Ctq critical to quality pdf files

Critical to quality tree ctq template results washington. Simply put, ctqs are characteristics that the product or service must have to satisfy the customer. Identify how your customers evaluate quality in your products or services. The definition we use at imation for ctq criticaltoquality is as follows. 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. Name examples of the critical to quality ctq requirement. 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.

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. 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. 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. Four months later, the agency followed up by issuing a communication to device manufacturerscritical to quality ctq indicators. Ctqs are the most important, measurable characteristics of the finished product that are strongly linked to customer requirements. Critical to quality, or ctq, trees are used to help see the characteristics of a product from a customer point of view.

Finally, you identify measurable performance requirements that each driver must satisfy if youre to actually provide a high quality product to your customers. Source the lean six sigma pocket toolbook critical to quality. They align improvement or design efforts with customer requirements. Waiting time in clinic spelling mistakes in letter % of valves leaking in operation 31. Exploring the critical to quality ctq factors clinical. Chris mcmillan, senior corporate performance analyst, city of fayetteville, north carolina, discusses the use of this tool to explain performance measurements to staff outside of the traditional quality department and how the city government is going about introducing quality throughout its systems. 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. Name examples of the criticaltoquality ctq requirement. Critical characteristic symbol quality forum and business.

Dec 17, 2019 in 6 sigma, ctq is an acronym that stands for criticalto quality. Understanding and applying critical to quality principles. An important term that we use in lean six sigma is critical to quality characteristic, or ctq. 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. Instrument critical to quality matrix ctq rkw kompetenzzentrum. A ctq tree is an approach of linking measures to an important outcome. We encourage you to further explore the various critical to quality factors ctqs by selecting categories on the image to the left. A critical part requirement specified on the engineering document, typically a drawing, specification or performance requirement. 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.

You can then use these requirements to deliver high quality products and services. Its a very versatile tool and it wasnt long before i came to realize the broad scope of its application. May 03, 2019 this requires the team to determine the critical to quality ctq customer requirements. Pdf product design for six sigma dfss approach is a structural and disciplined methodology driven by critical to quality characteristics ctqs. Recognize an alternate term for a swimlane process map.

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%. Critical to quality ctq critical to quality characteristics are defined as. 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. It shows how ctqs relate to higherlevel concepts such as performance indicators and strategic. These outputs represent the product or service characteristics defined by the customer internal.

Division pilot 1 asd branch 4 1 cd branch 2 pond branch 1 1 rego branch 1 total ctq information documents. Identification of specific, measurable critical to quality ctq characteristics is essential for meaningful and measurable business process improvement. This document is intended to be a discussion tool, not to serve as a checklist. 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. Use an affinity diagram to sort ideas and find themes. Critical to quality describes the processes involved in providing customers with a positive product experience. Ctqs are whats important to the quality of the process or service to ensure the. The team also identified that these issues are critical to quality ctq for patient safety.

In this lesson, youll learn more about critical to quality components and. The pairwise comparisons are set up in matrix format as shown in tables 1 and 2. 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. Explainer video for ctq critical to quality youtube. It aims to make explicit and structure the rationale underlying the project.

And one of the top priorities for fdas medical devices center is a focus on quality. In 6 sigma, ctq is an acronym that stands for criticalto quality. It is a good idea to identify the critical to quality parameters as they relate to. How would you challenge the firm to determine that ctq. Ensure compliance to critical manufacturing process requirements supplier quality critical to quality focus. How to use a ctq tree with six sigma villanova university. The internal critical quality parameters that relate to the wants and needs of the customer. Scope of testing optional basically, quality department is liableto determine cope of testing the s. Using a spec document and qfd for ctq list the qfd institute. 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.

Deficiencies are not all critical to quality ctq u. Top quality medical devices help the fda better protect and promote public health. Ctqs are a set of measurable criteria for quality as seen through the eyes of the customer. An example of a critical to quality tree diagram strategy tools from. 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. Innovating critical process manufacturing oversight. Ctq s are useful in helping product designers and manufacturing teams know where to focus their efforts in designing robust products and processes.

Once you have captured voc, you can then translate this information into ctq s. Fda and device quality critical to quality ctq dmq 2014 efforts fda news quality congress cdrh update pma ctq info. Using the principles document should be a thinking exercise, not a check the box exercise. Introduction to production part approval process ppap. In 6 sigma, ctq is an acronym that stands for critical to quality. 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. Identify customer and project ctqs critical to quality characteristic by focusing outward on the. Critical to quality ctq trees are used for the projection of customers needs on a specified product.

Standardize, streamline, and improve state agency processes. Critical to quality ctq trees translating broad needs to requirements. The ctq checklist is a tool frequently used by lean. Criticaltoquality describes the processes involved in providing customers with a positive product experience. Gather voice of customer voc data relevant to product or services. 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. There is no qs9000 standard critical characteristic symbol that i am aware of. The ctq tree diagram can map specific requirements to key drivers of quality and on to a specific measurement. The definition we use at imation for ctq critical to quality is as follows. 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. They are not the same as ctcs critical to customer, and the two are often confused. Study ctq critical to quality risks and define what do we need to start doing with ctq critical to quality.

Conduct further customer contact as needed to establish quantifiable targets. Ctqs are important when attempts have been made to understand the customers needs in order to tailor services and products to those needs. In this lesson, youll learn more about criticaltoquality components and. Once you have captured voc, you can then translate this information into ctqs. Identify relevant statements in transcripts of customer. Improve quality with a ctq focus support support support industry approach to process validation included in medaccred audit criteria. Critical to quality ctq is the quality of a product or service in the eyes of the voice of the customer voc. 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. Derived from dfmea pfmea fda case for quality focus. Critical to quality ctq or critical to quality characteristics ctqc. A critical process requirement that is identified by alto shaam, i. Ctqs are used to decompose broad customer requirements into more easily quantified elements. Critical to quality characteristics service at asu. Critical to quality ctq trees help you translate broad customer needs into specific, actionable, measurable performance requirements.

Ctqs are useful in helping product designers and manufacturing teams know where to focus their efforts in designing robust products and processes. 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. 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. 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. 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. 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. Ctq trees were originally developed as part of the six sigma methodology. Recent improvements in coatings for intravascular devices. Medical device manufacturers must take a variety of requirements into consideration as they strive to provide safe and reliable products.

Relate how to compare variation in process performance. 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. Ctqs can include anything from the dimensions of a physical product to the promptness of delivering a service. In this bright hub article, learn what a ctq tree is, as well as an example on how to go about making one. Six sigma is quality management philosophy used by many successful companies. 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. Having one for your business or company will help knowing what your customers are looking for. Supplier qualitypurchasing controls successful practices. Pdf technical decomposition approach of critical to quality.

Ctq diagram example critical to quality tree example. Six sigma professionals refer to this as voice of the customer or voc. An overview in some recent lean training, i was introduced to the powerful concept of a critical to quality ctq checklist. Spc control charts the supplier will monitor ctqs variable and attribute as well as inprocess control parameters via spc control charts. This requires the team to determine the critical to quality ctq customer requirements. Also see appendix c of qs9000 for symbols and explainations. A commonly used tool to go from a project definition to these specific and measurable ctqs is the ctq flowdown. Each critical feature has to be consecutively numbered on the drawing.

Additionally, it is not uncommon for designers to identify features that are ctq critical to quality on an engineering drawing. Ctq critical to quality, critical to quality, business process, ctq tree, design for six sigma, quality, total productive maintenance, total quality management. 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. In fact, the concept seems applicable even to training itself. 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. Visioctq pilot qsr callouts to advamed ctq library roadmap. The purpose of the ctq tree diagram is to systematically link customer requirements to key performance indicators kpis. Specific factors or attributes that are associated with customers. A ctq is a critical to quality product feature that must be maintained in order to meet customer expectations. 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.

319 445 811 930 610 30 1326 746 667 1208 416 835 1269 38 455 906 120 807 1118 931 1453 1109 128 845 529 1453 69 1035 1191 988 807 789 961 722 1091 682 68 1179 1465 899 535