22.8 Measurement, Analysis, and Improvement


22.8 Measurement, Analysis, and Improvement

8.1: General

Monitoring and Measuring As part of the program to continually improve GCQMS effectiveness, an extensive program in monitoring and measuring, such as inspection and testing protocols at Growth, are created, controlled, and recorded by quality assurance and include reliability testing at accelerated temperatures over extended test times. The director of quality assurance is responsible for all inspection and test procedures at Growth. The primary document for this activity is contained in the procedure entitled "Inspection and Testing Processes." landT.Doc

Analytical Methods Sampling techniques for incoming raw materials are performed by quality assurance against historically based sampling plans that include 100% sampling. Key materials such as printed circuit boards and other integrated circuits are either pretested before receipt or received with certificates of compliance. The rejection rate on some material (e.g., cables) is historically minimal, and a dock to stock process is used.

Growth uses data analysis and graphical techniques, such as Pareto charts, to study both the results of corrective and preventive action and the results of reliability testing and nonconforming product behavior. A limited program in statistical process control (SPC) is also in use, and, if successful, will be expanded at the discretion of the vice president of manufacturing.

In the case of software analysis, field feedback and failure data is collected and maintained by the vice president of quality assurance in conjunction with the software design manager for review and prioritization by the program managers and the customer service manager.

Procedure The document that describes Growth's statistical techniques is contained in the procedure entitled "Data and Statistical Analysis Processes." StatTech.Doc

Yield Analysis Production records the results on a board-by-board basis of first pass testing. The results are archived in an Excel database and used to plot a first pass yield. Analysis of yield information is the responsibility of the director of quality assurance. Yields.Doc

8.2: Monitoring and measurement

8.2.1: Customer Satisfaction

As discussed previously in Section 5.2 of this manual, the vice president of sales and marketing is responsible for customer satisfaction management. The method used to determine and enhance customer satisfaction and determine and minimize customer dissatisfaction includes customer surveys, customer service feedback, and feedback from the sales offices in the form of weekly reports.

This theme is further developed in Section 5.4.1, where we discuss the sales and marketing quality objectives in which customer satisfaction is highlighted. Additionally, repeat business is seriously considered to determine our customer's perception of Growth's quality performance. Some of the larger OEM customers send periodic reports that stipulate quality indexes against which we have successfully performed.

8.2.2: Internal Audit

Procedures Growth's procedure for internal quality audits is entitled quality audit processes. All audit protocols are managed by the director of quality assurance. Audits.Doc

The document details the following:

  • Selection, training, and proficiency requirements of internal quality auditors;

  • Way in which auditor independence is ensured by the controller;

  • Gathering of specific information concerning the area to be audited by the auditors;

  • Use of the auditor's checklist that is an Integrated ISO 9001 and ISO 9000-3 Standard and Software Guideline, respectively;

  • Observance and testing of quality documentation and quality activities;

  • Documentation of corrective actions for any noncompliances found by means of a corrective action report (CAR);

  • Publication of the audit report;

  • Follow-up by the lead auditor(s) to ensure the corrective actions have been completed and are effective in achieving the quality goals and objectives of Growth.

  • The management of customer, vendor, and third-party audits.

Schedules The schedule of internal quality audits is determined by the vice president of quality assurance. For this purpose, an annual timeline is published, as all areas of the company are audited on an annual basis against the appropriate element(s) of the integrated standard.

The frequency of areas audited is based on their recent performance, CAR history, and the importance of that area within the quality system.

Records The results of the internal quality audits, recorded on internal quality reports by the auditors, are maintained by the vice president of quality assurance.

Corrective Action The corrective action items documented during the internal quality audits are reviewed by the auditor with the assigned company employee directly responsible for the quality activity. Mutually satisfactory date(s) are set for completion of the noted corrective actions.

Follow up The follow-up audits are conducted on the scheduled date(s) for completion of either action items or corrective actions. The results are presented by the auditor to the employees directly responsible for the quality activities audited.

Closure The action items or corrective actions are closed when the auditor determines that the actions taken are effective. This process may require several iterations.

Presentation The vice president of quality assurance presents, by exception, the status of the internal quality audits at the management review meetings.

Escalation A corrective action not completed according to plan is escalated to the president through the management review meetings.

Supplier Audits The vice president of quality assurance is also responsible for the management of key supplier audits. The key suppliers include assembly houses for outsourced builds, printed circuit board vendors, cable manufacturers, and memory SIMM module supplier. Supplier CARs (SCARs) are issued if required to the supplier for corrective and preventive action.

Critical Production Audit Areas A comprehensive set of procedures is in place to ensure that all customer and supplier material is properly safeguarded from electrostatic discharge throughout the manufacturing process flow. These include electrostatic awareness training, wrist, heel strap, and conductive floor wax monitoring, and grounding of floor and bench top mats.

A work instruction is used to measure and record solder paste deposition data for sample quantities of all jobs requiring the solder paste screen print process. A work instruction is also used to ensure that printed circuit boards meet or exceed customer or Growth cleanliness requirements. An omega meter is used to set up and audit the circuit board cleaning process on a daily basis.

Training All auditors receive internal quality audit training provided by the vice president of quality assurance. Additional external training is encouraged and sponsored by Growth.

8.2.3: Monitoring and Measurement of Processes

Audits As described in Section 8.2.2 of this manual, Growth performs an extensive first- and second-party audit program to make sure that Growth processes are efficient and effective. Growth also includes third-party and customer audit results into its strategic planning cycle.

Process Analytics Section 8.1 of this manual describes the way in which Growth uses analytical techniques to evaluate the effectiveness of its processes. The evaluations are based on an intensive set of quality objectives described in Section 5.4.1 of this manual.

Corrective Action As described in Section 8.5 of this manual, Growth employs an extensive system of corrective and preventive action, which includes a significant customer complaint response program, to investigate and resolve process-related issues.

8.2.4: Monitoring and Measurement of Product

Growth monitoring and measurement of product includes not only the incoming inspection and testing process discussed in Section 7.4 of this manual, but an extensive program of in-process and final inspection and testing of product. The vice president of quality assurance is responsible for all inspection and test procedures at Growth (refer to Inspection and Testing Processes). IandT.Doc

In Process Each key step of in-process inspection and testing is monitored by quality-control personnel. Specific check points include the following:

  • First article: A first article inspection process performed on the first board of every production run. A distinct work tag is attached to identify that assembly. Authorization to commence the production run is given when the board passes this procedure.

  • Prereflow: A prereflow solder inspection is performed on 100% of boards requiring the reflow soldering process. This inspection is performed immediately after the pick-and-place process by manufacturing personnel.

  • Component side: A top-side in-process inspection is performed on 100% of boards built on either the prototype or production lines.

  • Prewave: A prewave solder in-process inspection is performed on 100% of the boards requiring the wave solder process.

  • Bottom side: When applicable, a bottom-side inspection is performed on boards built on either the prototype or production lines. This inspection is performed by quality-control personnel.

  • Special in-process tests: Various types of electrical, functional, or visual testing is performed on a board at particular process locations as required. This testing either conforms to customer requirements or is deemed appropriate to ensure conformity to customer or Growth quality standards.

Final Inspection A final inspection is performed on 100% of boards built on either the prototype or production lines. All final inspections are performed by quality-control personnel. Finally assembled products are visually inspected by operators to verify that the products have the appropriate stamps or tags. Product that undergoes functional tests and burn-in are logged into the first pass yield database for analysis. All inspected and tested product receive a stamp to indicate completeness.

Records and Nonconformances Any material or assembly found in nonconformance is promptly identified and segregated as such. Prompt action is then taken to bring the material back into conformance or disposition according to the protocols for the control of nonconforming product as discussed in Section 8.3 of this manual.

The records of acceptance and/or rejection, which clearly show the responsible inspection authority, are maintained in their respective areas (i.e., either in materials or quality-assurance files).

Notification of products on hold is identified by a QC verbal communication to all affected areas. Any changes required to remove the product from hold is done through the ECO process.

All product that is shipped from Growth meets all required specifications. The shipper is required to verify the inclusion of all product and related components into the shipped package, including software and documentation as noted on the pick ticket for the order. The shipper validates the pick ticket with date shipped and his or her initials.

Software For required software, the software files to be replicated are revision controlled by means of the ECO process and its associated part number. Error checking is built into the replication process.

Records All records are maintained by either quality assurance or materials, as appropriate.

Customer Validation When required by contract, final acceptance occurs in the engineering validation phase, whereby the customer either attends the final testing or the testing is done at the customer's site, and the customer accepts or rejects the product's performance.

8.3: Control of Nonconforming Product

Process The process by which Growth identifies, documents, evaluates, separates, and disposes of nonconforming product, and notifies the appropriate executive functions, is contained within the document entitled "Control of Nonconforming Process." NCProcess.Doc

An MRB is used to make nonconforming product and material decisions. The group is represented by quality assurance, manufacturing, and continuing engineering, and the MRB report is used to notify the affected areas.

MRB Options Dispositions include rework, acceptance with or without repair by concession, and swap/replacement.

Concessions Concessions are achieved through direct contact between Growth's sales and marketing department and the customer.

Rework If a product fails in test and can be reworked, it is retested and reinspected. Products that cannot be reworked are tagged and segregated for further disposition by the MRB. For example, rejected products are identified and segregated from conforming product into one of three areas (i.e., the rework area on the manufacturing floor, the works in progress shortage rack on the manufacturing floor or the nonconformance storage cabinet in the stock room).

Failed Parts Other products, such as SIMM modules, cable assemblies, and components that fail in the process or in the field are dispositioned by segregating the material into an MRB location. Purchasing notifies the appropriate vendor for a return authorization number and returns the material to the vendor.

Records If agreed contractually, where nonconforming product is used as a result of concession with either the customer or the customer's representative, the nature of the nonconformity and the method of repair is recorded and reported to the customer. Sales and marketing handles this interface.

Reinspection In all cases, repaired and or reworked product is reinspected prior to shipment. When necessary, specific rework work instructions are used.

After-Sales Protocols Growth's after-sales process is described in Section 7.5.1 of this manual. After-sales activities are primarily the customer service manager's responsibility. Field data is key to the evaluation of product quality and reliability and is a bell weather for customer satisfaction or dissatisfaction.

8.4: Analysis of Data

Growth has described its extensive program to determine, collect, and analyze data, as a way to demonstrate the suitability and effectiveness of the GCQMS, in a number of sections in this manual. This information has been shown to be a key evaluation tool to establish where continual improvement of GCQMS effectiveness has occurred. In summary:

  • Customer satisfaction is addressed in Section 8.2.1 of this manual.

  • Conformity to product requirements is addressed in Section 7.2.1 of this manual.

  • Trend analysis is addressed in Section 8.1 if this manual.

  • Preventive action is address in Section 8.5.3 of this manual.

  • The evaluation of suppliers is addressed in Section 7.4 of this manual.

In all cases, the evaluations are based on clearly described quality objectives, metrics, and targets, as addressed in Section 5.4.1 of this manual.

8.5: Improvement

8.5.1: Continual Improvement

Growth's vigorous and intensive program to continually improve GCQMS effectiveness is primarily based on the following inputs:

  • Quality policy (see Section 5.3 of this manual);

  • Quality objectives (see Section 5.4.1 of this manual);

  • Audit results as a result of first-, second-, and third-party assessments (see Section 8.2.2 of this manual);

  • Analysis of data (see Section 8.4 of this manual);

  • Corrective and preventive actions (see Sections 8.5.2 and 8.5.3 of this manual);

  • Management review by the GEMT (see Section 5.6 of this manual).

8.5.2: Corrective Action

Procedure The document describing corrective and preventive action is entitled "Corrective and Preventive Action Processes with Customer Complaints." CAPA.Doc

This process of analysis includes the following programs:

  • Audit program;

  • Customer complaints;

  • Customer returns;

  • Product issue reports, which include software and hardware issues, and product feature requests;

  • Customer/field reports;

  • Engineering and documentation change control;

  • First pass yield and quality data overview.

These areas form the data input for the corrective and preventative action program.

Responsibility The management of this program and the analysis of this data is the joint responsibility of the GEMT. The chairman of the group is the vice president of quality assurance.

Level of Action The level of corrective and/or preventive actions taken by Growth depends on its degree of impact on the product lines. These decisions are made by the GEMT. The GEMT can also assign decision making to local area managers, as required. Another way of resolving specific critical issues is by the formation of an engineering and support crash team when needed under the management of the vice president of design engineering.

Revisions The corrective and preventive action program uses the document and data control process to provide a means to change any documentation required as a result of this process.

In-Plant Operations In-plant operations include all in-plant inspection and acceptance testing, as well as the RMA system. All nonconformances are identified, corrected, and verified at Growth.

This data is contained in databases. These databases are managed by quality-assurance staff, who review and analyze the information. The vice president of quality-assurance reports these findings and the status of subsequent corrective action requests to top management in the management review meetings.

Handling CARs When a corrective action request is presented to a local area manager, it is the local area manager's responsibility to take timely action in defining and eliminating the root cause of the nonconformance.

Verification The presenter of the CAR is responsible for ensuring that the corrective action is taken and that it was effective, so that effective closure can occur.

Audit Program The vice president of quality assurance is responsible for managing the total quality audit program. This program includes: internal audits, SCARS, third-party audits, and customer audits. The status of this program is presented at the management review meetings.

Subcontractor Verification Corrective actions that result from subcontractor evaluation from results of incoming inspection, such as return to vendor (RTV) items, final test, or from on-site inspection, are managed by the vice president of quality assurance with the assistance of the purchasing manager.

Product Development Verification Corrective actions that result from engineering activities, which include the hardware and software databases, are the responsibility of the vice president of design engineering.

Managers All managers are responsible for the detection, analysis, and the eventual elimination of potential causes of nonconformities through the examination of available data. This data includes returned material, customer complaints, discrepant material reports, design review, and current documentation.

Plan All managers are responsible for generating the plan to remove potential causes of the nonconformity and for ensuring the plan results in the effective control of such actions.

Action All managers are responsible for collection and analysis of data within their respective areas. From the analysis of this data, the managers are responsible for deciding the appropriate action to be taken. These actions can include formation of quality improvement teams, assignment of tasks, and issuance of ECOS.

Customer Complaints

Responsibility: The customer service manager is responsible for collecting, analyzing, and generating corrective actions related to customer complaints. The customer complaints are obtained through the following sources:

  • Direct customer contact via phone, fax, or e-mail;

  • Field sales representatives or distributors.

Resolution: The corrective and preventive action programs are used to resolve customer complaints. Resolution is generally through the customer service complaints logs and the SCAR/CAR databases. Any form of customer feedback that is received can result in a CAR. As a result, this policy is designed to service the needs of the customer, yet minimize the burden placed upon the customer due to procedural requirements.

Status: The vice president of sales and marketing presents the status of customer complaints at the management review meetings.

8.5.3: Preventive Action

In addition to the general statements in regard to corrective and preventive action addressed in Section 8.5.2 of this manual, we note a few more specific activities related to preventive action at Growth.

Reporting The vice president of quality assurance coordinates the reporting at the management review on the status of any action plans that are taken in the area of preventive action.

Data Analysis For this purpose, data is analyzed from manufacturing, sales and marketing, quality assurance, and design engineering to detect and eliminate potential causes of nonconformities. Such data is displayed as Pareto charts on a monthly basis and reported as part of the management review process. A list of preventive actions is maintained to indicate progress in this important area.

Preventive actions are formed from all administrative and operational areas (e.g., improvements in the use of people, machines, instrumentation, facilities, and test procedures).

As with corrective actions, the scope of consideration, cost, and time spent in the resolution of preventive-action-related issues are proportional to the impact of such issues on the economic status of Growth. We do not wish to spend a million dollars to solve a one dollar problem. The GEMT is charged with this part of decision making. Records are maintained by the vice president of quality assurance for all corrective and preventive action activities.




ISO 9001(c) 2000 Quality Management System Design
ISO 9001: 2000 Quality Management System Design
ISBN: 1580535267
EAN: 2147483647
Year: 2003
Pages: 155

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