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QA6640 Chat Room Transcript February 7, 2007

Prof. Atkins 20:14:16
The chat room is closed for this evening. It will reopen next Wednesday at 7:35 PM.

Prof. Atkins 20:09:36
If there are no questions, we can close the chat room for this evening.

Prof. Atkins 20:06:59
The thirty-minutes are over. Responses posted after this message appears will not be evaluated for chat room participation credit.

All students will receive chat room feedback and grades on Module Assignment One sometime during the day tomorrow, on Thursday.

If you have a question, you may ask it at this time.

Komic 20:03:17
Control of Quality Management

I performed the process Audit of the Steris Isomedix facility in Spartanburg, South Carolina in December, 2006. This facility provides sterilization services, using Gamma Irradiation for Cardinal Health Snowden Pencer Desposable Insufflator Tubing Sets. Because Steris provides services that are of crucial importance for safety of the sterile product we are required by our internal procedures to audit Steris quality system once a year. As a part of the Quality System Audit I looked at the Steris’ control of Quality management.

As per BSI Student Manual Control of Quality Management includes: identification of the QMS processes needed and application, determine process sequence and interaction,
available recourses, monitor measure and analyze processes, implementing action to achieve results, and identification of the sources of any outsource processes

Steris holds ISO 13485:2003 certification. A quality management system audit covered quality system elements and Cardinal Health Snowden-Pencer Products specifications that are associated with ISO 13485:2003. The audit focused specificly on the effectiveness of the quality system as it relates to gamma irradiation. Cardinal Health Supplier Evaluation Checklist was used as guidance for the audit.

Corresponding procedures from the Steris Quality Policy Manual were examined to insure that management provide evidence of commitment to develop implement and maintain an effective QMS.

Management review of te entire quality system must be performed and documenting on the scheduled basis. Action items from the management review meetings must be followed. Management must insure quality policy appropriate, communicated and understood by all.

el hamraoui hanane 20:03:13
Hanane El Hamraoui
helhamra@spsu.edu
Chapter 5 discussion question

The company I chose is Intel Corporate and the principle of the eight 5 I chose is control of acceptance.
To prevent non-conformity, Intel Corp. does a control of acceptance yet named control of inspection, measuring, and test equipment.
Intel has an extensive network of calibration laboratories located at all major sites to ensure the capability of all instruments used to perform measurements during manufacturing. This network maintains or has access to standards for measuring a wide range of parameters critical to semiconductor manufacturing such as voltage, current, resistance, frequency, mass, light intensity, dimensions, etc. Every instrument at each site is tracked and placed on a calibration schedule. A traceability process links system for document- and engineering change control. The Document Control Management System allows incorporation of external and internal customer requirements for quality assurance, assessment and improvement into the manufacturing operations. http://lifelong.engr.utexas.edu/emc/pdf/quality.pdf

For example, Intel® NOR Flash Memory models provide an accurate snapshot of silicon behavior through the use of software simulation tools. These models speed the design validation process, helping to ensure that design goals are properly met prior to committing to PCB layout. Understanding design issues early enables quick correction, improves product performance and reliability and reduces development costs. With successful designs enabled faster, products can reach the market sooner for a potential increase in market share.

IBIS models are used for verifying the PCB layout design and understanding the impedance characteristics of devices. Typical IBIS examples include output buffer drive strength and slew rate verification, inter-component flight time testing, and variable output compensation management across components. Hardware Description Language (HDL) models, such as VHDL and Verilog, are used to validate components and system logic operation through AC timing analysis and functional testing. Intel provides access to HDL memory model components through Denali Software, Inc.* Denali models are tested by Intel to ensure accuracy to Intel specifications.

gstevens 20:00:39
Module 4 Question
Date: February 7, 2007
Student: Glenn Stevens
Email: anandale@comcast.net

Company Selected: LHS was in the business of developing software products for the telecommunications market place. The primary product developed was used for customer account management, call rating and billing of wireless and wire-line services.
Concept: Control of Quality Management. This concept focuses on the infrastructure established by an organization to ensure that the way it produces and develops its products are governed by quality directives. That is the goal of doing the right things right the first time. Additional goals are to reduce waste, increase efficiency and continuously increase the quality of the work and the products developed and delivered. The use of benchmarking, certification with quality standard organizations such as ISO, SEI CMMI, and Malcolm Baldrige National Quality Award Criteria provide companies with quality frameworks in which to work.

Example: LHS was insistent that it delivered its software products within budget, on time and with the least amount of product defects. The quality management framework organization was headed by a VP reporting into the CIO. The organization of the Quality Assurance Group, consisted of a quality assurance director, software test director. The quality assurance director headed up a team consisting of quality assurance analysts and engineers. The software test director headed up a team of software test engineers.

Roles: The Quality Assurance Team was responsible for the creation and maintenance of processes, documentation of standard procedures and best practices. They also conducted compliance audits to ascertain how well the software development teams were adhering to the established processes.

Processes were developed collectively with the working teams and posted. These consisted of the following: process areas (Planning, Requirements Definition, Analysis, Design, Construction, Testing and Shipping). Each process had a brief description, a purpose, entry and exit criteria, underlying steps and actions within each step. For each action an actor or role was assigned. The process document also included input work items for the process as well as output work items. Across the full span of the software development life cycle, toll gates or critical checkpoints were created. Each checkpoint was usually established between phases. Each process also had a quality appraisal function, which may consist of reviews, inspections, walkthroughs or testing. Upon the completion of every software development project, a post project review was held that entailed determining those activities and functions that were executed well, and those that are in need of improvement. A project score card was created and the data from each project collected in a data base to be applied to future projects. One goal would be to identify the 5 top most areas for improvement and ensure that these were covered in the next product development release.
Metrics were maintained that were used to measure the number of defects or findings detected at each phase of the development life cycle. These were stored in a database and use for continuous quality improvement. Metrics such as defect removal efficiency (% of defects found and removed in each phase), defect density (defects found per product feature.

The software testing team maintained a data base of defects and for every resolved defect root cause analysis was done. The root causes were then shared with the teams with the intent that these would not be replicated. The main philosophy was to: prevent defect, detect and remove defects early. Each team member was trained in the art of the quality program “There is no QUALITY without U”.

Gleiter 20:00:26
Kimberly Gleiterkgleiter@hedonline.comHE produces electronic devices with numerous components. When the final product is found to be nonconforming, a great deal of trouble-shooting pursues to try to find the root cause of the problem. Control of procurement is essential as it may entail a significant amount of resources (people and equipment) on HE’s end to get to the bottom of an issue. In some cases, HE is expending resources to merely establish which component is causing the problem. Once this is determined, the true root cause is sought out in partnership with the supplier. Though in the end the nonconforming parts can be returned to the supplier for credit, the trouble-shooting costs incurred are not recuperated. If a supplier has their own supplier program, it can serve as one of the best ways to control and improve quality to prevent nonconformities. As Bossert put it, “the end product is only as good as the raw materials that go into it.” (41).

Natasha_Romero 20:00:20
Here is a re-post that is a bit easier to read. Sorry about that.

Natasha Romero
nromero@spsu.edu

Control of acceptance

1. I currently work for Sandia National Laboratory. We are a contractor to the Department of Energy and Department of Defense. Our mission is national security. We design both embedded and non-embedded software systems.

2. Control of acceptance can best be described as verification and validation. Validation asks “Are we building the right product?” and verifications asks “Are we building the product right?”

3. In my work environment we use requirements documents to validate if we are building the right product. This type of document is written by us and reviewed by our customer to ensure that we have the correct requirements or specifications for the product we are designing. We do a round of System Testing once the product has been built to determine if we have met the customer requirements. The system test plan and procedure are based on the requirements document to validate that we have met each one of the customer’s requirements. There is traceability between the requirements documentation and the system test plan and procedures. We also verify that we are building the product right. This done through specification documentation as well as Integration Testing. Specification documentation takes our requirement documentation and describes technically how the requirement will be met. We then do testing to ensure that the product is working as we have designed it to work. There is a cycle of testing, updating specifications and product until there is a final product. The overall process is that we write requirements, write specifications, build product, conduct integration testing, conduct system testing and release product. Other parallel processes occur such as working on the system plan and procedure once the requirements documentation has been finalized (signed off by the customer).

Brad McGuire 19:59:54
QA6640
Brad McGuire
bmcguire@spsu.edu

1) I will again be using Lockheed Martin Aeronautics in Marietta, GA as my example company.
2) I will discuss the concept of “Control of measuring instruments” as it relates to the Laser Gap Gun QA measuring device that is currently utilized in F-22 Final Assembly.
3) The QA Laser Gap Gun is a relatively new measuring device that Lockheed Aero-Marietta has been using for nearly 2 years. This measuring tool is currently used in lieu of more traditional feeler and step gauges on aircraft panels. Feeler and step gauges were used to measure the step and gap of panels as they were final installed on the aircraft. These types of gauges rely directly on the inspector to correctly judge what the panel step and/or gap are. As the text states on page 42, “Inspection and testing are only as good as the precision, accuracy, and reliability of the measuring instruments”. These types of gauges rely heavily on the personal judgment and skill of the inspector and are therefore susceptible to the human error factor. This is exacerbated by the curved surfaces of the aircraft. Many surfaces of the jet are very difficult to stand on, much less accurately measure. However, the Laser Gap Gun, besides being extremely user-friendly, is highly precise (measuring step/gap to within .0001), accurate, and reliable. The Gun employs both a laser and miniature-camera that is mounted on the end of the gun. Each time the operator aims the gun, lines up the laser over the panel seam, and pulls the trigger, the camera takes 12 pictures of the seam and measures each to ensure exactness. Further, as I witnessed, the only variable that may lead to inaccuracies or un-reliability is the manner in which it is held relative to the panel. This variable is easily overcome by a simple training session that takes less than a half-hour. The measuring technique is literally a “point-and-shoot” method that is a highly controllable, reliable, and accurate measuring instrument that ensures quality.

el hamraoui hanane 19:59:23
Hanane El Hamraoui
helhamra@spsu.edu
Chapter 5 discussion question

Rich Weaver 19:58:47
5. Control of manufacture

Bossert is exactly correct when he states that ‘uncontrolled processes result in waste and excessive variation. I will discuss several of the ways that General Motors attempts to ‘control manufacture’ at a truck assembly plant.

The first element in the control of manufacture is the planning that takes place prior to manufacture. When a new product line is launched, a large board is set up, and the operations in a supervisor’s group are graphically laid out on the board. Through this process mapping, problems are often uncovered before the job is physically realized.

The workstation is verified that there are no known ergonomic stressors or safety risks. A preliminary set of job instructions are drafted, with the involvement of the Team Member and the Team Leaders. Their experience is extremely useful in determining what is feasible, and there are usually a host of good suggestions on the job set-up. The job instructions are documented in the operator’s JES (Job Element Sheet) and SOS (Standard Operating Sheets). Visual aids are provided to illustrate proper installation, and to document accept / reject criteria. If there is a mandatory sequence called out for a particular element, this is noted as well.

If power tools are required, they are certified for use (correct torque, RPM). The supervisor must fill in a checksheet weekly verifying that the correct power tool is present at the operation.

The material layout is verified, and all part presentation apparatus (wire baskets or roller racks) are labelled with the correct part numbers.

For certain critical operations, error-proofing devices may be installed. Two examples are ‘pick-lights’ that will identify the correct emblem to install on the vehicle. There is an operation on which the Team Member must remove a pair of needle-nose pliers from a holster to crimp over a cotter pin. If the light screen does not ‘see’ that the pliers have been removed, an alarm sounds when the vehicle leaves the footprint.

As a communication tool, and as a means for the operator to summon assistance when needed, an Andon cord is positioned overhead. But pulling the Andon cord, an visual or audio signal is broadcast to let the Team Leader know that there is a problem.

Lastly, critical operations are included in what we call ‘Layered Audits’. The Team Leader must verify operation once a shift, the supervisor has to do the same on a weekly basis, and members of the plant staff received Layered audit assignments monthly to go out and verify several operations.

Finally, data management systems are in place to feed back quality information from downstream Verification Stations to the Group and Team for corrective action.

Chris Wellman 19:57:25
Chris Wellman

Control of quality management

I have chosen a Company called Sxxxxxxx, they have a small group that has primarily done support work for a Government Laboratory. I have not provided the real name of this company due to the sensitive nature of what I will discuss. That work involved repair to units that have failed in the field or conducting installation of those repaired units. The personnel are primarily personnel who were formerly members of the Military with technical backgrounds that gave them good knowledge of working on the Government platforms they serviced.

I will discuss Control of quality management. I will use an example to demonstrate the effectiveness of different techniques to ensure a supplier has a system of quality management that will support your needs.

Our normal practice is to ask a new supplier about their Quality management system. In this case we decided to partner with Sxxxxxxx because of the great familiarity they had with the type of work we were bidding on. During the initial stage the only step that was taken was to conduct a survey, which asked specific questions about provisions the supplier had for a Quality Management system as well as what standard their system complied. The company gave all the right answers so they were allowed to bid on the Job.

When our company felt sure about the chance of getting the work I was assigned to the program. One of the first tasks I did was to travel to our major suppliers and partners who were not certified to ISO 9001:2000. First I reviewed their Quality Manual against the standard and found it compliant. Then I asked to see their procedures, which I planed to pick out specific samples and then audit against actual work they were performing for the Government.

When I asked for the procedures for how the complied with the standard they all had the deer in the head lights look. I immediately knew we were in trouble. I have struggled with this matter now for well over a year trying to coach this supplier to implement the procedures necessary to reduce variability in their work product. There is some improvement, but it has been limited significantly, since their Management does not fully support the process. They are working with a third party to get certification to the standard, but very slowly.

The moral of the story is that a simple survey in not adequate and it takes a systematic on-site audit for prospective new suppliers before you make that commitment.

J Scott 19:57:23
Control of Measuring Instruments

The company I chose to discuss measurement quality is Delta Air Lines. Being a former aircraft maintenance technician, I understand how vital it is that precision measuring equipment be maintained in constant calibration. Defects in measuring equipment can have dramatic, if not catastrophic effects on an aircraft and it passengers.

The program used is termed the Precision Measuring Equipment & Tooling (PMET) program. This program ensures the integrity of precision measuring equipment by establishing a process for tracking, calibration and feedback.

Tracking is conducted via a networked program. Each precision measuring tool is identified with a tooling number and logged into the data base. When tools are 10 days out from calibration, an electronic message is generated to the applicable tool room to remove the tool from service and turn it in. A copy message is also generated to an assigned QA person who monitors the program. The QA person ensures the integrity of the entire PMET program. When the tooling is received by their ISO certified calibration lab, the lab technician is required to receive the tool in the system. This provides a tracking mechanism for every tool. Feedback is provided by the lab technician for any tool that is found out of calibration by a significant amount. The tool room is then able to determine what aircraft this tool was used on and what specific job it was used on. This scenario rarely happened, but it was an added control measure to ensure a sound program.

Additionally, any time a tool was checked out from a tool room, the tool room attendant would perform a “bump test” using field calibration instruments.

Given the controls in place for secure storage, tracking, calibration and secondary controls for oversight and redundancy, the PMET was a sound program that contributed to the overall effectiveness of the quality system.

James Scott .

Alan Dial 19:54:06
Briefly describe the company you have chosen.

Aero Gear was established in 1982 and has grown to be a leading producer of precision gears for the aerospace industry. Committed to improvement, Aero Gear supplies customers such as Pratt & Whitney, Hamilton Standard, Sikorsky Aircraft, Raytheon and Boeing.
Douglas Rose – President
John McDermott – V.P. Sales/Marketing and Director

Briefly describe the concept you will discuss.

I intend to discuss Aero Gear’s “Control of measuring instruments” of its suppliers. Aero Gear’s Quality Plan mandates that its suppliers maintain an effective system of control of any the suppliers or its vendor’s measuring, test or calibration equipment that is used as a method of final acceptance on Aero Gears supplied parts. The procedure shall include but not be limited to the following:
• Traceability to material standards requirements.
• Location of charge out equipment.
• Recall system.
• Recall intervals, including basis for establishment of interval and adjustment of interval.
• Disposition of obsolete and inaccurate equipment.
• Environment test condition (where applicable).
• Required accuracy.
• Certifications of outside calibration source.

The “Control of Measuring Equipment” system directed by Aero Gear also prescribes the requirements surrounding controlled area for the equipment and documentation retention.

Use a specific example to help explain the concept, and include as much detail as possible without exceeding the thirty-minute time limit for your response.

I will reference examples from my experience as an ISO Auditor why this is so important. The traceability of the calibration equipment is not limited to the sites equipment. Many times, for time critical maintenance periods, the facility will bring in a team of contractors to perform calibrations on its site. Often times, capturing the calibration records are not retrieved on the contractors calibration and measuring equipment. The calibration records for the contractor equipment should contain the approved NIST test method utilized to calibrate the test equipment. This allows auditors and the site leadership to have traceable records from the plant equipment all the way back to NIST. Since the site is an ISO certified facility, these records are needed to ensure plant equipment is operating correctly and are tested in accordance with accepted testing protocol and maintain certification with its Registrar. Much of the calibrated equipment that the sites maintain records on are critical to the safety and operation of the plant. Failure of this equipment could cause significant damage to the plant or harm to the sites personnel. As well, if an incident occurs, the Customer and the supplier may go into litigation and the calibration records protect the supplier as well as give them confidence that they are providing adequately for its Customer.

Aero Gear Company Homepage. Retrieved from http://www.aerogear.com/equipsvc.htm on February 7, 2007.

Michael Ginn 19:52:20
Michael Ginn
Email: ginnmichael@hotmail.com

7. Control of measuring instruments

The company I will reference to is a tier two automotive supplier (CNC Machining). I worked there as a quality manager. This company is a smaller batch/job shop (35-40 employees). It had a couple of jobs that ran every day, but the rest of the parts were job shop stuff. I say this to explain how important the control of measuring instruments is.

If a plant is under any kind of quality standard (QS-9000, TS-16949, or ISO) then the control of measuring instruments is covered under the standard. Normally, the standard will require the company to prove the scope of their in house calibrations, and anything outside the company’s scope must be calibrated by an independent calibration lab. The independent calibration lab must be accredited to a calibration standard. Calibration is not the only control used for measuring instruments. An instrument must also me accurate enough for the measurement taken. Repeatability is also another control. Repeatability must be proven through annual gauge R&R studies.

Example: In our lab, we had Coordinate Measuring Machines (CMM) which would measure in a graduation of a micron. We didn’t have any way to calibrate this instrument in-house, so an independent lab would calibrate it once a year at our plant.

All measuring instruments calibration records are also required to be kept for the life of the instrument. This will show the quality personal or auditor the life of the gauge. It would show (trend) if the gauge is starting to wear or not holding to the desired calibration standard.

Prof. Atkins 19:34:54
Chat Room Discussion Question:

You have thirty-minutes to answer the following chat room question:

In the fifth chapter of “The Supplier Management Handbook” the author states that the best way to control and improve quality is to prevent nonconformity. The author then lists and briefly discusses the following eight ways this can be accomplished:

1. Control of quality management.
2. Control of design improvement.
3. Control of procurement.
4. Control of material.
5. Control of manufacture.
6. Control of acceptance.
7. Control of measuring instruments.
8. Use of quality information.

Select any ONE of the above eight concepts and discuss it in detail as it applies to a specific example that you are familiar with. You may discuss your example in context to any ONE of the following:

The company you now work for, or
a company you have worked for before, or
any company you are familiar with.

Your discussion should cover the following three issues:

1. Briefly describe the company you have chosen.
2. Briefly describe the concept you will discuss.
3. Use a specific example to help explain the concept, and include as much detail as possible without exceeding the thirty-minute time limit for your response.