Product Risk Management Services for Reliable Product Development
Risk Management in Product Design & Development
Product development has many processes and smaller steps, and each step has its own risk. There could be design constraints, for example, due to component failures, and manufacturing challenges or bottlenecks in the supply chain. Tests could also be incomplete or require additional iterations.
The product development cycle presents many opportunities to manage risk. We provide a clear, methodical approach to assess and mitigate risks through engineering analyses, design, prototyping, and manufacturing. We provide these services to product teams at different stages of the product development cycle to aid decision-making before risks adversely affect the product's cost, time, and quality.
We develop products our customers can depend on. We work to eliminate unknowns and take the uncertainty out of the New Product Development Process. We take our customers from development to production with confidence.
Understanding the Risks Involved in Product Design and Development
The development of any product involves more than creating a design. As a product progresses from concept to architecture, to detailed engineering, and from there to prototyping, verification, design transfer, and production, there are many risks that may arise during the process.
Examples of product development risks may include:
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Design and Engineering Risks: Issues with requirements, design, component selection, tolerances, system integration, and performance may affect the product's function and the product's reliability.
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Component and Supply Chain Risks: Issues may arise as a result of long-lead components, supply chain dependencies, part obsolescence, limited sourcing, and last-minute changes to components.
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Prototype and Validation Risks: There may be issues with first article verification, or real-world stress testing may uncover issues that were not discovered in the validation process.
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Manufacturing and Design Transfer Risks: There may be challenges in transferring a design that is proven to work in the prototype stage to a production process, due to varying assembly, tooling, and requirements.
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Reliability and Failure Risks: Failure to consider operating conditions may lead to early product failures and customer dissatisfaction.
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Cost and Schedule Risks: Design changes, repeated testing, substitution of components, engineering and manufacturing related challenges may result in an increase in the cost of development and may lead to delays.
A proactive risk management process helps engineers determine unanticipated obstacles programmatically while they are still comprehensively addressing these obstacles.
Reasons Why Risk Management Is Important
Implementing risk management in an organization helps in early recognition of potential issues, evaluation of impact, application of appropriate controls, continuous monitoring of risks during the product life cycle, and improvement in product safety and reliability.
1. Improves Product Safety and Reliability
During the design and development of the product, evaluation of risks helps engineering teams identify hazards and weaknesses so that design controls are introduced prior to the product's manufacture or sale.
2. Identifies Problems Early in Product Development
Risk Management is a proactive approach to identify possible product risks and avoid unwanted failures. To illustrate, identifying risks during early design and build processes grants engineering teams an opportunity to evaluate the design and build processes and consider numerous alternative approaches to the design and build.
3. Supports Better Design Decisions
Risk management gives product development teams another structured way to evaluate engineering decisions. This approach helps integrate risk considerations directly into product design and design control activities.
4. Strengthens Design Controls
Risk management and design control should work together. Risk analysis can identify hazards and potential failure modes, while the resulting risk controls can influence design requirements, design outputs, verification, and validation activities.
5. Reduces Manufacturing and Design Transfer Risks
Manufacturing and design transfer can bring about critical risks due to changes in materials, suppliers, equipment, processes, inspection methods, documentation and production conditions. A product that may have performed successfully as a prototype may encounter critical problems while manufacturing at the production scale.
6. Helps Prioritize Critical Risks
The risks relative to impact are not always the same. The purpose of risk management is the structured prioritization of risks based on the impact, likelihood, detectability, and other corporate criteria.
Our Risk Management Process - How We Work
We cover the six steps of our risk management process, from defining your organization’s risk appetite to developing a management system.
Objectives and Risk Tolerance
To understand the context of your goals and the risk appetite of your organization.
Identifying Hazards
Research and data analysis are augmented with competitive analysis and expert review to generate a comprehensive list of plausible product-related risks.
Prioritizing Risks
Each risk is scored for likelihood and severity. This is done in conjunction with a risk assessment matrix and shown to the client to provide a clear and visual sense of the major areas of concern.
Controls
Most effective risks control measures are implemented with the design, process, control and other features of the product. The appropriate balance is achieved between risk, cost, design, ease of use and time to market.
Control Validation
Controls are integrated into the design and confirmed via a test, simulation or assessment to provide the mechanism to reduce risks to an acceptable level.
Continuous Improvement
Post-launch replacement of old risk management systems is implemented to meet new market demands and maintain competitiveness.
Why Use Reliability Quality Solutions?
Hands-On Engineering Knowledge
Our teams understand the challenges and trade-offs that occur at the intersection of design and manufacturing. We focus on finding and addressing real-world problems instead of just providing documentation.
Risk-Centric Approach
We direct our efforts to the risks that can affect a product’s quality, reliability, and performance and that can impact a product’s cost and time to market.
Integration Across Disciplines
Design transfer spans engineering, manufacturing, quality, suppliers, and operations. We help join these separate disciplines and foster risk-integrated collaboration.
Evidence-Based Judgement
We employ engineering data, failure data, FMEA, testing, process data, and other objective evidence in our decisions and recommendations.
Prevention Over Cure
Manufacturing issues found after production begins are generally costlier and time-consuming to correct than those found before manufacturing begins.
From Design to Production
Our goal is not just to provide recommendations. We provide an integrated engineering partnership to help organizations for design, development, verification, validation, production and transfer.
Reduce Risk Before It Reaches Production
A successful design transfer does not happen by simply moving documents from engineering to manufacturing.
Identifying product risks, manufacturing risks, process risks, reliability risks, quality risks, and the specific combination of risks and how they relate to the controls placed to manage those risks is necessary to develop a deep understanding of those risks.
At Reliability Quality Solutions, we help organizations build that connection. From risk management in product design and product development to design control and design transfer, our engineering team can help identify risks earlier, strengthen controls, improve manufacturing readiness, and support a more reliable path to production.
Contact UsFrequently Asked Questions
What is risk management in design transfer?
Risk management in design transfer is managing the risks that accompany the transition of a product design from the drawing board to the production ecosystem. It maintains the alignment of design requirements with manufacturing processes and controls, as well as production documentation.
Why is risk management crucial in design transfer?
Design transfer carries the risk of new manufacturing process risks, new supplier risks, new material risks, new equipment risks, new risks in the methods of inspection, new risks in process documentation, and new risks in process capability. Managing these risks before the design is transferred to actual production helps to avoid defects and minimize production delays, rework, reliability problems, and even likely non-compliance issues.
What does risk management in product design entail?
Prior to manufacturing, product design risk management consists of identifying potential risks and opportunities in the product, followed by introducing appropriate controls that reduce these identified risks/opportunities.
What does risk management entail in product development?
In product development, risk management is an iterative process that reviews risks as requirements and designs progress, along with the evolution of prototypes and technologies, as well as the introduction of potential suppliers and manufacturing processes.
How does risk management support design control?
Risk management provides inputs and outputs for design control, thus helping to establish a traceable connection between product risks and design control risks.
What tools are used in design transfer risk management?
Depending on a given product and project, tools may consist of FMEA, risk assessments, reliability analysis, fault analysis, process capability analysis, process validation, design reviews, testing, and a structured risk-control evaluation.
Is FMEA sufficient for design transfer risk management?
No, FMEA can only be one part of design transfer risk management. FMEA as a risk analysis methodology is invaluable; however, design transfer risk management spans multiple other processes and activities, including risk, design and manufacturing controls, verification, validation, process capability, documentation, and management of remaining risks.
What industries require design transfer risk management?
Design transfer risk management is most applicable to industries and sectors that manufacture products with a significant impact on the quality and reliability of the finished product, including the medical device, aerospace, automotive, electronics, and other engineered product sectors.
Can Reliability Quality Solutions cover our entire design transfer process?
Yes, Reliability Quality Solutions can support organizations with risk assessment, FMEA, reliability analysis, design control, manufacturing readiness, process validation, risk control, and other activities related to the transfer of a product from development to manufacturing.
What is risk management in product design?
The process of risk management in product design consists of locating product design risks, estimating the possibility of risk exposure, and designing controls to manage the identified risks before making the product available for use.
Why is risk management important in product development?
Risk management in product development prevents the product from causing harm to users, fulfills regulatory compliance associated with the FDA, ISO, and other similar standards, lessens legal exposure, improves product quality and reliability, and reduces the potential for costly product recalls.
What's the difference between risk assessment and risk management?
Risk assessment is the process of evaluating and identifying potential risks. Risk management, on the other hand, concerns the evaluation and risk control, capture, and surveillance processes.
What are the tools used for the management of risk during the process of product design?
Tools and techniques used for risk management include Failure Mode and Effects Analysis (FMEA/DFMEA), Hazard Operability Analysis (HAZOP), Finite Element Analysis (FEA), Probabilistic Risk Assessment (PRA), and risk assessment matrices.
Is Risk Management a requirement of the FDA?
Yes. For medical devices. The FDA's 21 CFR 820.30 design control requires risk analysis to occur as part of the design validation, and most manufacturers align with this requirement by ISO 14971.
What is the cost of a product design risk assessment?
The product complexity and the applicable regulation will determine the cost. A full FMEA or an ISO/FDA risk management file is typically much more cost-efficient than a post-launch product recall.
At what stage of the product development should risk management be initiated?
It should be done as early as possible, ideally during concept and requirements development, and not as a result of developing a product prototype.
Can risk management assist in preventing a product recall?
Yes. Studies of medical device recalls have shown that most were due to design or process deficiencies that could have been addressed by design controls and risk analysis.
What are risk assessment matrices?
Risk assessment matrices are tools that evaluate the likelihood and impact of different hazards. They help teams better understand which hazards can be addressed to prioritize mitigation.
How does risk management relate to quality control?
Quality control is focused on the final product and ensuring it meets specifications. Risk management happens during design; it focuses on preventing the creation of hazards in a product.
