Results of Integrating Quality with the Design Process
You want to design the best products and you're ready to use quality and reliability methods.
You're concerned that a consultant will interrupt your existing design process or add a band-aid fix and leave.
With my partnership, you and others on your senior business team get aligned with how you want to get from where you are to where you want to be.
These solutions can become a routine part of your design process. Integrating quality tools can start as a supplement to what you already do, and it works into helping you make decisions.
Below are some real-world, individual case studies of taking an existing system and expanding the use of quality tools and methods to achieve great outcomes, within the design team and outside of it.
Case Study #1: Decide and Communicate Design Specs Based on Risk
- the company could focus controls on critical features and make decisions on part acceptability based on risk
- engineers dimensioned product drawings for inspection
- QA and engineers set inspection levels to have a direct correlation with the criticality of part features
- the supplier understood which features needed to be controlled within their process (for their process capability)
- Supplier Management understood the criticality of the vendor and adjusted their supplier controls
- post-market surveillance teams can trace part failures to features and understand what types of controls are managing the risks of part failure
Engineers were creating design specifications for injection molded parts for new product development. The molded parts were supplied from a vendor, but the design was controlled in-house. The team needed to identify which features were critical for the supplier to measure for their process validations and what ongoing quality controls were necessary.
The project had an existing design FMEA (failure mode effects analysis) for the parts being developed. The design FMEA had potential effects of failures associated with both the functionality of the design and the potential harm to the users and the environment.
The solution strategy was to use the design FMEA to identify the features that were critical to safety or functionality, based on the FMEA severity levels. Those features that were critical would be measured during process validation and/or monitored by incoming QA inspection.
Along with the design engineer, we chose the features that were critical and identified those on the part prints. Dimensions were also labeled to be measured for process validation and/or QA inspection; different dimensions were labeled based on the risk level and engineering knowledge of plastic injection molding. The AQL (acceptable quality level) for QA at incoming inspection was also changed: critical features required a tighter/more stringent inspection, and other non-critical features were removed from inspection or their AQLs loosened. Process validation and QA inspection controls were added to the design FMEA, which reduced the overall FMEA priority rating.
"Dianna is a skilled quality professional who has exhibited highly valued leadership characteristics based on essential planning and critical thinking. The ability to understand a given situation from a high level and to then set in motion the needed actions to achieve success is an important trait that Dianna has demonstrated specifically in regard to the safety, efficacy, and compliance of medical devices. This approach would be highly valued for an organization since it exemplifies a reasoned and constructive thought process to obtain desired goals."
Frederick A. Yeagle, Principal Engineer Quality and Reliability, medical device industry
Case Study #2: Get Clarity to Make Informed Decisions
There was a pending change to instructions for a product. The initial edit to the instructions was prompted by outside requirements. But, the edits also involved a change in how information was presented to the users. The team wanted to better understand what information was critical to convey based on product performance, success rates in product use, and safety.
I developed a strategy to use the exisiting FMEA (failure mode effects analysis). The FMEA already had use errors within its scope (I had confirmed that known field events were listed in the FMEA). Because of this, we could work from the FMEA to analyze potential use errors more closely.
I facilitated working meetings with a cross functional team. We worked from a draft of the user's process flow and the FMEA.
Through finishing the process flow map of the user's steps, the team clarified the different user groups, use scenarios, and the purpose of each step.
The team also completed a task analysis. They first linked each user step with both a potential use error in the FMEA and also the information needed to complete the step successfully. Then, they combined the information to link specific labeling information with potential harms and severities.
Results & Outcomes
The team met its goals, which were to:
- confirm which process steps were critical tasks (associated with harms of a certain severity)
- confirm what information from labeling is needed at each step for it to be completed successfully
- evaluate the proposed labeling changes against the level of risk
The team used the results of the analysis to determine what information needed to be in the labeling and how to best present it, based on risk. They also developed action items to further mitigate risks. In addition, the analysis was available as an input into labeling validation protocols to help define scope of test and acceptance criteria.
"I had the pleasure of working closely with Dianna in my role as MDR Project Manager for Teleflex. Dianna demonstrated leadership and tremendous competence in all of her activities. I was impressed with her deep knowledge of the subject matter and her commitment to meeting deadlines. I am happy to recommend her to others."
Jim Watkins, MDR Project Manger
Case Study #3: Use Proven Reliability Methods to Assess the Situation
A complex fault was occurring in an electromechanical device. There were combinations of product state and use scenarios that, if happened simultaneously, could trigger the event. There was an existing risk file with FMEA (failure mode effects analysis), so the severities of the effect were already previously estimated. The team needed to get to the root cause of the issues to address the problem and to understand the likelihood of this event.
I worked with engineers and field operations to create a fault tree analysis, mapping the events to their root causes. I performed research of whitepapers and other published sources to estimate the likelihood of base events that would occur during use. Using published data sources gave credibility to the outcome of the analysis. I then calculated probabilities of possible scenarios that could lead to that event. I facilitated meetings with engineering, quality, and field operations to create, review, and discuss the results of the analysis.
Results & Outcomes
Through mapping out the root causes with engineers and field operations, the root causes and complex scenarios became more clear to the team.
Because of the visual map, a broader audience was better able to understand the combinations between product and environment that could cause a fault. This led to productive discussions on how to address the root problem.
The information was fed back into the existing FMEA for a benefit-risk decision.
Case Study #4: Engage with Suppliers and Other Departments
- Supplier Management could better vet potential suppliers based on mitigations needed to control risk
- the potential suppliers understood the criticality of the plating process
- QA inspection levels had a direct correlation with the criticality of part features
- it is clear on within design control documents that the plating is critical, why it is, and what types of controls are managing the risks of failure
Engineers were within an iteration of design development and needed to make a design change. Instead of an off-the-shelf switch, the engineers needed a custom switch. New specifications were needed and vendors needed to be identified.
The project had an existing risk file with a design FMEA (failure mode effects analysis) for the parts being developed. The design FMEA had potential effects of failures associated with both the functionality of the design and the top-level risks, or hazards, to the users and the environment.
The solution strategy was to use the design FMEA to identify the features that were Critical to Safety and/or Critical to Functionality, based on the FMEA severity levels.
Using the design FMEA, we determined that the metal plating was a critical feature that needed to be controlled by the supplier's processes. A supplier quality plan was drafted. The engineer chose ASTM plating standards and referenced them on the part print. The ASTM standards also referenced typical inspection methods for platers. The AQL level was aligned with the risk in the design FMEA, added to the part print, and the suppliers were asked to provide that information in a certificate of compliance.
Would you like to achieve these types of real results and powerful outcomes in your business?
I'd love to offer you a free confidential strategy session with me to help you achieve your product design goals and identify how I can accelerate your success.
After our consultation you will: