A commonly used tool to go from a project definition to these specific and measurable ctqs is the ctq flowdown. They align improvement or design efforts with customer requirements. A ctq tree is an approach of linking measures to an important outcome. Critical to quality ctq critical to quality characteristics are defined as. In this lesson, youll learn more about criticaltoquality components and. Additionally, it is not uncommon for designers to identify features that are ctq critical to quality on an engineering drawing. Critical to quality ctq is the quality of a product or service in the eyes of the voice of the customer voc. Exploring the critical to quality ctq factors clinical. How would you challenge the firm to determine that ctq. It is a good idea to identify the critical to quality parameters as they relate to. Specific factors or attributes that are associated with customers. Conduct further customer contact as needed to establish quantifiable targets.
Ctq trees were originally developed as part of the six sigma methodology. Ctq trees criticaltoquality trees are the key measurable characteristics of a product or process whose performance standards or specification limits must be met in order to satisfy the customer. Critical to quality ctq verification and report as agreed and defined in the qcp, at a minimum the following ctq inspections and deliverables will be required. Critical to quality tree ctq template results washington. The ctq checklist is a tool frequently used by lean. Critical to quality ctq, customer critical feature ccf those features are to be observed particularly, if they may result in a loss of operational safety, if they are not being carried out according to drawing specifications. There is no qs9000 standard critical characteristic symbol that i am aware of. Critical to quality, or ctq, trees are used to help see the characteristics of a product from a customer point of view. Using a spec document and qfd for ctq list the qfd institute. It aims to make explicit and structure the rationale underlying the project. Capturing ctqs early in the product development lifecycle provides a traceable body of knowledge. Standardize, streamline, and improve state agency processes. Often the critical customer requirements are not stated in a way that can be measured internally therefore ccr needs to be translated to the critical to quality ctq, which can be measured in the agency note. A ctq is a critical to quality product feature that must be maintained in order to meet customer expectations.
We encourage you to further explore the various critical to quality factors ctqs by selecting categories on the image to the left. Ctqs are useful in helping product designers and manufacturing teams know where to focus their efforts in designing robust products and processes. Customer requirements, which are identified as ctqs, are actually a handful of elements which are considered critical to the executive team in determining the success of the projectproductprocess. Ctqs are the most important, measurable characteristics of the finished product that are strongly linked to customer requirements. The definition we use at imation for ctq critical to quality is as follows. Supplier qualitypurchasing controls successful practices. Criticaltoquality describes the processes involved in providing customers with a positive product experience.
Fda and device quality critical to quality ctq dmq 2014 efforts fda news quality congress cdrh update pma ctq info. This requires the team to determine the critical to quality ctq customer requirements. It provides a high degree of visibility to quality, customer requirements, critical process points, and the importance of variation reduction, helping us to vastly improve organizational. It shows how ctqs relate to higherlevel concepts such as performance indicators and strategic. Deficiencies are not all critical to quality ctq u. Identification and control of critical to quality product characteristics product ctq s dfmea control and variability of product ctq s design transfer flow down of ctq from oem to suppliers firsttier and subtier process risk controls identification and control of critical to quality process characteristics. Relate how to compare variation in process performance.
Critical to quality ctq or critical to quality characteristics ctqc. Hydrophilic coated and hydrophobic coated vascular and neurological deviceswhich identified common features of coated devices that have the greatest impact on device safety and effectiveness, and how these. Spc control charts the supplier will monitor ctqs variable and attribute as well as inprocess control parameters via spc control charts. Pdf product design for six sigma dfss approach is a structural and disciplined methodology driven by critical to quality characteristics ctqs. Instrument critical to quality matrix ctq rkw kompetenzzentrum. Critical to quality ctq trees translating broad needs to requirements. The team also identified that these issues are critical to quality ctq for patient safety. The ctq tree diagram can map specific requirements to key drivers of quality and on to a specific measurement. When youre developing new products and services, quality is important not only to satisfy your clients, but also to help you stand out from your competitors. Six sigma professionals refer to this as voice of the customer or voc. Simply put, ctqs are characteristics that the product or service must have to satisfy the customer. These outputs represent the product or service characteristics defined by the customer internal.
After starting a project and gathering the voice of the customer voc, it is time to define the criticaltoquality outputs ctqs ctqs are the key measurable characteristics of a product or process whose performance standards or specification limits must be met in order to satisfy the customer. An overview in some recent lean training, i was introduced to the powerful concept of a critical to quality ctq checklist. Critical to quality ctq trees help you translate broad customer needs into specific, actionable, measurable performance requirements. Pdf technical decomposition approach of critical to quality. Explainer video for ctq critical to quality youtube. Ctqs are whats important to the quality of the process or service to ensure the. Once you have captured voc, you can then translate this information into ctq s. Once you have captured voc, you can then translate this information into ctqs. Based on special requirements, such as functional relevant tests, the responsible design engineer is allowed to determine the scope of testing for these features to 100%. Save your finished work file save as to our cloud repository for future access, or to export your diagram as image jpg, png, pdf, svg, etc and share it with your.
Recent improvements in coatings for intravascular devices. Also see appendix c of qs9000 for symbols and explainations. In this bright hub article, learn what a ctq tree is, as well as an example on how to go about making one. In order to understand what a ctq is, and the role it plays in services, we have to start with the concept of deterministic reasoning.
Ctqs are important when attempts have been made to understand the customers needs in order to tailor services and products to those needs. Innovating critical process manufacturing oversight. Ctq diagram example critical to quality tree example. Top quality medical devices help the fda better protect and promote public health. May 03, 2019 this requires the team to determine the critical to quality ctq customer requirements. They are not the same as ctcs critical to customer, and the two are often confused. Gather voice of customer voc data relevant to product or services.
Critical to quality characteristics ctqs are the productservice characteristics that are important to the customer from the customers point of view, and ctq is measurable characteristics whose performance standards or specification limits must be met to satisfy the customer requirements. The critical to quality characteristics ctq are features by which customers evaluate a product or service and can be used as measures for a six sigma proje. Introduction to production part approval process ppap. Identify how your customers evaluate quality in your products or services. And one of the top priorities for fdas medical devices center is a focus on quality. The internal critical quality parameters that relate to the wants and needs of the customer. Translates the voice of the customer s voc language into a measurable specification so you can tell whether or not the ctq has been met. Critical to quality characteristics service at asu. In 6 sigma, ctq is an acronym that stands for criticalto quality. By reducing the force required to manipulate intravascular medical devices during vascular interventional procedures, hydrophilic coatings reduce risk of damage to blood vessel walls and prevent vasospasm. Ctq s recent case studies of three highneeds schools in an urban district suggest that finding ways to engage parents or in their absence, the resources of the broader community for supporting the school financially or with volunteer assistance are critical to the success of school improvement plans and student achievement gains. Recognize an alternate term for a swimlane process map. Ctqs critical to quality are the key measurable characteristics of a product or process whose performance standards or specification limits must be met in order to satisfy the customer.
Critical to quality ctq trees are used for the projection of customers needs on a specified product. Improve quality with a ctq focus support support support industry approach to process validation included in medaccred audit criteria. Six sigma is quality management philosophy used by many successful companies. You can then use these requirements to deliver high quality products and services. Derived from dfmea pfmea fda case for quality focus. In fact, the concept seems applicable even to training itself. Ctqs can include anything from the dimensions of a physical product to the promptness of delivering a service. Identify relevant statements in transcripts of customer.
Scope of testing optional basically, quality department is liableto determine cope of testing the s. Ensure compliance to critical manufacturing process requirements supplier quality critical to quality focus. In 6 sigma, ctq is an acronym that stands for critical to quality. Critical characteristic symbol quality forum and business. In this lesson, youll learn more about critical to quality components and. Ctq s are useful in helping product designers and manufacturing teams know where to focus their efforts in designing robust products and processes.
A critical part requirement specified on the engineering document, typically a drawing, specification or performance requirement. Visioctq pilot qsr callouts to advamed ctq library roadmap. Name examples of the criticaltoquality ctq requirement. Four months later, the agency followed up by issuing a communication to device manufacturerscritical to quality ctq indicators. Name examples of the critical to quality ctq requirement. Each critical feature has to be consecutively numbered on the drawing.
Using the principles document should be a thinking exercise, not a check the box exercise. Ctqs are used to decompose broad customer requirements into more easily quantified elements. A brief tutorial missouri miechv gateway continuous quality improvement training ctqs are a set of measurable criteria for quality as seen through the eyes of the customer. The definition we use at imation for ctq criticaltoquality is as follows. Division pilot 1 asd branch 4 1 cd branch 2 pond branch 1 1 rego branch 1 total ctq information documents. A critical process requirement that is identified by alto shaam, i.
Ctq trees critical to quality trees are the key measurable characteristics of a product or process whose performance standards or specification limits must be met in order to satisfy the customer. Study ctq critical to quality risks and define what do we need to start doing with ctq critical to quality. Use this section of the form to identify the critical to quality ctq need, preferred value, assessment value, and average score for each ctq item. The pairwise comparisons are set up in matrix format as shown in tables 1 and 2. The bare necessities of life for a medical device an approach to identifying critical requirements through the development of key product characteristics and critical to quality items. Ctq c ritical toquality ctq characteristics for the process, service or process measure of what is important to customer six sigma projects are designed to improve ctq examples. Critical to quality flowdown ctq design for six sigma tools qfd ctq flowdown translate voc into technical requirements identify the critical characteristics that contribute to the technical requirements measure process capability for each critical characteristic compare capability ppk to cp and determine status. How to use a ctq tree with six sigma villanova university. A process characteristic or component that has a direct effect on whether the overall process or product is perceived by the customer to be of acceptable quality. Having one for your business or company will help knowing what your customers are looking for.
After starting a project and gathering the voice of the customer voc, it is time to define the critical to quality outputs ctqs ctqs are the key measurable characteristics of a product or process whose performance standards or specification limits must be met in order to satisfy the customer. An example of a critical to quality tree diagram strategy tools from. Ctqs are a set of measurable criteria for quality as seen through the eyes of the customer. Finally, you identify measurable performance requirements that each driver must satisfy if youre to actually provide a high quality product to your customers. Waiting time in clinic spelling mistakes in letter % of valves leaking in operation 31. Ctq critical to quality, critical to quality, business process, ctq tree, design for six sigma, quality, total productive maintenance, total quality management. The form for a real estate re project transaction shows this section if the include evaluation scoring in ctqs field in the application settings record is set to yes. Critical to quality describes the processes involved in providing customers with a positive product experience. Its a very versatile tool and it wasnt long before i came to realize the broad scope of its application.
The purpose of the ctq tree diagram is to systematically link customer requirements to key performance indicators kpis. This document is intended to be a discussion tool, not to serve as a checklist. Use an affinity diagram to sort ideas and find themes. Understanding and applying critical to quality principles. Dec 17, 2019 in 6 sigma, ctq is an acronym that stands for criticalto quality.
312 989 29 1130 1284 64 1231 556 418 1493 983 1165 45 34 611 455 1237 272 972 1094 373 129 802 675 1495 758 125 776 9 121 217 1384 202 888 1279 1252 837