“Top management must have a “quality control strategy, firm policy, standards, guidelines and clear instructions for middle level management, for designers, for manufacturing, quality control, maintenance, operators and all others involved in the transformation processes, that generate wealth for the company (Ranky). All employees must understand and be trained in quality control strategy, quality policy, standards. Across the company all employees must understand quality is everyone’s job and priority. One of the company’s objectives is to keep their ISO certification. “The organization will establish, document, implement and maintain a quality management system in accordance with ISO 9001.)” The company will ensure as part of the ISO 9001:200 the following are within the intent of the document: “Quality Management System, Management responsibility, Resource Management, Product Realization, Measurement Analysis and Improvement”

Besides instituting a culture that accepts high quality, a company must institute total quality management and total control subsystems. The eight quality management principles that a company should follow are ISO standards. These eight quality management systems are the following: customer focus, leadership, involvement of people, process approach, systems approach to management, continual improvement, factual approach to decision making, mutually beneficial supplier relationships. I think equally as important as having a total quality management approach is having total quality control subsystems. These subsystems are described in e-learning test book and include the following subsystems: purchase control, process control, control of manufacturing information, control of operators, control of process steps and process capability, control of finished product, control of measuring instruments and test equipment and control of corrective action. All employees must understand the importance of these quality control systems.

Also, all employees will have to prepare the following for projects, new products, and services. CORA, PFRA and process control carts. Furthermore, the company must have continuous improvement procedures in place and include in performance measure continuous improvement objectives. Also, the vendors and contractors will have continuous improvement procedures in order to do business.

The company will ensure their total quality plan and control standard will be correct prior performing ISO9001 audits. Below are ISO 9001 questions and answers to how the Flores’ Fifth Company adresses each issue.

Purchase Controls

How do they select their suppliers (i.e. cost, service, quality)?

I agree with the E-learning text book where choosing reliable supplier to obtain the correct material is important. In addition, how and where materials are stored are also important. The fifth company does not really get into the business of storing the material. The added advantage of the fifth company is pull data-Kanban business model which is used. Therefore, large quantity material does not get stored by the fifth company thus eliminating that variable.

Most importantly, choosing a reliable vendor is critical function for the fifth company. I would issue contracts to suppliers that are certified ISO 9000 and conduct audits according to ISO900:2000 standard. Furthermore, upon awarding contracts I would ask for company’s quality credentials and attempt to access companies quality experience based on past experiences. A section of project bid would be to show applicable quality project standards to which project would be performed. By doing above I will be able to determine if quality standards are aligned with mine.  In addition, I would attempt to have a program similar to BOEING’s where each supplier has a continuous improvement system. My continuous improvement system would be modeled after Boeing’s system. The supplier will be required to include performance measures, such as measures of waste, quality, cycle time, and customer satisfaction. Furthermore, The organization shall conduct periodic management reviews of the system, paying close attention to the performance measures, and modifying improvement activities as necessary (Ranky).”

I think the cost may be higher for a supplier to support quality requirements, but in the long run higher quality will lead to lower costs for the fifth company.

Are they ISO 9001:2000 certified suppliers?

The fifth company would like to use ISO 9000 certified suppliers, but my understanding is having an ISO 9000 certification does not necessarily men that a higher quality product is being delivered. My understanding is an ISO 9000 certification guarantees the company follows the prescribed standards. Wikipedia indicates “Certification to an ISO 9000 standard does not guarantee the compliance (and therefore the quality) of end products and services; rather, it certifies that consistent business processes are being applied.” In any case certification would be a plus to win contract, but I would also try to develop a testing mechanisms that identifies a company has high quality internal practices. One way of doing is work with the suppliers as a partnership.(http://en.wikipedia.org/wiki/ISO_9000)

Are they on the certified suppliers list? What procedures do they / should they follow?

Yes, the fifthc company must be on an approved certification list internally in the company. Prior to being able to work for the company a series of reviews, training and inspections would be conducted prior to contractor getting on the certified contractors list. The fifth company would ensure the company follows federal, state and local laws. Furthermore, the company being an ISO certified company would have to follow ISO 9000:2000. Wikipedia writes “placing the concept of process management front and centre. ("Process management" was the monitoring and optimizing of a company's tasks and activities, instead of just inspecting the final product.” In additon, I would also have the suppliers follow ISO/TS 16949:200 which is automotive industry-specific requirement to follow.

Audits

Have these suppliers ever been audited by the fifth (i.e. your) company?

The fifth company does perform audits of the suppliers. The fifth company audits the supplier to find the system is working as the supplier reported they would work. According to Wikipedia, the purpose of the audit is “aim to continual process the review and assessment, to verify that the sytem is working as it supposed to, find out where it can improve and to correct or prevent problems identified (Wikipedia).” However, the fifth company encourages the suppliers tp perform internal audit of their organization. This internal auditing is part of the continuous program identified above. The fifth company will audit to verify with our own eyes. Less frequent auditing by the fifth company will occur if the suppliers provide sound internal audits.

Was it done by mail or on-site?

Auditing is done onsite. Furthermore, to have a lasting partnership the fifth company, also a supplier, would encourage my customers to participate in an audit so they can have piece of mind they hired the right company that will ensure their parts and service will be provided at the highest quality. As the fifth company I would like to participate in their audit. This will also give me insight if the company is also keeping up with their continuous improvement system. I think seeing an audit with your supplier may be a useful idea even though it may not be as common. The only thing I would be worried about participating in a scheduled audit is that I would be afraid their best face is being put on during the audit. Therefore, I would like for the fifth company to perform a surprise audit. In addition, prior to a facility winning a bid, I would request a visit to see that the part they say is manufactured is being manufactured according to the quality standards they specified in order to win the bid.

I think mail would be less likely for the fifth company to perform because the criticality parts require the fifth company to perform an onsite audit.

Incoming Inventory Inspections

Does QA inspect every incoming materials purchased or do they rely on the supplier’s certificate of analyses or conformance (COA/COC)?

The fifth company has an added feature where RFID has traceability of parts. Therefore, the parts the fifth company will be involved with have RFID writable tags with quality results and data in tag and can be easily red by a RFID reader. Therefore, likelihood a failure occurs and a non confirming parts goes into assembly is slim. RFID reduces the risk a non conforming parts goes into assembly line or makes it to the customer.

As part of the fifth companies Total Quality Management system the fifth company has in place. The fifth company will perform Quality Control, review, inspection and documentation. The fifth company will also ensure they are meeting Total Quality Management goals.

The fifth company relies on RFID technology to ensure incoming parts with writable tags are read with RFID readers and report parts are conforming. The fifth company will not rely on suppliers’ certificate. The only time the fifth company will rely on the certificate of analyses or conformance is after the supplier has proven high quality management processes, demonstrated seriousness in continuous improvement system, fifth company has witnesses successful supplier self auditing, and supplier has passed successfully a fifth company’s audit several times.

Do they accept materials without certificates of analyses? What procedures do they / should they follow?

The fifth company parts come with writable RFID tags that provide the quality result and indication part conforms. Therefore, the fifth company does not accept any other certificate analyses that are not incorporated into the writable tags.  The fifth company will ensure the suppliers at a minimum follow ISO9000 and ISO/TS 16949:200

Non-conformance

How does the fifth company address non-conformance related to incoming materials, in-process goods, and finished goods. What procedures do they / should they follow?

Traceability

Can they trace all materials from grave to cradle per say? Do they use RFID? Would RFID benefit them?

Yes the fifth company provides a service where they allow their customer to trace their product from cradle to grave. Parts at each stage of the way (assembly line or process) through RFID can wrote tags and place writable tags on the parts detailing quality data such as acceptable tolerances, pressures, temperatures, and or process variable limits. The writable tags are read by RFID reader tags transmitted to through integrator and computer and information is stored in a database. The part as long as it has a RFID tag and tag is not damaged, the reader will pick up within it s radio frequency between it store, shop and supplier. The RFID tagged part as it leaves the suppliers and goes to the  manufacturers store and floor, the manufacturer will be able to read the RFID if manufacture is on the same radio frequency. Theoretically, the RFID can reach all the way to the consumer retail store and if the RFID tag with part is not damaged the consumer retail with their RIFD can read RFID tagged.  For example, the fifth company will provide a RFID and software integrated service between General Motor, Teleflex, AIM, and MDSI where Teleflex part will start to be manufacture at Teleflex process line. At each identified strategic-critical stage a RFID writable tag with quality and part data will be placed on the manufactured part. The manufactured part will go to General Motors’ store and will be read and by a RFID reader and logged into their parts database with al the information Teleflex placed on the RFID writable tag. As the part is used through General Motor assembly and it becomes a part of a bigger component another tag will be placed with the quality data and component data. This will allow each part and component with writable RFID tag to be traced through out the process using the fifth companies RFID service.

What procedures do they follow?

The fifth company uses procedures they developed from ISO 9000 and ISO/TS 16949:2002. The standards above identified, the fifth company will have procedures that will address the use of following: FPRA, CORA, CIMMpgr, “supplier system development, statistical process control, control plan, product quality planning (Wikipedia).” Furthermore, “documented procedure to control quality documents and provide all access to these procedures for all to use (Wikipedia).” 

The fifth company established “Operational procedures, describing the core working instructions and procedures for quality control purposes (Ranky).” The fifth company’s quality policy is to use the developed procedures and train the entire organization in the use of these procedures ensuring all hands understand the quality level the fifth company will work under.

In addition, the company uses procedures the fifth company identified as part of their continuous improvement program. The objective of continuous procedure similar to Boeing’s where “procedures take into account enterprise-wide needs and is applied in a way that provides consistency and standardization of improvement efforts (Ranky)."

Controls of production documents

Who maintains this documentation? Are they controlled? Who reviews them? What procedures do they / should they follow?

Control of production documents are all the fifth company employee responsibility. At any point in the process production documents may be involved in the process, so all employees should ensure the control of production documents are 100-percent correct. The fifth company has a large responsibility that to aid the Operations group maintain Control documentation accurate. Fifth company RFID technology tag readers located at workstations display instructions to direct operators and also capture Quality Control signature for each stage of production. The instructions have been approved as part of the quality control program where quality standards, policy and plan are adhered to in the instructions. Fifth company service becomes a partnership with Operations and Quality Control allowing for accurate documentation and traceability. The fifth company facilitates the responsible parties have their quality information captures accurately real time with out human error interface.

 The department that should ensure the production documents and procedures are maintained correctly are the owners (Operations Department) of the production and the Quality Control department. Furthermore, the auditing team should conduct an audit to ensure the standards and procedures operations group agreed to follow and perform are being done. In addition, in my opinion the auditing group should audit themselves as well as external group audit the quality control/audit departments. For example, I think the Operations group should have the ownership and responsibility to maintain their control documents. The Operations group should have the advice and counsel of the Quality Control if it needs. I know this may seem difficult to achieve to have an Operations group can have quality ownership as good as a Quality Control department, but in my opinion, if there is no quality ownership of Operations group than there may only be slight evidence that there is a Total Quality Management culture. In the ideal case Operations group and Quality Control group for an ongoing steady state should be one and seamless. Quality Control would then be conducting auditing to ensure this process is running at a highest quality possible. In addition, the Operations group should be conducting self auditing and following their continuous improvement documentation.

As indicated above the Operations group reviews themselves with a checklist they have prepared themselves or based on a previous auditing checklist Auditing had prepared. The checklist should be based on ISO 9000:2000. In addition, the Operations group should review their procedures in a two year cycle review. Operations group should have training for all employees on the Quality Control and Total Quality Management expectation and standards. The Operators and Engineers have to have own nest and high quality priority. I think even though the own nest is on the Operations I think an established partnership with the Quality Control groups must be solid, where training, procedures, policy, acceptable conformity, and traceability are incorporated in all aspects of the job.  

Controls of Production Equipment

Such as qualifications, validation, calibration, etc. What procedures do they follow to establish such controls?

My understanding is the fifth company helps the stakeholders achieve validation and calibration traceability through out the entire process. The fifth company allows this by using RFID technology.  My understanding is controls of production equipment are part of total quality control of subsystems and is important to ensure total quality management. According to Professor Ranky’s  E-learning text book, control of equipment must have “calibrations and periodic maintenance of test and process equipment for adequate control are essential. Error of measurement studies are often used to prove-in an instrument and to monitor its accuracy and precision level during use.”

According to Wikipedia website, http://en.wikipedia.org/wiki/Calibration , “is the process of establishing the relationship between a measuring device and the units of measure. This is done by comparing a devise or the output of an instrument to a standard having known measurement characteristics.” My understanding is the devise the equipment is compared to is traced pack to another standard. The formal comparison standard used in the USA is National Institute of Science and Technology (NIST) or certified reference materials such as ISO 9000 and ISO/IEC 17025. According to Wikipedia website, http://en.wikipedia.org/wiki/ISO_17025,  ISO/IEC 17025 is the main standard used by testing and calibration laboratories. After a device has been calibrated in a work station the fifth company because ot its writable tag allows for the Operations group to create a RFID tag or ad information to the tag to incorporate the equipment was calibrated. The fifth company will also create tags for any of its equipment it has to calibrate.

According to Wikipedia validation is “Validation implies one is able to document that a solution or process is correct or is suited for its intended use, and usually relates to confirmation that the needs of an external customer or user of a product, service, or system are met.” The fifth company helps the General Motor and Teleflex validate their products because the fifth company’s RFID technology allows users to capture their quality data to validate their product fit for use. In addition, the fifth company’s pull data-RFID Kanban technology will also require to be validated the hardware and software meet the fifth company’s validation criteria prior to use. In addition, the fifth company has to validate their sites and software is secure. The fifth company will validate their process following the ISO 9000 standard.

In the product realization, each company should test process limits to standards that are regulated by federal, state local laws and or industry code/standards such as American Society of Mechanical Engineering if applicable. For example, a process that has state regulation on water discharge will test their equipment and their process as described in state law. Another regulation would be a car would have to meet car emissions standards. My understanding it would be unlawful for car manufacturer to sell a car that does not reach current emissions standard. Therefore, this car manufacturer would want to test for this regulation prior to sell. My understanding is that are automotive professional standards for automotive engineering such as S.A.E. Handbook by Society of Automotive Engineers. Similar, the fifth company can follow a Software Engineering Standards Institute of Electrical and Electronics Engineers and a IEEE standard for Software Quality Assurance Plans (ANSI/IEEE std 730 1984). The fifth company to conform to quality would also follow IEEE standards because they have software and electronics.

Product Realization

Are they meeting their promises? Are they any deviations? Change controls? What procedures do they / should they follow?

The fifth company incorporates total quality management and ISO standards for product realization. The fifth company final product realization will be performed by the fifth company’s Quality Assurance team. The fifth company will follow the applicable ISO standards. The fifth company being a certified ISO 9000 company will conduct a Product Realization following the documentation requirement guidelines in ISO 9000: 2000. Based on my research of ISO 9000: 2000 product release is done by following the criteria Product Realization ISO 9000:2000 which is “verify planning and development of the process is evident and is consistent with requirements. Also the fifth company ensures the following is determined and met before product release: quality objectives and requirements of the product, the need to establish process, documents, and provide resources specific to products, required verification, validation, monitoring, inspection and test activities specific to the product and the criteria acceptable, and records needed to provide evidence that the realization processes and resulting product meet requirements?

In addition, to the fifth company will also meet ISO/IEC 90003:2004 standards. This standard is not necessarily specific to product software release but is part of the total quality management system the fifth company has framed within the company. According to ISO website abstract purpose is it “provides guidance for organizations in the application of ISO 9001:2000 to the acquisition, supply, development, operation and maintenance of computer software and related support services.” In this standard my understanding is there is an “Acceptance Test” the software development company must perform prior to release in order to conform to ISO/IEC 9003:2004. In addition to above ISO/IEC product, the fifth company will perform their product release using ISO/IEC 25062:2006. According to ISO website, standard method for reporting usability test findings, and thus allowing for users use the usability data to help make informed decisions concerning the release of software products or the procurement of such products.”

In the product realization, each company should test process limits to standards that are regulated by federal, state local laws and or industry code/standards such as American Society of Mechanical Engineering if applicable. For example, a process that has state regulation on water discharge will test their equipment and their process as described in state law. Another regulation would be a car would have to meet car emissions standards. My understanding it would be unlawful for car manufacturer to sell a car that does not reach current emissions standard. Therefore, this car manufacturer would want to test for this regulation prior to sell. My understanding is that are automotive professional standards for automotive engineering such as S.A.E. Handbook by Society of Automotive Engineers. Similar, the fifth company can follow a Software Engineering Standards Institute of Electrical and Electronics Engineers and a IEEE standard for Software Quality Assurance Plans (ANSI/IEEE std 730 1984). The fifth company to conform to quality would also follow IEEE standards because they have software and electronics.

Product Release

Who performs the final product release? (Note: it is usually done by QA). Who issues the Certificate of Analyses or Conformance? What procedures do they / should they follow?

Product release is completed by Quality assurance. Quality assurance would give a certificate of analysis or conformance based on IS0 9000 and equipment or material tested on professional codes or standards.

I briefly discussed this subject matter above in Product Realization section. The fifth company would check their software and electronic equipment to standards such IEEE and that they are in conformance with ISO 9000 requirements. The purpose of the IEEE standard presented is to provide uniform, minimum acceptable requirements for preparation and content of software quality assurance plans. The fifth company would develop their software quality assurance plan according to this standard. Based on this quality assurance I think would be part of the criteria for certificate of analyses of conformance of fifth company’s product.

I could not locate there is regulatory obligation requiring certificate of analyses or conformance is required with product prior to selling. Instead based on my reading of several website, my understanding this is a best practice and certificate of analyses or conformance is given on basis they have met ISO 9000 certification and or followed a professional code and or standard. Therefore, in my opinion the fifth company quality assurance company will perform product release based on ISO 9000 and professional codes and or standards.

Corrective Action/Preventive Action

What procedures do they / should they follow?

The fifth company has established corrective and preventative action procedures to “eliminate the cause of non-conformities and to prevent recurrences, and the fifth company determined actions to eliminate the causes of potential nonconformities in order to prevent occurrence. The fifth company developed their procedures to address above by establishing process model, performing CORA and PFRA analysis on the planning stages. During the operation non conformities were less. However, the fifth companies Corrective Action procedures attempts to address the following questions according to ISO 9000 standard audit evaluation:

“Reviewing nonconformities including customer complaints, and

Determine causes of non conformity, and

Evaluating the need for action to ensure nonconformities do not recur, and

 Determining and implementing action needed.”

Equally as important a documented procedure has been created by the fifth company’s Quality Assurance team to address the following requirements in Preventative Action procedure:

“Determine potential nonconformities and their causes, and

Evaluating the need for action to prevent occurrence of nonconformities,

Determine and implementing actions needed,

Recording and maintain the results of action taken,

Reviewing of preventative action taken.”

Customer Service

Are their customer service staff properly trained to process order and complaints? What procedures do they / should they follow?

Yes the fifth company has a customer service staff properly trained to process orders and complaints. Each staff is trained on a procedure prepared by the fifth company. The level of competency of the employee was determined on that basis the employee was provided the job and training. In addition, customer services representative are monitored for quality purposes. Also, customer service department is survey by their customer to determine customer is meeting the customer quality objectives and areas the customer representative should improve on. By doing so the fifth company is able to monitor and measure effectiveness of the customer service representative. Furthermore, the procedure addresses a methodology for obtaining and using information related to customer perception.

Customer Satisfaction

How do they measure their customer satisfaction? Survey? (What a great opportunity here to use CORA; updated frequently based on market changes...) Complaints? Recalls? What procedures do they / should they follow?

Customer satisfaction is measured using internal and external survey, feedback mechanisms and CORA analysis. Customer perception is monitored by the organization and a development plant to address customer satisfaction is put into affect. CORA analysis is used at the planning stages of each project, product and service. In addition, as the dynamics of the project change CORA analysis is revised and reused in parallel with other tools.

Survey is developed based on the customer service and ISO Standards. Survey items are rated between 1 thru 5, where 5 is the best. Service question items we ask in the survey are: timeliness, did concern get address, resolution satisfaction and would customer recommend this service to someone else.

The fifth company uses ISO standards and has determined methodologies to obtain and use information relating to customer perception. For example, the fifth company uses CORA analysis which has helped reduce customer satisfaction because accurate design specifications have been able to be developed as a result. \

As described in e-learning textbook, four modules are integrated in CORA to obtain customer satisfaction. These modules are the following:

User requirements,

Engineering solutions,

Parameter calculations, and

Benchmarking.

Complaints are addressed by using recorded discussions between the customer representative and the customer. When reviewing tape and addressing the complaint a documented procedure is used to ensure the items that are important to the company have been honored. A document change review is available in case procedures need to be revised.

Recalls? - What procedure do they follow in the case of a recall? What procedures do they / should they follow? (What a great opportunity here to take preventive action to avoid recalls by using PFRA risk analysis!)

Total recalls are address using ISO standards with regarding to quality assurance. The fifth company will subcontract recall processes.

In addition, the fifth company uses PFRA analysis to tools to avoid recall. As indicated in e-learning textbook PFRA analysis is used by a team in the planning stages of a project , product or service. PFRA addresses “negative quality and is primarily concerned with potential events, that can make any process, including service, or even a disassembly process, or the harvested components, fail. PFRA is used by all members of the fifth company and its methodology is part of a procedure that is used at the beginning stages of project, product or service or when there is  a recall to analyze the risks. The PFRA methodology is the following:

• Define scope, function and purpose
• Identify potential risks and failure modes, and their effects
• Prioritize potential failures
• Select and manage subsequent actions
• Observe and learn
• Document the process
• Enter the values into the PFRA / DFRA spreadsheet on a relative scale

PFRA analysis is used for recall prevention and also to identify risks as the projects, product or service are developed, manufactured and sold.

Continuous Improvement: What procedures do they follow? Implementation of standard operating procedures covering the above items and others. Verifying their effectiveness. (Note, that the TQM eBook has an entire Chapter on Continuous Improvement Methods; VERY IMPORTANT in the real-world!)

Continuous improvement is a core value for the fifth company. Furthermore, vendors the fifth company uses also have a continuous improvement process in place, similar to Boeing’s expectation. As described in the E-learning text book, continues improvement is an ISO principle and one that the fifth company follows to obtain an ISO certification. The fifth company’s procedures try to incorporate continuous improvement. This is done in the procedures by “taking into account enterprise-wide needs and be applied in a way that provides consistency and standardization of improvement efforts Ranky).” Company employees are also measured in their performance review for continuous improvement achievement. In addition, the organization, department, sections, and project team are measure in their reviews for evidence of continuous improvement.

Continuous improvement is obtained by continuing six sigma approach and quality system thorugh out the life cycle of the project product or service. Continuous program uses data, measurement, performance indicators to determine areas for improvement. Data collection and factual decision making are also followed as part of the ISO standards and principles. Quality review, auditing, inspections and meeting are all used as part of the continuous improvement program the fifth company implements in every day work.

The fifth company also has standard operating procedures and are periodically reviewed or revised as needed to capture the continuous improvement objectives. The fifth company follow similar approach as the large company like Boieng.. Procedures are in place and these procedures include the following:

“Procedures are needed to make the continuous improvement system a reliable part of the supplier’s processes (Ranky).”

“The procedures should take into account enterprise-wide needs and be applied in a way that provides consistency and standardization of improvement efforts Ranky).”

The fifth company also has top level management expectation to carry and fulfill continuous improvement expectations. The top level management “review continuous improvement activities on a regular basis, cover statistically data review, review performance measures associated with continuous improvement activities, make changes in the performance measures that have been attributed to the continuous improvement projects, and modify as a result of reviewing improvement activities (Ranky).”

Eco-friendliness and carbon footprint audit: Is your company (i.e. the 5th company) an environmentally friendly company? If not, how can you improve to reduce the carbon-footprint?

The fifth company is an eco-friendly Company. The fifth company does not directly produce carbon in their process. However the fifth company does their part with energy and water conservation. Also, the fifth company recycles. The fifth company also allows for work at home and encourage car pool among the employees. Computers are recycled or disposed of properly. The fifth company also has continuous improvement programs by creating awards for ideas to reduce the carbon foot print. This way attention to reduce carbon foot print and have environmental awareness is encouraged.