Understanding and Applying Critical to Quality Principles

Transcription

1 Understanding and Applying Critical to Quality Principles Phil Pontikos, FDA Investigator, Medical Device National Expert Ben Dastoli, FDA Investigator, Medical Device Specialist Steven Niedelman, Lead QS & Compliance Consultant, King & Spalding Bleta Vuniqi, CDRH, Quality System Specialist Moderated by: Gina Brackett, FDA Compliance Officer 1

2 Agenda PMA Critical to Quality Pilot Program Discuss Critical to Quality (CtQ) concepts Discuss CtQ linkages to design, purchasing and risk analysis Interactive group exercise 2

3 PMA CtQ Pilot Program Announced September 11, 2017 in Federal Register Description: The pilot allows a PMA device manufacturer meeting the participation criteria to engage on new PMAs early in the review process and discuss and identify CtQ characteristics Joint effort between the CDRH and ORA Limited to 9 participants Assessment: This voluntary PMA CtQ pilot program does not represent a new requirement Cost: Modifications: No additional cost to manufacturer FDA intends to forego conducting a preapproval inspection, which it would usually conduct, and instead conduct a more focused post-approval inspection. Benefit: Promote quality in device manufacturing, early engagement, and timely review of the PMA manufacturing section FDA also believes that focusing on features and characteristics considered critical to the safety and effectiveness of the device may lead to fewer device failures, a decrease in device recalls, and improved device innovation and efficiencies. 3

4 Critical to Quality (CtQ) Established as part of CDRH s Case for Quality initiative CtQ device characteristics are attributes that are considered critical to product or process quality, or key measurable features of a product or process whose performance standards or specification limits must be met in order for the product to meet customer needs and intended use. Firms implement mechanisms to ensure that those features/characteristics important to the user are consistently met. 4

5 Critical to Quality (CtQ) the key output characteristic of a process. An example may be an element of a design or an attribute of a service that is critical in the eyes of the customer. - Implementing Quality: A Practical Guide to Tools and Techniques. By Ron Basu A CtQ is a product or service characteristic that must be met to satisfy a specification or requirement. - Six Sigma Best Practices. By Dhirendra Kumar Its purpose is to start with the high-level strategic goal of customer satisfaction and determine how this goal flows down into measureable goals. - The Certified Six Sigma Handbook. By TM Kubiak and Donald W. Benbow 5

6 Critical to Quality Important Quality System Links: Design Controls Purchasing Controls Risk Management Production and Process Controls Post-Market Surveillance 6

7 Critical to Quality What CtQ means in terms of implementation: Drawings Specifications Tolerances Features Components Labeling Service Packing/Shipping Assemblies/Sub-assemblies Manufacturing Process Validated Processes Risk Management Purchasing Controls Could be anything related to design outputs! 7

8 Which of these may also be 1) Cost savings initiatives 2) Installation 3) Instructions for use 4) Routine maintenance 5) Two of the above related to CtQ? 8

9 Design Verification vs. Validation Design Verification, in it s simplest terms is the OBJECTIVE evidence that a design input has been met! Physical measurement such as weight, circumference, dimensions or tolerances Measured as an output, such as radiation (greys), voltage, resistance, strength or flexibility Testing of the device. Do all the features work as intended 9

10 Design Verification vs. Validation Design Validation - Did you build the device you had intended for the end user. Examples: Un-biased users, not involved in the initial design, evaluating the device to ensure it meets its intended design Confirm that Human Factors (as identified in inputs) have been met Beta- testing is an example 10

11 Design Verification vs Validation True, False or No Idea? Design validation must be conducted outside your facility to obtain un-biased feedback. 1) True 2) False 3) I have no idea 11

12 Linking Design Activities to CtQ Elements CtQs are tested throughout the design process CtQs can affect essential functioning and/or safety of your device 12

13 CtQ Potential Impact on Different Areas of Quality System Affects the level of acceptance activities / supplier controls needed Affect on production processes including verification or validation of the processes Correlation and alignment with your risk analysis Communication and training to appropriate personal 13

14 Short Term Understanding of Memory Potential (STUMP) Are all items related to the safety of the product CTQs? 1) Yes 2) No 3) Probably 14

15 Short Term Understanding of Memory Potential (STUMP) What about the converse, are all CTQs safety related? 1) Yes 2) No 3) Probably 15

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17 Puzzle Time If you had a homogenous metal plate with a hole in its center, and uniformly heat it for a finite time, what will happen to the diameter of the hole? 1) Stay the same size 2) Increase in size 3) Decrease in size 4) Form into a square 17

18 Potential Affected Areas Related to CtQ Design risk analyses Design inputs; Design outputs In-process inspections/testing Design verification Design validation Design transfer Production and Process controls Process validations CAPA Acceptance activities Sampling plans Evaluations of supplier Supplier corrective actions Management Reviews 18

19 Proactive vs Reactive What type of system have you developed? 19

20 CASE STUDY Mobile Tachyon Imaging Device Developed by CHI Technology Quorp 20

21 Case Study Introduction Tables will work independently Odd number tables will be the Regulators Even number tables will be Chi Technology Quorp 21

22 Case Study Introduction The odd number tables which are the Regulator tables will be tasked with preparing to conduct an inspection of Chi Technology Quorp Chi Technology Quorp has just implemented the CtQ concepts into their quality system This will be the first inspection since their implementation of CtQ concepts Each table will elect a spokesperson to represent the table 22

23 Case Study Introduction The Even number tables will be Chi Technology Quorp You are being tasked with identifying CtQs and describing how you are incorporating the CtQ concept into their quality system. You will be identifying characteristics that are critical and then how the characteristic will be controlled. Each table will elect a spokesperson to represent the table 23

24 Case Study Introduction Each group has a copy of the specific instructions to follow for this case study The case study includes a role play by Ben and Phil describing the device, its technology and its intended use From the role play, you will be able to derive key concepts 24

25 Case Study Introduction CHI Technology Quorp, specializes in tachyon imaging technology systems You have recently received an FDA PMA approval for your class III imaging device The device is a portable, handheld imaging unit used to diagnose ischemias, blood clots and tumors in patients The device emits invisible tachyon particles/waves, generated by Tri-lithium crystals in order capture imaging data. 25

26 Role Play 26

27 The Device Class III, PMA, Mobile Tachyon Imaging Device Developed by CHI Technology Quorp 27

28 Accessories Charging Station Protective Eyewear 28

29 Accessories Image Processing Station HAL-2018 HAL

30 The Science Behind the Device 30

31 Tachyons 31

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33 The Tachyon Particle/Wave 33

34 The Science 34

35 Advantages Portable: Can be used in ambulatory or military use settings Provides real time imaging Low operating cost. No dedicated room needed Superior detection of ischemic events and tumors without the need for secondary confirmation Once and Done technology No needles, contrast dyes or drugs needed 35

36 Adamantium Shield Primary fingerprint power initiation Visualization Port Bi-lateral On/Off Buttons Scan area selection wheel Calibration Port AIM acquisition image monitoring Secondary fingerprint power initiation Power Output Display Scan Button Bluetooth Dicom communication port Variable exposure time Charging Port 36

37 Accessory: Protective Eyewear Tachyon Neutralizing Strip Crimson Crystalloid Coating Nasal Support Arch 37

38 Accessory: Charging Station for Mobile Imaging Device Analogue Amp Rate Meter Knob and tube fuse /holder Variable Charge Time (seconds) 38

39 Accessory: Computer Resolution Transmitter (CRT) display Video Hi-capacity Storage (VHS) STINC Software for Tachyon Imaging Network and Connection BlueTooth Receiver 39

40 Power Capacity Limiter Tachyon echo sensor Random space/time stabilizer Stabilization dampening discs rear LOGIC BOARD Tesla integrated timing system Tri- Lithium Crystal Stabilization dampening discs front Redundant timing chip Tandem azure spheres Flux generation unit Nebulous Internal Processor 40

41 Tri-Lithium Crystal 41

42 Indications for Use IFU: The device is a portable, handheld imaging unit used by healthcare practitioners to diagnose ischemias, blood clots and tumors in patients The device emits invisible tachyon particles/waves, generated by tri-lithium crystals The device transmits the data to a workstation for viewing and image storage. 42

43 Safety Issues: Safety Concerns There is limited data on this novel tachyon technology We know that tachyon beams can cause burns, tachyon radiation syndrome (Tachiosis), and internal cellular damage Concerns for both patients and users depend on the angle of reflection Optical Rods and Cones have been found to be particularly sensitive to tachyons There is a mandatory two week minimum wait time between scans. 43

44 Safety Concerns (cont.) Tachyon waves /particles can create an unstable rift in time and space As part of the PMA review, FDA performed a benefit/risk analyses, and concluded that its superior imaging, portability outweighed the lack of available data on serious adverse events, therefore the benefits outweighed the risk and thus granted approval. 44

45 Actual Tachyon Scan Images Lack of Circulation Images must be read and interpreted by a *certified Tachyologist AND Radiologist. * Currently only CHI Quorp offers certification 45

46 Actual Tachyon Scan Images Tumor Circulation Problem Circulation Problem 46

47 Case Study The CEO, Dr. Manhattan, has just returned from Medcon where he attended a presentation on CtQ elements by FDA employees and world renowned consulting firm Queen and Rawling. His keen business sense and obsession with quality help him quickly decide to pursue implementation of CtQs at the company. He tasks your group with identifying and managing CtQs for the portable imaging device. 47

48 Chi Tech Group Your task is to implement the CtQ principles into the Quality System. Based on what you have learned and the role play, answer the following questions. Identify and list at least 5 design elements that your group considers to be CtQ characteristics and be prepared to discuss your rationale for the selection. How would you implement CtQ principles? Identify key areas you would focus on to ensure that the CtQ program was implemented and controlled. What controls would you put in place to ensure that the CtQs are implemented? What monitoring mechanisms would you include to ensure CtQs were implemented and functioning as intended in your quality system. How would you disseminate the CtQ principles to the employees? 48

49 Regulator Group Your task is to prepare for an inspection of Chi Technology Quorp. You have just learned that the firm has recently implemented CtQ principles into their quality system for the first time. Based on what you have learned and the role play, answer the following questions. What questions would you prepare ahead of time to ask the firm during the inspection related to CtQ principles? What criteria and principles were applied by CHI Technology Quorp when identifying CtQ criteria to this device? What procedures and documents would you request to review pertaining to CtQ principles? How would you challenge the firm to determine that CtQ principles were implemented throughout the quality system? Which individuals by job function or job title would you want to interview related to CtQ principles and why? 49

50 QUIZ TIME Which of these movies or TV series was not represented in this presentation?? 1) X-Men 2)2001 A Space Odyssey 3) Star Wars 4)Star Trek 5)Back to the Future 6)The Watchman 50

51 Summary CtQ principles affect virtually all aspects of the Quality System Proper implementation requires proper identification and dissemination of the CtQs Understand that change control can impact the CtQs 51

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