Quality Assurance Professional.
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Involve all stakeholders:? Risk management should be a cross-functional effort, involving stakeholders from engineering, design, manufacturing, and quality assurance. Use data-driven decision making:? Use historical data, industry benchmarks, and expert judgment to assess the likelihood and impact of potential risks. Be proactive:? Don't wait for problems to occur before taking action. Develop contingency plans and risk mitigation strategies early on. Update the risk register regularly:?As the product and process design evolves, the risk register should be updated to reflect new or changed risks.

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Atul Shukla

Lead - Quality Assurance Group at Path Infotech
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APQP and Risk Management Identify any product and process risk. Develop contingency plans. Review designs for manufacturing practicality. Create and prepare suppliers for requirements and milestones. Validate a product and a process that satisfies customer requirements. Monitor on-going production to ensure process stability.

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Akshay Ramanath Hegde

Lead auditor |New Product Development & Quality Assurance | Supplier Development Expert |IRCA Approved Lead Auditor | ISO 9001 | 14001 | 45001 | IATF 16949 | VDA6.3 | LSSGB Certified
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Risk management is an integral part of Advanced Product Quality Planning (APQP). It helps to identify, assess, and mitigate potential hazards & uncertainties that may affect product quality, performance, or safety. 1. Develop a risk management plan that outlines the process for identifying, assessing, and mitigating risks. 2. Identify the key product and process requirements, as well as the associated risks. 3. Conduct FMEA to identify, assess, and prioritize potential product & process failure modes. 4. Conduct risk reviews on key decisions and changes. 5. Conduct validation activities to verify that the product and process meet all requirements. 6. Develop contingency plans for identified risks.

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How can you integrate risk management into APQP?

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4

1 FMEA and FTA

2 Risk Matrix and RACI Matrix

3 Risk Register and Risk Dashboard

4 Here’s what else to consider

Product Engineering

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How can you integrate risk management into APQP?

1

2

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4

1 FMEA and FTA

2 Risk Matrix and RACI Matrix

3 Risk Register and Risk Dashboard

4 Here’s what else to consider

Product Engineering

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