This is a redacted version of the company's quality management system document.
The unredacted version is maintained by the Quality Manager for staff access only.
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DOC-QMS
Quality Management System
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Latest Revision: L
Revision Date: Jul 15, 2022
This document describes the Quality Management System deployed at Circuit Technology Center. The document addresses the ISO 9001:2015 requirements for a Quality Manual and contains the necessary document procedures.
Circuit Technology Center Quality Policy
- We guarantee full compliance with our services and products by following open and documented procedures and standards with full transparency.
- We strive for the highest level of consistency with our products and services to ensure we delight our customers and meet or exceed their expectations.
- We strive for zero defects and the elimination of waste by constantly looking for opportunities to apply a continuous improvement approach to our business.
- We acknowledge that every team member at all levels of the company is responsible for quality and continuous improvement.
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1.0 Scope
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1.1 General
Circuit Technology Center is the world's largest and most experienced company specializing in repair and rework services for assembled and bare circuit boards. We also offer the CircuitMedic line of high-quality products and supplies to support companies that repair and rework circuit boards in-house. We strive to provide our customers with solutions for all of their circuit board rework and repair needs. We have been offering these services and products since 1983.
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1.2 Commitment to ISO 9001:2015
Circuit Technology Center is committed to the principles and structure of ISO 9001:2015 registration. This quality manual outlines the policies, procedures, and requirements of Circuit Technology Center's Quality Management System.
It applies to all policies, processes, procedures, and records used by Circuit Technology Center to comply with the requirements of the ISO 9001:2015 Standard. The scope includes all products and services provided to customers. Since the Organization does not provide design services to customers at this time, design is not included in the scope.
The control of this document is defined in section 7.5 Documented Information.
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1.3 Revisions
This Quality Management System will be revised as necessary to reflect changes in quality requirements.
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1.4 Management
The management of Circuit Technology Center plays an active role in the development of this Quality Management System and supports the policies described in the manual. All employees play a vital role in maintaining and supporting quality and the Quality Management System.
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1.5 Understanding
The Quality Management System in place at Circuit Technology Center ensures that all employees, temporary employees, and contract employees have an understanding of both the company and customer quality requirements.
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1.6 Records
This Quality Manual, procedures, and work instructions are maintained electronically. All printed copies are for reference only.
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1.7 Feedback
Customers are encouraged to provide feedback at any time about the service, quality, delivery, and performance of Circuit Technology Center services and products. Circuit Technology Center will continue to solicit customer feedback in order to improve the company's performance.
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1.8 System References
The following additional systems and documents are integral to the application of this Quality Management System.
| System |
Location |
| Assembly Instructions - Products |
* Confidential |
| Calibrations System |
* Confidential |
| Discrepant Material Reports |
* Confidential |
| Engineering Change Notices |
* Confidential |
| MRB Corrective and Preventive Actions Reports |
* Confidential |
| Purchase Specifications |
* Confidential |
| Repair/Rework Process Guidelines |
https://www.circuitrework.com/guides/guides.html
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| Training Records |
* Confidential |
* These documents are confidential. Access is restricted.
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2.0 Normative References
The following document, in whole or in part, is normatively referenced in this document and is indispensable for its application.
ISO 9000:2015 Quality Management Systems - Fundamentals and Vocabulary
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3.0 Terms and Definitions
For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.
In addition, this section defines terms that are unique to Circuit Technology Center, Inc.
| Customer Product |
Any type of circuit board assembly, instrument, accessory, tooling, manual, or shipping container that belongs to the customer. |
| Customer Managed Material |
Any type of raw material product supplied to be used in the manufacture, modification, or repair of customer-owned property. |
| MRB |
Refers to Material Review Board. |
| Product |
The end result of meeting all contractual terms and conditions. |
| RMA |
Refers to Return Material Authorization. |
| Revision |
Refers to documented changes. |
| ECN |
Refers to documented Engineering Change Notices. |
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4.0 Context of the Organization
Additional details related to each process are available on the company ISO 9001:2015 QMS Process Clause Matrix.
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4.1 Understanding the Organization and Its Context
4.1.1. At Circuit Technology Center, our mission is to build value for our customers through proven and documented procedures and processes.
4.1.2. Circuit Technology Center is committed to the principles and structure of ISO 9001:2015 and has chosen to use this quality manual as a method to organize policies, procedures, and processes.
4.1.3. Circuit Technology Center reviews external issues by networking with industry peers, attending trade shows, reading industry and business periodicals, and discussions with suppliers and customers.
4.1.4. Circuit Technology Center reviews internal issues by examining MRB reports, management reviews, and listening to employees.
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4.2 Understanding the Needs and Expectations of Interested Parties
The List shown below provides a breakdown of job functions and reporting responsibilities within the Organization. For additional details related to each function, contact Circuit Technology Center, Inc.
President
■ Controller
■ Office Staff
■ Production Manager
■ Technicians
■ CircuitMedic Group
■ Shipping / Receiving
■ Engineering Manager
■ Engineering
■ Quality Control
■ Sales Manager
■ Sales Applications Engineer
■ Customer Support
■ Marketing Manager
Note: The Engineering Manager is also the ISO Management Representative.
Circuit Technology Center shall determine external and internal issues that are relevant to its purpose
and its strategic direction and that affect its ability to achieve the intended results of its quality
management system.
Circuit Technology Center defines interested parties as customers, vendors, employees, governments, and outside auditors.
Circuit Technology Center believes that all employees play a vital role in the quality, service, delivery, and performance of all services and products.
Circuit Technology Center encourages feedback from all interested parties and reviews information relevant to its quality management system from this group of interested parties.
The following core process map shows the significant processes needed for the Quality Management System, their sequence, and their interaction.
Management Core Process Map
Management Processes
■ Management Review
■ Internal Audit
■ Continual Improvement
■ Quality Planning
■ Corrective/Preventive Action
Support Processes
■ Purchasing
■ Training
■ Control of Documents
■ Control of Records
■ Control of Non-conforming Items
■ Control of Measuring Equipment
Repair/Rework Service Core Process Map
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CircuitMedic Product Core Process Map
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4.3 Determining the Scope of the Quality Management System
The Quality Management System at Circuit Technology Center is an integrated set of policies, processes, procedures, and forms that define how the company is managed in order to achieve its quality policy and comply with the requirements of the ISO 9001:2015 Standard.
The primary processes of Circuit Technology Center and references to the associated sub-processes are shown in the core process flow map located in Section 4.2 Understanding the Needs and Expectations of Interested Parties.
Circuit Technology Center's management has established policies and methods to provide for the control of the processes, provide adequate resources, and employ appropriate measures, monitoring, and analysis to maintain an effective Quality Management System and drive continuous improvement. Circuit Technology Center maintains adequate control of the outsourced portion of its processes.
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4.4 Quality Management System and Its Processes
Circuit Technology Center has established, documented, and implemented a Quality Management system in accordance with the requirements of ISO 9001:2015.
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4.4.1 Continuous Quality Improvement
The system is maintained and continually improved through the use of quality objectives, internal and external audit results, analysis of data, corrective and preventative action, and management review.
4.4.1.1. Circuit Technology Center has identified the inputs required and the outputs expected from the process. These are monitored by the use of Key Process Indicators.
4.4.1.2. Circuit Technology Center has identified the sequence and interaction of processes needed for the Quality Management System.
4.4.1.3. Circuit Technology Center has determined the criteria and methods needed to ensure the operation and control of the processes are effective.
4.4.1.4. Circuit Technology Center has secured the continuing availability of resources and information necessary to achieve planned results and for the continual improvement of these processes through annual planning and budgeting processes.
4.4.1.5. Circuit Technology Center has assigned responsibility and authority for these processes.
4.4.1.6. Circuit Technology Center has established systems to evaluate risks and opportunities.
4.4.1.7. Circuit Technology Center has established processes to identify and implement actions necessary to achieve planned results.
4.4.1.8. Circuit Technology Center evaluates results to improve the processes within the Quality Management System.
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4.4.2 Document Maintenance
Circuit Technology Center maintains and retains documented information, work travelers, process flow charts or work instructions to maintain confidence that the processes are being carried out as planned.
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5.0 Leadership
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5.1 Leadership and Commitment
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5.1.1 General
The president and the management team regularly communicate the importance of meeting customer, statutory, and regulatory requirements through personal contact and formal and informal meetings with all employees.
The quality policy and quality objectives are stated elsewhere in this manual.
5.1.1.1. The Management Team has overall responsibility for the Quality Management System. Circuit Technology Center's management team is responsible for implementing, providing resources, reviewing, and maintaining the Quality Management System.
5.1.1.2. Circuit Technology Center's management team is actively involved in establishing the quality policy and quality objectives that parallel Circuit Technology Center's strategic vision and direction.
5.1.1.3. Circuit Technology Center's management team ensures the integration of the Quality Management System in business methods through a process approach and risk-based thinking.
5.1.1.4. To continue to provide leadership, show commitment, and promote the improvement of the Quality Management System, management conducts employee training sessions, management review meetings, customer analysis, and annual budgets for quality-related expenses.
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5.1.2 Customer Focus
The manager of every function within the organization understands how the performance of that function relates to enhancing customer satisfaction. Policies and procedures are in place to ensure customer requirements are understood and met. Frequent contact is maintained with customers to obtain feedback on satisfaction. Customer satisfaction is discussed at staff and employee meetings.
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5.2 Policy
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5.2.1 Establishing the Quality Policy
5.2.1.1. Responsibilities and authorities for personnel at Circuit Technology Center are defined and communicated through the organizational chart, job descriptions, documented procedures, and during yearly personnel performance reviews.
5.2.1.2. The Engineering Manager is the Quality Management System representative. His responsibilities and authorities include ensuring that processes needed for the Quality Management System are established, implemented, and maintained; reporting to top management on the status of the Quality Management System; and ensuring the promotion of awareness of customer requirements throughout the organization.
5.2.1.3. Management maintains daily verbal communication on issues involving customer satisfaction and Quality Management System issues. Periodic management meetings are held to establish formal communication on customer requirements, customer issues, customer changes, production, and/or supplier issues. Management holds meetings with employees at appropriate times to provide awareness of business and customer issues.
5.2.1.4. All employees have been trained in the quality policy, and all new employees are trained at the time of hire. The training is documented in the personnel training records. Copies of the policy are posted at various locations in the facility, on the company website, and noted in company brochures.
5.2.1.5. The understanding of the quality policy is evaluated through frequent contact between management and other personnel and through internal audits. The Quality Policy is reviewed for suitability at least once a year during the management review meeting.
Circuit Technology Center Quality Policy
- We guarantee full compliance with our services and products by following open and documented procedures and standards with full transparency.
- We strive for the highest level of consistency with our products and services to ensure we delight our customers and meet or exceed their expectations.
- We strive for zero defects and the elimination of waste by constantly looking for opportunities to apply a continuous improvement approach to our business.
- We acknowledge that every team member at all levels of the company is responsible for quality and continuous improvement.
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5.2.2 Communicating the Quality Policy
5.2.2.1. Quality objectives are set and reviewed annually in the management review meeting. The objectives are monitored, and corrective actions are initiated during the more frequent management meetings. They include objectives relating to the quality policy, customer satisfaction, and business improvement. Where appropriate, they are established at relevant functions of the organization. A list of the objectives, their measurements, and targets is contained in the management review meeting minutes.
5.2.2.2. The Quality Management System has been planned and is described in this document. The integrity of the Quality Management System is maintained through training and implementation, as applicable, when changes are planned.
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5.3 Organizational Roles, Responsibilities and Authorities
5.3.1. Responsibilities and authorities for personnel at the organization are defined and communicated through the organizational charts, job descriptions, documented procedures, and yearly personnel performance reviews. Job descriptions are available that define the responsibilities and authorities of each of the positions on the organizational chart.
5.3.2. The Organization has appointed the Engineering Manager as the Quality Management System representative. His responsibilities and authorities include: ensuring that processes needed for the Quality Management System are established, implemented, and maintained, reporting to top management on the status of the Quality Management System, and ensuring the promotion of awareness of customer requirements throughout the organization.
5.3.3. Management maintains daily verbal communication on issues involving customer satisfaction and Quality Management System issues. Periodic management meetings are held to establish formal communication on customer requirements, customer issues, customer changes, production, and/or supplier issues. Management holds meetings with employees at appropriate times to provide awareness of business and customer issues.
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6.0 Planning
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6.1 Actions to Address Risks and Opportunities
Circuit Technology Center uses SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis, plus other tools and activities to address risks and opportunities within our organization.
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6.1.1 Quality System Planning
Quality planning is done at the earliest possible stage to ensure Circuit Technology Center's ability to satisfy specified results and requirements. The purpose of the process is to prevent or reduce subpar performance, to enhance the planned outcome, and to achieve improvement in the process, product, or procedure.
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6.1.2 Planning Requirements
Quality planning may take place through contract development, estimating, production review, contract review, and/or order entry. These procedures enable Circuit Technology Center to address risks and opportunities prior to starting production. In addition, these procedures allow Circuit Technology Center to evaluate the effectiveness of the plan and to review the potential impact on Circuit Technology Center's products and services.
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6.2 Quality Objectives and Planning to Achieve Them
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6.2.1 Quality Objectives
Quality Objectives are established to continually improve the Quality Management System as a whole as well as individual management processes or functions. Quality objectives are established, monitored, and reviewed against performance goals during management review meetings.
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6.2.2 Quality Objective Determinations
Circuit Technology Center quality plans are consistent with normal methods of operation covered by existing policies, processes, and procedures. SWOT analysis plus other planning processes are used. These methods detail the quality objectives, resources necessary, responsibilities, timeline, and explain how the results will be measured. These are discussed, assigned, and reviewed during our management review meetings.
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6.3 Planning of Changes
When Circuit Technology Center determines a need to change the Quality Management System, these changes are evaluated by the management team. Several tools are used to assist in the evaluation of the change, including Management Review, Audits, and Quality Management System review. The evaluation process includes a review of the purpose of the change, potential consequences, impact on the Quality Management System, availability of resources, and the assignment/reassignment of responsibilities and authority.
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7.0 Support
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7.1 Resources
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7.1.1 General
Circuit Technology Center has implemented a Quality Management System that complies with the ISO 9001:2015 standards. This implementation was achieved with management commitment and with sufficient resources for implementation. Resources needed to maintain or improve the Quality Management System are identified and appropriated through management review meetings, periodic business meetings, and daily business communications between management and staff, with consideration being given to capabilities and constraints on current resources as well as the needs of Circuit Technology Center's customers and vendors.
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7.1.2 People
The organization shall determine and provide the persons necessary for the effective implementation
of its quality management system and for the operation and control of its processes.
7.1.2.1. Personnel performing activities that either directly or indirectly affect product or service conformity requirements are competent to do so because they possess the appropriate education, training, skills, and/or experience.
7.1.2.2. The organization determines the necessary level of competency for employees who perform work affecting conformity to product or service requirements and provides whatever training is necessary to meet those requirements, including an evaluation of the effectiveness of that training. The evaluation of training effectiveness for management employees is performed by experienced trainers, and records are maintained in an online database.
7.1.2.3. Repair technicians are typically hired based on a combination of education, training, and experience. When appropriate, skill tests are given to confirm the competencies of potential hires. All technicians are provided training as required according to their job classification. They are trained in the various work activities that could be assigned to them by competent employees and/or supervisors. The effectiveness of the training is confirmed through the monitoring of the activities.
7.1.2.4. The organization maintains a computer-based online database to track and record all employee's required competencies and their training status. Recording the completion of training on the database is done after the effectiveness of the training has been confirmed.
7.1.2.5. Non-technician personnel are hired with the competencies required for their respective positions. Their personnel records contain their resumes and other information which details their experience and training.
7.1.2.6. The organization provides specialized training to the general population in areas such as safety, ESD (Electro Static Discharge), hazardous material, and the quality management system. Records of these training activities are filed in the employee's personnel file and in the Training Records system.
7.1.2.7. Once a year, during performance reviews, employees' training and competencies are re-evaluated by their supervisors. Any deficiencies are noted, and training is planned.
7.1.2.8. Refer to the training matrix below for required training according to the organization's job description or classification:
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IPC Standard/Process Related |
Handling/General Safety |
| Job Title |
7711/7721 |
610 |
JSTD |
RoHs |
ReBalling |
PCB |
ESD |
Safety |
| President/CEO |
NR |
NR |
NR |
NR |
NR |
NR |
NR |
NR |
| Controller/CFO |
NR |
NR |
NR |
NR |
NR |
NR |
NR |
NR |
| Engineering Manager |
NR |
NR |
NR |
R |
NR |
R |
R |
R |
| Production Manager |
NR |
NR |
NR |
R |
NR |
R |
R |
R |
| Sales Manager |
NR |
NR |
R |
R |
NR |
R |
R |
R |
| Office Manager |
NR |
NR |
NR |
NR |
NR |
NR |
R |
R |
| Office Assistant |
NR |
NR |
NR |
NR |
NR |
NR |
R |
R |
| Sales Applications Eng. |
NR |
NR |
NR |
R |
NR |
R |
R |
R |
| Product Manager |
NR |
NR |
NR |
R |
NR |
R |
R |
R |
| Product Specialist |
NR |
NR |
NR |
R |
NR |
R |
R |
R |
| Repair Technician |
R |
NR |
R |
R |
NR |
R |
R |
R |
| BGA Technician |
R |
NR |
R |
R |
R |
R |
R |
R |
| Plant Engineer |
R |
NR |
R |
R |
NR |
R |
R |
R |
| QC Inspector |
R |
R |
R |
R |
NR |
R |
R |
R |
| Shipper & Receiver |
NR |
NR |
NR |
NR |
NR |
R |
R |
R |
For the code above R = Required, NR = Not Required
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7.1.3 Infrastructure
The Organization's current building, workspace, equipment, utilities, support services, and working environment have been and will continue to be adequate for the business needs. The Management Team reviews the infrastructure and work environment at appropriate intervals and makes adjustments as necessary.
To satisfy the expectations of our Global Electronics customers, we must maintain proper and acceptable world-class soldering, assembly, and processing techniques. To achieve this goal, the Organization strives to follow and comply with the following three IPC Standards:
IPC-7711C/7721 - Rework, Modification and Repair of Electronic Assemblies
IPC J-STD-001 - Requirement for Soldered Electrical and Electronic Assemblies
IPC-A-610 - Acceptability of Electronic Assemblies
These three IPC Standards are used as our guide for the establishment of an acceptable work environment. The detailed guidelines of these documents are followed and enforced by the company's Management Team on Circuit Technology Center's production floor. For more detailed or specific guidelines, refer to section 4. General Soldering and Assembly Requirements found in IPC J-STD-001 G.
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7.1.4 Environment for the Operation of Processes
A work environment suitable for achieving product conformance is maintained by Circuit Technology Center. Management ensures that the appropriate human and physical factors of the work environment are provided. Consideration of such factors includes health and safety concerns, work methods, handling methods, and working conditions. All employees are encouraged to suggest improvements in the work environment. These improvements are submitted and reviewed on a routine basis.
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7.1.5 Monitoring and Measurement Resources
7.1.5.1 General
In order to ensure the quality and integrity of our services and products, Circuit Technology Center maintains documented procedures necessary to validate the results of our services and products. In addition, Circuit Technology Center maintains evidence of inspection or product compliance
7.1.5.2 Measurement traceability
7.1.5.2.1. Circuit Technology Center has determined the monitoring and measurement to be undertaken, and the monitoring and measuring equipment need to provide controlled processes and provide evidence of conformity of the services performed to customer's requirements.
7.1.5.2.2. The quality manager is responsible for this procedure and for maintaining the calibration system of the measurement device. He is responsible for ensuring the measuring devices have the required capability for the specified applications. The Quality Manager will designate personnel to calibrate tools and gauges used for acceptance inspection or testing. This system shall also include the calibration of all reference standards used.
A list of measuring equipment included in the system is maintained, along with the status of calibration. Technicians and inspectors are responsible for only using measuring devices that are in the calibration system when making conformance measurements. They make sure the devices are within the calibration effective dates and are in good working order. They are to provide clean, safe, and adequate storage for the measuring devices kept in their respective areas
7.1.5.2.3. Unless otherwise required, tools and gauges are calibrated, stored, and used in ambient conditions of temperature and humidity. All calibration and inspection are also to be done in a clean and well-lit area. Should it become necessary to vary from the above ambient conditions during usage, consideration shall be given to measurement accuracy.
7.1.5.2.4. All designated tools and gauges are placed on the database schedule and calibrated at periodic intervals. The intervals shall be established as recommended by the manufacturer, as well as stability, purpose, and degree of usage. The Quality Manager shall review the results of previous calibrations and make changes in the intervals if necessary. They will be shortened or lengthened when the results of previous calibrations provide definite indications that such actions will assure the continued accuracy of the system. A listing of all items to be calibrated and their next calibration will be maintained on the Calibration Record Index so that upcoming calibrations will not be missed.
7.1.5.2.5. For equipment maintained at Circuit Technology Center, written instructions from the equipment manufacturers and/or special written instructions are used for calibration. These instructions can either be located on the Calibration Record, attached to the Record, or contained in equipment manuals. Equipment manuals can be either located in the calibration file or in the equipment. Those performing the in-house calibrations and/or verifications have been trained in these activities. Reference Standards are maintained by an outside calibration service. The outside service has been chosen for its competence to meet all necessary standards, including ISO 9001.
7.1.5.2.6. All calibration shall be supported by individual Calibration Records. The records will be maintained to ensure schedules are followed. The Calibration Record shall include the following:
1. Name and Number
2. History
3. Accuracy
4. Calibration Interval and Due Date
5. Calibration Procedures
6. Latest Calibration Value where applicable
7. Notation of Repair or Adjustment
8. Action is taken if the equipment is found out of calibration
9. Signature
If the measuring and test equipment is found to be out of tolerance, the calibrated equipment will immediately be removed from service. Management will determine if the out-of-tolerance condition is of a magnitude that affects the acceptability of the product. Management will also evaluate the impact of the out-of-tolerance condition by considering the time since the last calibration and the quantity of materials measured. Consideration will be given to corral all in-house materials and re-inspect for suspect conditions, and if the seriousness of the situation warrants, the receivers of suspect materials will be notified and requested to verify the materials and correct discrepancies or return the materials. The results of these evaluations and actions are recorded on the Calibration Record. Copies of Calibration Records are maintained online.
7.1.5.2.7. All applicable measuring, measuring standards, and test equipment shall be labeled to indicate the last calibration date, the next calibration date, and by whom it was calibrated. When labeling is not practical, a coding system shall be used to reflect its status. Measuring equipment not included in the calibration system is labeled as "calibration not required" or "verify before use."
7.1.5.2.8. Many in-house measuring devices are used for reference purposes only and do not require calibration.
7.1.5.2.9. New devices are purchased according to the requirements specified by the quality manager. When possible, new devices are purchased with calibration certificates. The ECN process is employed to introduce the equipment into the calibration system.
7.1.5.2.10. When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application is confirmed by the Quality Manager. This is undertaken prior to use and reconfirmed as necessary.
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7.1.6 Organizational Knowledge
Capturing organizational knowledge is a key to improving performance at Circuit Technology Center. All employees are encouraged to participate in process improvement and documentation processes in order to capture this knowledge and have it added to our formal work instructions and guidelines. The organization uses cross-training and structured training to expand internal knowledge.
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7.2 Competence
Training is an ongoing initiative at Circuit Technology Center. This is done to ensure the competence of employees related to customer requirements and our Quality Management System. Records are kept of employee training. Annual reviews are done to evaluate on-the-job training effectiveness and competency of specific tasks and to review areas for development.
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7.3 Awareness
In order to ensure that employees of Circuit Technology Center are aware of and have access to our Quality Management System, Circuit Technology Center makes the quality policy and manual available on the company's internet site. Other quality objectives are made available to all employees through daily business communications and job packet paperwork. Employees are also provided feedback as to their contribution to the effectiveness of the Quality Management System and what the potential consequences are for not conforming to the Quality Management System requirements. This feedback is provided through daily paperwork, efficiency reports, and results from internal audits.
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7.4 Communication
Circuit Technology Center is proud of its quality management system and, as such, endeavors to communicate with both internal and external interested parties. Internal communications are handled by the management team through daily business communications and employee meetings. Circuit Technology Center provides access to the Quality Manual System documents as appropriate. The company website contains a link to the current ISO registration. All managers or department heads are able to forward Circuit Technology Center's certifications, upon request, from a customer or vendor via daily business communications or via a link from the Circuit Technology Center website.
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7.5 Documented information
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7.5.1 General
This procedure describes the methods used by Circuit Technology Center to review, approve, distribute, and maintain new, revised, or retired controlled documents.
7.5.1.1. The engineering manager is responsible for maintaining the documentation control system, this procedure, and other quality management system documents.
7.5.1.2. Controlled Documents, other than Quality Management System documents, are controlled according to the matrix shown in section 7.5.3.
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7.5.2 Creating and Updating
7.5.2.1. Circuit Technology Center has established the necessary records to provide evidence of conformity to requirements and of the effective operation of the Quality Management System. This section documents the controls needed for the identification, storage, protection, retrieval, retention, and disposition of records.
7.5.2.2. The Quality Manager is responsible for this procedure and its maintenance. The table contained in this section denotes those who are responsible for maintaining the different types of records.
7.5.2.3. Quality records are collected and maintained according to the individual processes and procedures that dictate the generation and collection of the record data.
7.5.2.4. Quality records are identified, indexed, and stored. Retrieval is facilitated by the noted "responsible person." The method of storage prevents record damage and deterioration over a period of time.
7.5.2.5. The "responsible person" is responsible for the purging and the destruction of outdated quality records. Minimum retention times are noted in the table. Records are destroyed either by shredding or deletion, depending on the type of records.
7.5.2.6. Online documents, data, and records are controlled by the president and are continuously backed up in multiple locations.
Control of Records Table
| Record Type |
Location |
Indexing |
Person Responsible |
Retention (min) |
| Management Review Minutes |
Online Database |
Date |
President |
3 yrs |
| Training Records |
Online Database |
Employee Name |
Production Manager |
3 yrs |
Quotes
Review of product requirements |
Enterprise Resource Management System |
Customer Name |
Sales Manager |
10 yrs |
Sales Orders
Review of product requirements |
Enterprise Resource Management System |
Customer Name |
Sales Manager |
10 yrs |
| Calibration Records |
Online Database |
Calibration Due Date |
Engineering Manager |
2 yrs |
| Internal Audit Results |
Online Database |
Date of Audit |
Quality Manager |
2 yrs |
| Non-Conforming Product |
Online Database |
Date/MRB # |
Engineering Manager |
2 yrs |
| Corrective & Preventive Action Results |
Online Database |
Date |
Quality Manager |
2 yrs |
| Inspection and Product Release |
Customer/Job File |
Customer Name |
Sales Manager |
10 yrs |
Purchasing:
Supplier Evaluations, Purchase Orders, Purchase Specs, Incoming Inspection Logs |
Purchasing Files |
Supplier Name |
Product Manager & Office Admin |
3 yrs |
| Process Validations |
N/A |
N/A |
N/A |
N/A |
| Traceability Records |
Customer/Job Files |
Customer Name |
Sales Manager |
10 yrs |
| Customer Property |
Customer/Job Files |
Customer Name |
Sales Manager |
10 yrs |
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7.5.3 Control of Documented Information
The access, storage, and disposition of quality records are documented procedures. Quality Management System records are maintained to demonstrate conformance to requirements, ensure integrity, and provide an audit trail.
7.5.3.1. The Quality Management System is an Engineering Change Notice controlled document. All printed copies are destroyed after each use to ensure only the latest procedure will be followed.
7.5.3.2. The Administration Guide is segmented into the different departments responsible for the activities described. The ownership of the information is distributed to the department managers. The Administration Guide is not a formal Engineering Change Notice controlled document. The controller is responsible for the review and approval of the Administration Guide and other administrative documents and changes to existing administrative documents. Each section is dated, and descriptions of all changes are noted in an appendix attached to the document. The department managers are responsible for training those impacted by changes. All printed copies are destroyed after each use to ensure only the latest procedure will be followed.
7.5.3.3. Repair and Rework procedures for repair and rework of circuit boards primarily follow industry-approved procedures. Some procedures are specific to Circuit Technology Center. All procedures referenced are controlled documents unless otherwise specified. Each Sales Order and related Traveler includes a list of procedures to be followed. The latest procedures are available for operators and technicians for review or printing at appropriate locations.
7.5.3.4. Process Specifications are distinguished from published Repair Procedures. They are either customer-specific procedures or unusual processes that, due to their nature, are not otherwise specified and controlled. The Process Specification system is operated by Engineering. Process Specifications are incorporated into the specification system by Engineering through the release of new specifications or changes to existing specifications. Prior to the release of Process Specifications, a review is made by Quality to ascertain conformity to applicable industry-standard quality provisions. All records are maintained online. All printed copies are destroyed after each use to ensure only the latest procedure will be followed.
7.5.3.5. Travelers are specific work instructions (including workmanship examples) that are distributed to the production floor. The Traveler stays with the product during the repair or rework process. Travelers are not Engineering Change Notice controlled documents but are Revision controlled.
Changes to the Traveler are distributed appropriately by the Sales Application Engineer. All printed copies are filed in the job folders at the completion of the job. Handwritten changes are allowed by the technicians and inspectors but must be initialed and dated by the appropriate sales Application Engineer.
7.5.3.6. Assembly Instructions are used to assemble products for sale in the CircuitMedic division. They are all Engineering Change Notice controlled documents. All printed copies are destroyed after each use to ensure only the latest instruction will be followed.
7.5.3.7. Engineering Change Notice is employed to issue new documents and to control changes to existing documents. The Engineering Change Notice form describes the change being made, the reason for it, and the effect, interchange, and disposition of the parts. The Engineering Change Notice bears the applicable document number, revision letter, and date. All records are maintained online unless otherwise indicated. If paper records are needed, they will be filed in Engineering. Once a specification or document is released, it remains active unless otherwise limited, revised, or made obsolete.
7.5.3.8. Training Guides are used to train employees in the proper techniques of board repair. Unless otherwise specified, they are external documents prepared by Industry Associations.
7.5.3.9. All forms have a specific Form number. Forms are not Engineering Change Notice controlled documents. Each Form is dated, and a description of all changes is noted in the Forms index. The Quality Manager is responsible for training those impacted by changes to forms. No forms are printed in batches and retained in print. Blank forms are printed as needed to ensure only the latest form is used.
7.5.3.10. It is the policy of Circuit Technology Center not to keep copies of reference documents. When the information is needed, it is sourced from the Internet. If there is a need to keep copies of reference documents (such as IPC or ISO documents) the General Manager is responsible for monitoring any changes of the documents, controlling the distribution, and making sure the proper versions are deployed.
7.5.3.11. After the approval process, controlled documents are stored and maintained in a designated folder on the Circuit Technology Center Intranet site. The latest version of the documents is accessible to view as a read-only document or print. Personnel is trained to check for revisions before the use of a printed document. Documents maintained on the company web server are backed up for security.
7.5.3.12. Obsolete documents are generally discarded by the owner of the document. If it is deemed necessary to keep a copy of an obsolete document, the document is marked obsolete and kept in a separate file.
Every document has an identified owner defined by job function. The owner is responsible for generating the document, keeping it current, and updating it to remain in conformance with applicable policies and/or standards.
The document owner shall consult with users, as practical, to ensure document suitability and effectiveness. Document Users are those departments or individuals directly affected or who will be required to follow the requirements in the document on an ongoing basis.
| Type of Document |
Owner |
Location |
| Quality Management System |
Engineering Manager |
Online |
| Administration Guide |
Controller |
Online |
| Repair/Rework Procedures |
Engineering Manager |
Online |
| Process Specifications |
Application Engineers |
Online/Paper |
| Travelers |
Application Engineers |
Online/Paper |
| Assembly Instructions |
Products Manager |
Online/Paper |
| Engineering Change Notices |
Engineering Manager |
Online |
| Training Guides |
Engineering Manager |
Online |
| Forms |
OfficeManager |
Online/Paper |
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8.0 Operation
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8.1 Operational Planning and Control
Product Planning follows the management Core Process Map in section 4.2. The necessary processes, documents, and product-specific resources are set forth in this section of this document.
The required verification, validation, monitoring, inspection, and test activities specific to Circuit Technology Center's products and services and their related records are covered in this document.
Quality planning is done at the earliest possible stage to ensure Circuit Technology Center's ability to satisfy specified requirements. It is Circuit Technology Center's policy to take all necessary measures to ensure customers' requirements can be met and those requirements are communicated effectively throughout the company. Quality planning may take place through contract development, estimating, during contract review, and/or during order entry.
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8.2 Requirements for Products and Services
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8.2.1 Customer Communications
8.2.1.1. The determination of the requirements relating to the product or service is controlled via the Quoting Process and Sales Order Process. The sales manager is responsible for these processes. Pertinent information regarding customers' requirements is recorded in the Quoting Database. During the quoting process, the customer's requirements are reviewed and clarified. The signal of acceptance of a quote is typically a purchase order received from the customer.
Upon receipt of the associated materials for the job, the order is reviewed and modified as needed. The appropriate sales application engineer additionally reviews the sales order for adequacy. Any discrepancies are resolved with the customer by the sales manager. Order acknowledgments are conveyed to the customer via email or verbally to receive customer approval. Records of the review and associated actions are maintained by the sales manager in the system database or in the customer files and result in the sales order status changing from "Pending Approval" to "Pending Fulfillment." The customer's requirements are transferred to a traveler.
The traveler and other pertinent work instructions are provided to the technician selected to complete the work. The final inspector has access to all the pertinent information, including the Sales Order, to ensure
the results meet the customer's requirements.
When product or service requirements change, it is the responsibility of the sales manager or the assigned sales application engineer to ensure all relevant documents are amended and that relevant personnel are made aware of the changed requirements.
8.2.1.2. Customer communication regarding production capabilities, inquiries, order handling, and order amendments are generally coordinated by the Sales Department. Significant customer concerns and issues are
distributed by email to all concerned parties. The Material Review and Corrective Action system is an additional communication device for communicating customer dissatisfaction with Circuit Technology Center's products and services. Employee communication meetings are also employed to disseminate customer feedback.
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8.2.2 Determining the Requirements for Products and Services
During the inquiry, quotation, and order acceptance stages of customer contact, customer service or sales gathers pertinent information related to the customer's requirements and expectations as well as any applicable statutory and regulatory requirements.
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8.2.3 Review of the Requirements for Products and Services
Prior to submission of a quote or acceptance of an order, the Order Entry process requires that a formal review take place to ensure the customer's requirements for the product have been clearly defined and documented and can be met by Circuit Technology Center.
Order reviews occur during the daily production meetings and include:
1. Review of delivery and post-delivery activities.
2. Review of the requirements not stated by the customer when known.
3. Review of the additional requirements by Circuit Technology Center.
4. Review of any statutory or regulatory requirements that are applicable.
5. Review of any contract or order requirements that differ from the customers' requirements or expectations, and if discovered, Circuit Technology Center will notify the customer immediately. Differences are resolved prior to acceptance of the order.
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8.2.4 Changes to Requirements for Products and Services
Change orders are reviewed against the original order. Any changes that require amendments to process or product documentation will result in revising the affected documents and notifying all affected personnel.
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8.3 Design and Development of Products and Services
Not Applicable. Requirements can not be applied. Circuit Technology Center does not provide design services.
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8.3.1 General
Not Applicable. Requirements can not be applied. Circuit Technology Center does not provide design services.
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8.3.2 Design and Development Planning
Not Applicable. Requirements can not be applied. Circuit Technology Center does not provide design services.
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8.3.3 Design and Development Inputs
Not Applicable. Requirements can not be applied. Circuit Technology Center does not provide design services.
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8.3.4 Design and Development Controls
Not Applicable. Requirements can not be applied. Circuit Technology Center does not provide design services.
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8.3.5 Design and Development Outputs
Not Applicable. Requirements can not be applied. Circuit Technology Center does not provide design services.
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8.3.6 Design and Development Changes
Not Applicable. Requirements can not be applied. Circuit Technology Center does not provide design services.
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8.4 Control of Externally Provided Processes, Products and Services
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8.4.1 General
Components, materials, and services that have been purchased from vendors shall conform to specified requirements to ensure appropriate levels of quality, value, and service are received. Quality shall be assured through Vendor Evaluation (both new and existing) that will provide for controlled and effective purchasing activities by Circuit Technology Center's purchasing department. It shall be the responsibility of all qualified purchasing agents to communicate clear, complete purchasing documents, specifications, and drawings to vendors.
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8.4.2 Type and Extent of Control
8.4.2.1. Purpose
This procedure defines the process employed to ensure purchase components, materials, and/or outside services conform to specified requirements and defines the process for selecting suppliers.
8.4.2.2. Scope
This procedure covers items purchased for use in production and items sold included in kits and other products. These goods are considered critical to customer satisfaction.
8.4.2.3. Responsibilities and Authority
The Purchasing Agent or the Engineering Manager is responsible for the purchasing process and this procedure. The Quality Manager provides support to the process.
8.4.2.4. Purchasing Procedure
8.4.2.4.1. Purchase specifications are created for those purchased materials and components considered critical to supporting an acceptable repair process and providing a quality product. The specifications are created by the Quality Manager and are introduced and controlled through the Engineering Change Control process. Customer requirements are taken into consideration when generating the specifications.
8.4.2.4.2. Purchase requisitions are made employing a Purchase Requisition Form.
8.4.2.4.3. Purchase requisitions must be reviewed and approved by the Engineering Manager. The Engineering Manager reviews the requisitions for accuracy and completeness.
8.4.2.4.4. Reviewed and approved requisitions are directed to the Purchasing Agent for processing. Purchase orders are processed employing Circuit Technology Center's Enterprise Resource Management system. Purchasing and Control of Materials are further detailed in the Administration Guide.
8.4.2.4.5. Purchase Orders are generated by the Enterprise Resource Management system. The Purchase Orders adequately describe the product to be purchased, including approval of products, procedures, processes, personnel qualifications, and, if necessary, quality management system requirements. The Purchase Orders are checked for correctness by the Purchasing Agent before they are sent.
8.4.2.4.6. The Enterprise Resource Management system generates a purchasing log that is accessible by the Receiving Agent. The Receiving Agent performs the appropriate inspection of the received goods and provides the necessary records. A discrepant material process is employed if the received goods are found to be non-conforming.
8.4.2.5. Supplier Selection
8.4.2.5.1. Circuit Technology Center purchases its materials either through distribution and/or Original Equipment Manufacturers.
8.4.2.5.2. Distribution suppliers are selected by their access to needed products, reputation, past experience, responsiveness, and competitiveness. Their service performance is monitored. If a distribution supplier is not performing adequately, a re-evaluation is performed.
8.4.2.5.3. Original Equipment Manufacturers' suppliers are chosen for their ability to provide products that meet Circuit Technology Center's requirements and for the quality of their product and service. In some cases, the manufacturer is dictated by the customer. The supplier's performance is monitored and measured. Based upon their performance, re-evaluations are performed.
8.4.2.6. Outside Services
When outside services are employed, Circuit Technology Center ensures adequate control over those processes to ensure the resultant outcome meets all customer and regulatory requirements. As appropriate, the types of controls employed are supplier visits, monitoring the quality of delivered products and/or services, and on-time delivery.
8.4.2.7. Critical Suppliers
Circuit Technology Center identifies and maintains a list of Critical Suppliers. A detailed list of Critical Suppliers can be found in the Administration Guide. At a minimum, the status and performance of each Critical Supplier is reviewed as part of the Management Review Meeting agenda.
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8.4.3 Information for External Providers
Circuit Technology Center ensures the adequacy of the requirements prior to issuing a purchase order for outside materials, components, or processes.
Vendors are provided with all required data that is pertinent to the item or service requested. Information regarding the quality system to be used and/or inspection requirements are clearly defined prior to or at the issuance of the purchase order.
The Quality department, Sales, Engineer, Purchasing Agent, or Customer requirements determine the selection of vendors. The nature and extent of control shall depend on the competency of the authorizing party, the type of product being procured, and the vendor's demonstrated ability to meet all requirements.
When needed, purchasing documents for outside services and products are reviewed by a quality or management representative.
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8.5 Production and Service Provision
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8.5.1 Control of Production and Service Provision
Manufacturing processes are planned and carried out under controlled conditions. The process control procedures are based on the prevention of defects rather than detection based on inspection results. Manufacturing processes are documented, verified, monitored, and audited.
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8.5.2 Identification and Traceability
Procedures are established to provide identification and traceability of the product throughout the production and delivery cycle to ensure conformity to customer, regulatory, and applicable requirements. Components and materials used in manufacturing shall be positively identified by the use of labels or material tags. The process shall determine the extent and scope of inspection required.
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8.5.3 Property Belonging to Customers or External Providers
Vendor or customer-supplied property or material will be handled as mandated by the vendor or customer contract. If the material or property is lost, damaged, or unsuitable for use, the customer service, sales, quality, or purchasing department will initiate contact with the vendor or customer to determine the process for resolution.
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8.5.4 Preservation
Material is protected, identified, and maintained for handling, storage, packaging, and delivery according to documented procedures. All products shall be handled in a manner that provides protection from damage and ensures that customer requirements are satisfied. A final product verification shall be conducted prior to shipping the product to the customer.
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8.5.5 Post-delivery Activities
When performing contract review, Circuit Technology Center evaluates customer, statutory, and regulatory requirements, along with potential issues that may arise from the use of Circuit Technology Center services and products. In order to verify performance, Circuit Technology Center uses several sources to collect data about customer perception as it relates to meeting customer requirements, including on-time delivery, customer retention, customer feedback, and customer warranty claims.
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8.5.6 Control of Changes
In order to avoid unauthorized, unnecessary, or incorrect changes and modifications, as well as to avoid the risk of losing track and control of changes, Circuit Technology Center's policy is to have changes and modifications identified, documented, reviewed, and approved. This is controlled through Travelers, Engineering Change Notices, audit logs, and change orders.
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8.6 Release of Products and Services
Circuit Technology Center has implemented methods for monitoring and measuring characteristics of services and products to verify requirements. These methods are used at appropriate stages of the product realization process. Examples of these processes include work instruction review and release, material verification, quality inspections, and related production and outside service records, packaging, and transportation records. Products are not released to the customer until all planned processes have been satisfactorily completed.
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8.7 Control of Nonconforming Outputs
All employees have the authority to stop any process if non-conformities are detected.
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8.7.1 Nonconforming Outputs
Circuit Technology Center maintains an effective system for controlling nonconforming material through Discrepant Material Reports and a quarantine process. Disposition of nonconforming material and customer contact shall be handled and documented in accordance with this procedure.
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8.7.2 Retaining Information
Discrepant Material Reports and MRB Corrective and Preventive Actions Reports retain information related to any non-conforming product issue, the actions taken, any concessions or agreements with the customer or vendor that have been obtained, and the final action taken with respect to the nonconformity.
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9.0 Performance Evaluation
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9.1 Monitoring, Measurement, Analysis and Evaluation
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9.1.1 General
Statistical techniques and analysis are used throughout the Company as tools for planning, decision-making, and control of processes when required by the customer or application. When contractually required to do so, Quality shall obtain prior approval from the customer for the statistical methods or sampling plan to be used. The use of statistical techniques is not limited to inspection but is used in Engineering and Manufacturing.
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9.1.2 Customer Satisfaction
Due to the size and structure of Circuit Technology Center, there is considerable direct customer interaction between management and Circuit Technology Center's customers. The interaction seeks and reports on the customer's perception as to whether the organization has consistently met the customer's requirements. Informal and management review meetings are employed to review data regarding customer satisfaction and determine what actions may be necessary for improvement. Circuit Technology Center uses various indicators to measure customer satisfaction.
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9.1.2.1 Customer Satisfaction Metrics
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9.1.2.1.1. On-time Delivery
On-time delivery for Circuit Technology Center services and products is a key metric to measure relative to customer satisfaction. On-time delivery is a calculation of the number of orders shipped on time to customers in relation to the total number of orders shipped. Improvements in on-time delivery require optimization of processes across multiple departments in the organization.
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9.1.2.1.2. Customer Returns
The varied processes to repair and rework assembled circuit boards can be extremely challenging, sometimes bordering on impossible. Customer returns will occur when products that do not meet the purchase order requirements or are defective in some way are shipped to a customer. While it is the goal at Circuit Technology Center to drive customer returns to zero, some level is expected. The table below graphs the total number of customer returns by percent over time.
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9.1.2.1.3 Audit Findings
Customer audits present a good opportunity to improve customer satisfaction by examining the findings and implementing improvements. Customer audits are confidential and maintained by the Quality Manager.
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9.1.2.2. Internal Audit
This procedure defines and describes the method for planning and conducting internal audits to verify the implementation, effectiveness, and continued maintenance of the quality management system in accordance with ISO 9001-2015 and the requirements established by Circuit Technology Center. This procedure applies to the preparation, execution, documentation, and follow-up of Circuit Technology Center's internal audit process.
The Quality Systems Manager is responsible for maintaining this procedure and is the owner of the Internal Audit Process.
The Quality Systems Manager has the following responsibilities:
1. Development of the internal audit schedule.
2. Ensures execution of the schedule using qualified independent assessors.
3. Establishes and maintains records of assessments and a log of their status.
4. Review results of corrective actions from all prior assessments.
5. Ensures assessment forms and records are complete, accurate, and current.
All department managers and supervisors have the responsibility to provide staff to help facilitate the process, prepare corrective action plans when necessary, report to the Quality Systems Manager on the progress of implementing such actions, and review the audit schedule for acceptability.
The Quality Systems Manager is responsible for planning, organizing, performing, and reporting the results of the internal audits.
The Quality Systems Manager shall review corrective actions for appropriateness and report to top management on the audit results and significant actions taken.
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9.1.2.3. Procedure/Process
The Quality Systems Manager, with input from management, will create a master audit schedule that shall ensure each activity of the Quality Management System is audited at each relevant location at least once a year. The ISO 9001:2015 Internal Audit Plan form shall be employed to record the audit schedule. The quality manager will review the schedule with management for suitability and approval.
The Quality Systems Manager initiates the internal audits based on the master schedule:
1. Schedule the audit with the manager of the area to be audited.
2. Identifies the audit team, assuring they will be independent in the areas being audited.
Training records of internal auditors will indicate that they are qualified to conduct audits. Internal auditors will be qualified by either attending an Internal Audit seminar or by observing a minimum of 2 audits conducted by a qualified auditor.
Auditors prepare for an audit by familiarizing themselves with the ISO 9001:2015 standard, refreshing their knowledge of the quality and relevant operational procedures, and reviewing corrective and preventive action files. The ISO 9001:2015 Internal Auditor Checklist form will be employed as a guide to address the requirements of the standard and to record compliance. Custom checklists will be employed to address the Quality Management System for specific areas and functions. Attention shall be given to any changes in the system since the last audit to verify that the changes did not negatively affect the quality management system or product and/or process quality.
While conducting the audit, auditors will make use of standard auditing techniques to collect objective evidence and information concerning the subject being audited. Results should be noted on the ISO 9001:2015 Internal Auditor Checklist form with the applicable details, including any documents and records reviewed. Audits shall be conducted along the major processes to make sure the interactions between the processes are effective.
Auditors will keep the department/process manager informed as to the progress of the audit and any findings. All nonconformities are brought to the attention of and discussed with the responsible manager and documented on the ISO 9001:2015 Internal Auditor Checklist form.
At the completion of the audit, the audit team will meet to review the findings and to create an audit summary report. From the summary, an action list will be developed. Corrective and Preventive Actions will be assigned accordingly. The results of the audit and the associated Corrective/Preventive actions will be reviewed at the next Management Review Meeting.
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9.1.2.4. Monitoring and Measurement of Processes
Circuit Technology Center applies suitable methods for monitoring and, where applicable, measurement of the quality management system and other processes important to the profitability of the business. The methods for monitoring and measurement of processes are defined in this document.
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9.1.2.5. Monitoring and Measurement of Product
Circuit Technology Center monitors the characteristics of its products to verify product requirements have been met. The method of verification is planned and defined in the related procedures, appropriate inspection forms, and work instructions. Records are maintained, and the product is released according to the related procedures and work instructions. Products are not released until checked to confirm all the planned inspections and tests have been satisfactorily completed. Records are kept, which include a signed authorization for the release of the products.
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9.1.3 Analysis and Evaluation
Circuit Technology Center has determined, is collecting, and is analyzing appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made.
This data includes data generated as a result of monitoring and measurement and from other relevant sources. Data Circuit Technology Center collects and analyzes on-time delivery, customer complaints, customer returns, and inspection results.
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9.2 Internal Audit
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9.2.1 Internal Audit Planning
Internal audits are planned and performed under controlled conditions to verify Circuit Technology Center's conformance to its Quality Management System requirements as well as the requirements of the ISO 9001:2015 standard. In addition, the internal audits ensure Circuit Technology Center has effectively implemented and maintained its Quality Management System.
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9.2.2 Audit Programming
Circuit Technology Center has established an audit program. The primary tool used to verify requirements is the Internal Quality Audit. The results of internal audits are documented and reviewed with the personnel responsible for the area being audited and during management review meetings.
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9.3 Management Review
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9.3.1 General
9.3.1.1. General
The management team at Circuit Technology Center reviews the various levels of the Quality Management System and company performance in formal and informal meetings.
9.3.1.2. Management Review Meetings
The Annual Management Review Meeting is held to review the Quality Management System to ensure its suitability, adequacy, and effectiveness. The review assesses opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.
The Annual Management Review Meeting employs a set agenda. Meeting minutes are recorded, including decisions made and actions initiated. The review meeting is facilitated, and records are maintained by the management representative. Meetings can be canceled or postponed due to business or personnel availability issues. The Annual Management Review Index is maintained within a separate secure folder.
9.3.1.3. Review Input
The management review includes information on the results of audits, customer feedback, product performance, product conformity, on-time delivery performance, product quality (customer returns), the status of preventive and corrective actions, follow-up actions from previous management reviews, changes that could affect the quality management system, and recommendations for improvement. A review of the status improvement projects and performance to goals and objectives are also addressed.
9.3.1.4. Review Output
The output from the management review includes any decisions and actions related to the improvement of the effectiveness of the quality management system and its processes improvement of the product related to customer requirements and resource needs.
9.3.1.5 Weekly Sales and Management Meetings
Once each week, management meets to review activities that happen on a daily/weekly basis. Each review covers quality issues, scheduling challenges, and manpower management, among other issues.
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9.3.2 Management Review Inputs
Top management shall review the Organization's quality management system at planned intervals to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization. The primary tool used to verify these requirements is the Internal Quality Audit. The results of internal audits are documented, reviewed with the personnel having responsibility in the area being audited and during management review meetings, and archived.
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9.3.3 Management Review Outputs
During the Management review meeting, the management team will identify actions regarding the improvement of the Quality Management System, changes needed in the Quality Management System, and the resources necessary to implement these improvements. These improvements will be documented on a process improvement form or through a management review action item. Management Review Notes are confidential and located in a secure password-protected folder for access by authorized persons only.
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10.0 Improvement
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10.1 General
Circuit Technology Center monitors, measures, analyzes, and improves its processes to demonstrate the conformity of services and products and to ensure they meet stated requirements via the inspection activities noted in the Production process flows and detailed in the travelers. Internal audits, corrective and preventive actions, and management reviews are the main vehicles for driving conformity and improvement of the quality management system.
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10.2 Nonconformity and Corrective Action
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10.2.1 Nonconforming Products and Materials
10.2.1.1. General
Circuit Technology Center ensures that products and materials that do not conform to requirements are identified and controlled to prevent unintended use or delivery. The Quality Manager is responsible for the control of non-conforming products. All employees are responsible for identifying and handling non-conforming products according to this procedure.
10.2.1.2. Incoming Materials - other than customer items sent for repair/rework
If a non-conforming material is found during receiving inspection, a Discrepant Material Report is generated. The report and the material are directed to the Purchasing Agent for handling. The material is held in a designated area until a decision is made to accept it as is, return it to the supplier, or scrap it. If appropriate, corrective action is requested from the supplier. The agent will process a return to the supplier if necessary. Records of the action are noted in the Discrepant Material Database. Materials found defective later in the process follow the same procedure. For major issues, the Sales Manager, Sales Application Engineer, and Quality Manager are notified.
10.2.1.3. Non-conforming Product Found in Process or During Final Inspection
If a non-conformance is found during the final inspection, an MRB record is created in the MRB database. If a non-conforming product is determined to be reworkable by the QC Inspector, the non-conforming product is immediately directed back for rework, the area in question marked on the product. The rework is re-verified to demonstrate conformity to the requirements. The QC Inspector records of the non-conformity, the rework activity, and the re-verification are noted in the MRB database.
If there is a question regarding the suitability for rework or the product was damaged during processing, the product is segregated in a marked Non-conforming product location, and a record is created in the MRB Database. The MRB team, which includes the QC Inspector, Sales Manager, Sales Application Engineer, and Quality Manager, are notified. Depending on the significance of the problem, a meeting could be held, which must include, at a minimum, the QC Inspector plus any one of the other MRB team members to determine what action should be taken. The MRB meeting will result in a decision to either rework, scrap or contact the customer to determine if they can accept the material as is.
In all cases, immediate action is taken to eliminate the cause of the non-conformance, and consideration is given to the Corrective Action Process. In the event of nonconforming products being detected after delivery or use has started, the Quality Manager will evaluate the risk to the customer and take the appropriate action.
All actions are taken, and their results are recorded in the MRB database.
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10.2.2 Document Retention
Circuit Technology Center retains documents associated with the non-conformity and the results of the corrective action.
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10.3 Continual Improvement
Circuit Technology Center continually improves the effectiveness of the Quality Management System through the use of quality objectives, audit results, analysis of data, corrective and preventive actions, SWOT Analysis, and Management Review.
10.3.1. Corrective or Preventive Action Procedure
The purpose of this procedure is to ensure that corrective and/or preventive action is taken to address a problem that has or has the potential to occur.
This procedure applies to an identified process or system non-conformance as well as any problematic performance with respect to internal quality, customer complaints, supplier issues, and/or inconsistencies noted during internal audits of Circuit Technology Center's Quality Management System.
10.3.2. Responsibilities and authority
10.3.2.1. The Quality Manager has the responsibility for the correction and preventive action processes.
10.3.2.2. The management team has the responsibility of reviewing the corrective and preventive system for effectiveness.
10.3.3. Procedure
10.3.3.1. A nonconforming product or service may be identified by any Circuit Technology Center employee. The employee shall inform his supervisor of the issue. The supervisor will determine if corrective action should be considered. If so, he will initiate a Material Review/Corrective Action request. All Material Review/Corrective Action requests are directed to the Quality Manager for processing.
10.3.3.2. The Quality Manager will determine the appropriate tools to detect, analyze, and eliminate causes of non-conformance. The Quality Manager will decide if formal corrective action is required and/or if the management team should be involved. In some cases, a cross-functional team will be created to address the corrective and preventive action.
10.3.3.3. If the problem is process-based, an investigation must be initiated to determine the root cause of non-conformance. After the root cause of actual or potential non-conformance is determined, corrective action may be required, and preventive action must be implemented.
Corrective/ Preventative actions may be requested as a result of, but not limited to:
1. Internal, Quality, or Regulatory audits
2. Employee Input
3. Management Reviews
4. Production Performance Data
5. Customer Complaint
6. Customer Returns
7. Supplier issue(s)
8. Internal non-compliance
9. Preventive action
10.3.3.4. Consideration for taking preventive action can come from trends in performance, minor nonconformities that reoccur, applying corrective actions to other parts of the facility, and using risk analysis methods. The same logs, forms, and process approach as with Corrective Actions are taken for Preventive Actions.
10.3.3.5. Return Material Authorizations are given for all customer returns. A "Vendor Return Form" is employed to keep a record of the return and the processing of credit if necessary. The Engineering Manager makes a determination if a formal correction action is necessary. Corrective action must be performed if required by the customer.
10.3.3.6. If formal corrective action is required, an initial response must be provided to the customer within five business days or less, with a target of ten business days or less for corrective action completion.
1. Once complete, the Quality Manager will verify and assess the effectiveness of actions.
2. Objective evidence of Corrective/Preventive action effectiveness is required for closure. This will be filed with or referenced to on the Material Review/Corrective Action request.
3. If ineffective, the quality manager will direct the person responsible to revise and/or develop a new action plan.
10.3.3.7. Timing and scheduling of follow-up verification are at the discretion of the Quality Manager and vary depending on factors such as:
1. Time is required to generate and gather objective evidence of effectiveness.
2. Critical impact of corrective/preventative action.
3. Available resources.
10.3.3.8. A Corrective and Preventive Action Log is maintained by the Quality Manager and is available to track and verify the status of all Material Review/Corrective Action requests. Copies of the open and closed Material Review/Corrective Action requests are kept online.
10.3.3.9. A summary including the status of all Material Review/Corrective Actions will be included in the management review. Management will review and initiate any action deemed appropriate.
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