NCT management is fully committed to and ultimately responsible for all quality in this company, and NCT employees are fully empowered to assure quality policies are adhered to. The Management Council will set aggressive but achievable Quality Objectives and transmit them to all employees.
Metrics-based continuous improvement will provide the primary influence for all NCT quality activities. Audit findings and quality assurance pickups are systemic "opportunities for improvement" and process issues, not personal failures.
All employees will be encouraged to work as team mates with equal responsibility for the NCT quality system. NCT management shall be accountable and responsive to employee inputs and recommendations.
This policy will be understood, implemented and maintained at all levels of NCT.
4.1.2 Organization
NCT is operated by the President and CEO, who has the ultimate responsibility and authority for managing the QMS. The President and CEO is accountable to the Board of Directors for the quality of all products and all aspects of NCT marketing, designing, manufacturing, distributing and servicing. The Board of Directors is an independent group of three individuals who provide the strategic direction for NCT, and regularly review NCT activities to assure goals are achieved, and that all business practices are consistent with the highest levels of integrity.
4.1.2.1 Responsibility and Authority
The President and CEO shall use the Management Council (MC) as an advisory board for all decisions and directions that have a significant effect on the NCT QMS. MC recommendations will be made by consensus, and final decisions will be made by the President and CEO. The following positions will be filled by competent individuals reporting directly to the President and CEO, and make up the Management Council:
Director of Quality (also Quality Manager): Responsible for establishing, implementing and maintaining the Quality Policy, identifying and recording problems related to NCT products, processes and quality system, initiating action to prevent occurrences and recurrences of product and process nonconformities, recommending, initiating, and providing solutions as required, verifying the effectiveness of solutions and controlling the further processing and deliveries of nonconforming products.
Director of Design and Manufacturing: Responsible for all design and manufacturing of products to meet marketing and service requirements, developing manufacturing processes and techniques, assuring process changes are incorporated in the design and manufacturing processes, assuring all designs and manufacturing processes meet or exceed all statutory and regulatory requirements, and providing a safe and comfortable work environment. Also responsible for all material procurement and scrap/waste disposition in a safe and legal manner.
Director of Sales, Marketing and Distribution: Responsible for assuring all marketing goals are met, delivering all products in a timely and efficient manner, reaching the largest possible customer base for NCT products, making all appropriate contacts with potential customers and finalizing all contracts related to these functions.
Director of Customer Support and Servicing: Responsible for post-delivery product support and customer interface, product warranties and guarantees, tracking and compilation of product integrity issues related to customer satisfaction, product durability, safety and compliance to community requirements, and responsible for providing feedback to NCT that will enable elimination of nonconformities and continuous improvement of product quality, marketability and safety.
All members of the Management Council shall operate to the guiding principal that they are mutually dependent in their functions, and that cooperation and openness are paramount to the success of each individual as well as Northwest Composite Technologies. MC decisions should be reached by consensus but the MC shall vote when a consensus is not achievable. In the rare cases when there is a tie vote, the President and CEO shall cast the last vote. A quorum of the MC is achieved when three members are present.
4.1.2.2 Resources
The President and CEO shall identify resource requirements and provide adequate resources which will include adequately trained personnel for management, work performance and internal audits of the quality system.
4.1.2.3 Management Representative (MR)
The Director of Quality is appointed by the President and CEO to be the Management Representative (MR) of NCT. The MR is responsible for ensuring the quality system is established, implemented and maintained. This person reports directly to the President and CEO in all matters related to the performance of the quality system. The MR is also responsible for liaison with external parties on matters related to the NCT quality system, which includes regulatory and customer contractual requirements.
4.1.2.4 Process Performer - NCT has no such requirements but shall revise this section if necessary
4.1.3 Management Review
The Management Representative shall conduct quarterly reviews of the QMS and all related metrics to assure continuous improvement requirements are met. A report of each review shall be transmitted to the President and CEO, who shall report annually to the Board of Directors. Records of these reviews shall be retained for 4 (four) years.
4.2.1 General Description of the NCT Quality Management System (QMS)
Responsibility: The NCT Management Council is responsible for implementing and managing the QMS for the purpose of ensuring that NCT product conforms to specified requirements. The Director of Quality is responsible for assuring compliance to the standards specified in this manual, all applicable regulatory and environmental requirements, and all standards which NCT chooses to adopt and comply with, including the requirements of AS 9100 and ISO 9000.
4.2.2 Quality System Procedures
The Director of Quality shall assure documents are prepared that are consistent with the requirements of the Quality Manual. The Director of Quality shall also coordinate with all other NCT managers and customers to ensure the NCT QMS is effectively implemented, and conforms to it's documented processes. All processes shall be readily accessible to all personnel who are responsible for performing work in conformance with the processes, and to customers, auditors and regulatory agencies who require access to the documentation. Documented procedures and desktops will be prepared that define how work processes are performed, and they shall make reference to teh Quality Manual as the controlling document.
4.2.3 Quality Planning
The Director of Quality is responsible for defining and documenting how quality system requirements are met. These requirements shall be developed in accordance with the NCT Quality Manual, all relevant regulatory and legal requirements, and AS9100. The Director of Quality shall consider the following when meeting the requirements of the Quality Manual.
Preparation of quality plans
Identification and acquisition of controls, processes, equipment, inspection and test tools and equipment, fixtures, resources and skills that will be needed to achieve the appropriate level of quality.
Assuring compatibility of of design, processes, inspection and test procedures with appropriate documentation.
Updating of quality control, inspection and testing techniques and instrumentation.
Timely identification of any new technology or methods required to achieve the desired level of quality.
Development of in-process verification points as necessary to achieve the desired level of quality.
Clarification of acceptable levels of quality for all products and processes.
Identification, preparation and retention of quality records.
Subcontractor selection (subcontractors shall be audited to the level of quality required by the NCT Quality Manual)
Identification of key characteristics
Identification of materials, processes and services to support manufacturing and servicing of NCT products.
Development of corrective action and follow-up plans to support continuous improvement of NCT and supplier products.
4.2.4 Configuration Management
NCT configuration management shall be maintained for processes by providing all work instructions in READ ONLY electronic format. Any paper documents shall be dated with the following note: "The information in this document, dated mm/dd/yyy, is to be considered accurate only for this date. This document is provided only to represent Northwest Composite Technologies' processes and procedures for audits, regulatory agencies and other requirements".
4.3.1 General
The Director of Sales, Marketing and Distribution is responsible for developing, documenting and managing processes and procedures for reviewing contracts and business proposals as the affect the NCT QMS.
4.3.2 Review
The
In the case of verbal orders, including by telephone, the Director of Sales, Marketing and Distribution is responsible for assuring the order requirements are agreed before acceptance.
The Director of Sales, Marketing and Distribution is responsible for the resolution of differences in the contract
The Director of Sales, Marketing and Distribution is responsible for assuring NCT is able to meet the contract requirements
The Director of Sales, Marketing and Distribution is responsible for evaluating risk associated with a new order or proposal, and the MC members shall assist as requested.
4.3.3 Amendment to a Contract
The Director of Sales, Marketing and Distribution is responsible for review and coordination of all contract or proposal amendments as the affect the NCT QMS. Any necessary coordination shall be conducted in the same manner as a new contract or proposal, detailed above. Minor amendments may be coordinated at a later time, as necessary, but may never adversely affect the quality of the product or the ability of any NCT function to meet requirements.
4.3.4 Records
Records of contracts shall be retained for a minimum of two years after the contract is completed, or longer if made mandatory by contract or by legal or regulatory requirements. The Director of Sales, Marketing and Distribution shall be responsible for retaining records of contract, amended contracts and contract reviews.
4.4.1 General
NCT shall have documented procedures in place to control and verify the design of the product in a manner that will assure the specified requirements are met. The Director of Design and Manufacturing is responsible for the development, implementation and maintenance of these procedures, and shall be responsible for aproval of all design data.
All subcontracted design shall meet the requirements of this Quality Manual. Deviations are acceptable only if approved by the Director of Design and Manufacturing and reported to the Management Council at the next quarterly review.
4.4.2 Design and Development Planning
The Director of Design and Manufacturing is responsible for assuring plans are prepared for each design and development activity. This may be delegated depending on the complexity and criticality of the design and/or plan.
Design activities shall be referenced in the plan, and responsibility for their implementation shall be defined. As the design evolves, the plan shall be updated in a manner that allows all cognizant functions to accommodate changes.
In developing the plan, the following shall be considered:
Organizational requirements
The plan shall be developed in significant elements according to the plan complexity. "Critical path" planning shall be used
Each element shall be analyzed for resource requirements and shall have a person responsible for assuring element completion
Design verification at various stages of the design process (See element 4.4.7, below)
Reliability, maintainability and safety shall be given due consideration for each plan element as required by customer, legal and regulatory requirements. All safety issues that are raised shall be addressed and dispositioned as incorporated elsewhere in existing design, added to design or not required (with reasons to be provided).
4.4.3 Organizational and Technical Interfaces
All interfaces for organizations and technical stakeholders shall be defined in the design process. Necessary information for all interface organizations shall be documented, transmitted and reviewed.
4.4.4 Design Input
All applicable regulatory, statutory and legal requirements shall be identified and incorporated into each design. The Director of Design and Manufacturing is responsible for assuring the design is adequate to meet all such requirements, and shall report to the Management Council (MC) on a quarterly basis through the design and verification process. Any service issues that arise after delivery shall be taken back through the design process for correction, and the Director of Design and Manufacturing shall report those items as well as new designs to the MC.
The design input data shall be defined and documented in terms of functional requirements for production and servicing. Input data shall be developed for each element in the design and development plan.
4.4.5 Design Output
All design outputs shall be compared to design inputs for the purpose of verification and validation. All design outputs shall be reviewed by the Director of Design and Manufacturing before release. The following criteria shall be used to verify that the design output:
Meets design input requirements
Contains or makes reference to acceptance criteria
Identifies those characteristics that are critical to the safe and intended operation of the final product (operating. storage, handling, maintenance, servicing and disposal requirements)
The Director of Design and Manufacturing shall assure all pertinent data are identified before release, that allow identification, manufacture, inspection and servicing of the product. This includes:
Drawings, parts, lists and material & process specifications
A complete list of drawings, part lists, specifications, required to define the configuration and design features of the product.
Information on material, processes, type of manufacture and assembly that will assure conformity of product to design requirements.
The NCT test of completeness for the above might be to simulate sale or licensing of the design to another party for manufacture. Would that other party be able to manufacture the product and meet all requirements without making contact with NCT for clarification or further instructions? The answer to this question must be YES before a design may be released.
4.4.6 Design Review
Formal documented reviews of all designs shall be conducted by the
4.4.7 Design Verification
At various stages in the design process, verification shall be conducted to assure the design meets input requirements. These verification requirements shall be incorporated in the design plan (4.4.2, above). Design verification may include:
Comparison with similar designs
Performing alternate calculations
Conducting tests and demonstrations
Reviewing design stage documents before release
Engaging a consultant or NCT employee not associated with the design to provide a "third set of eyes" to conduct a design review
4.4.8 Design Validation
After design verification (4.4.7 above), design validation shall be conducted to assure the original intent of the design is met, and that it conforms to defined user needs and requirements. The validation shall be performed under controlled conditions, and is normally performed on the final product as a test of manufacturing processes. If there are different intended uses, this may be performed differently for each intended use.
The Director of Design and Manufacturing shall report that the design meets all design and operational requirements, and the product performs as intended under all reasonably foreseen conditions.
Where tests are necessary, the Director of Design and Manufacturing shall assure tests are planned, controlled, reviewed and documented to assure and prove:
Test plans or specifications completely define the product being tested, the intended results of the test(s) and the conditions of testing or demonstration.
Methods of operation, performance and recording of tests are thoroughly detailed in test procedures
Correct configuration standard of the product is presented for the test
The requirements of the test and the test procedures are observed
All acceptance criteria are met
4.4.9 Design Changes
All design changes and modifications shall be identified, documented reviewed and approved by the Director of Design and Manufacturing before being implemented. In all cases, when required, legal, statutory and regulatory requirements shall be met for design changes in a manner that meets the requirements of this section (4.4, Design Control).
The Director of Design and Manufacturing is responsible for establishing and maintaining procedures for controlling all documents and data related to the requirements of this section (4.4, Design Control). This requirement extends to external design and standards as they affect NCT designs. These documents shall meet the requirements of NCT Document and Data Control, Section 4.5.
4.5.1 General
The NCT Director of Quality is responsible for all document and data control, except where otherwise noted. Further, he/she is responsible for maintaining procedures to control all documents and data that relate to the GMS and the Quality Manual. External documents shall be controlled as necessary, including customer documents, standards and regulatory documents. These documents may be in any media, including electronic, paper, microfiche, etc, as the needs of the business dictate.
4.5.2 Document and Data Approval and Issue
The NCT Director of Quality is responsible for developing and coordinating procedures for document and data approval and issue. The manager who is directly responsible for his/her function shall be responsible and have authority for approving and issuing documents and data, but in all cases is responsible for coordination with other affected managers.
NCT document and data control procedures shall be specifically developed with the intent to preclude the inadvertent use of outdated or invalid documents and data. The primary means shall be through configuration management of information, and using "read only" electronic media as the primary means of transmitting information.
Obsolete documents and data shall be retained for two years unless required to be retained longer, for regulatory, legal or other requirements, and they shall be clearly identified as "Superseded", "Replaced" or "Outdated".
When customer furnished data (including digital data) are furnished to NCT, a review of customer requirements shall be conducted to assure NCT processes, policies and procedures are fully capable of meeting the customer's needs.
4.5.3 Document and Data Changes
Changes to documents or data shall be reviewed by the same organizations or functions that performed the original reviews and approvals. Deviations from this requirement shall be approved by the Director of Quality, and all deviations shall be reviewed by the Management Council on a quarterly basis. When changes are submitted for review and approval, the reviewing functions/organizations shall have access to the background information needed to conduct their reviews.
Where appropriate, all changed documents shall identify the nature of changes, in order to facilitate review and incorporation into existing procedures. NCT shall retain a permanent record of changes, and shall coordinate changes with external organizations as necessary, including customers and regulatory agencies.
A documented process shall be developed which ensures timely review, distribution and incorporation of all reviewed and approved drawings, standards, specifications, planning and changes.
4.6.1 General
The Director of Design and Manufacturing shall be responsible for all aspects of purchasing, except where specifically reassigned by the Management Council (MC). The Director of Design and Manufacturing is responsible for developing and maintaining documented procedures to assure supplier quality. All purchased product shall conform to specified requirements, which shall be transmitted to the suppliers. The Director of Design and Manufacturing is responsible for the quality of all purchased products.
4.6.2 Evaluation of Subcontractors
The Director of Design and Manufacturing is responsible for assuring that the quality of all purchased products meet minimum quality requirements, including customer requirements. The Director of Quality shall assist where needed, such as supplier audits and supplier performance metrics. Further:
Suppliers shall be evaluated, selected and retained based on their ability to meet minimum QMS requirements.
All supplier performance shall be controlled to a level consistent with the criticality of their products to the quality of the NCT products.
Subcontractor assessment records shall be retained by the Director of Design and Manufacturing, and accessible to all members of the MC and appropriate regulatory agencies.
All suppliers shall use NCT approved subcontractors and suppliers, or shall use selection criteria acceptable to NCT.
The Director of Design and Manufacturing shall have authority to take corrective action when a supplier deviated from acceptable criteria, and he/she shall have the authority to disapprove a supplier for cause
The Director of Design and Manufacturing shall periodically review supplier performance with the Director of Quality. These reviews shall occur at least twice annually.
The Director of Design and Manufacturing shall develop and maintain procedures that detail actions to take when a supplier's performance is unsatisfactory or falls below minimum requirements.
The Director of Design and Manufacturing is responsible for maintaining a list of approved suppliers and their approval status.
4.6.3 Purchasing Data
Purchasing documents shall clearly describe the ordered product, including:
Specific information related to type, class or grade of ordered product, consistent with it's intended use.
Specific information related to technical data, specifications, drawings, process requirements and inspection criteria, including information related to approval or qualification of the product.
Identification of the quality system standard to be applied, which is the NCT QMS or a commonly accepted standard.
Design, test or inspection requirements, and any other related requirements.
Access to the supplier's facilities and quality records by NCT or any properly approved customer or regulatory agency.
Requirements for test specimens or coupons, and related data that will allow traceabiity of those specimens to their source, to allow audits and service difficulty investigations
Requirements that will allow NCT to be informed of anomolies, design changes and process changes.
NCT customers may review NCT purchasing data as necessary
4.6.4 Verification of Purchased Product
All purchased product shall be verified in a manner consistent with it's criticality to the quality of NCT final products. The Director of Design and Manufacturing is responsible for verification of purchased product, and shall develop and maintain procedures to assure verification. The Dorector of Quality shall assist as necessary. Verification of purchased product may be accomplished by any combination of the following:
Obtaining objective evidence from suppliers and/or subcontractors such as test reports, certificates of conformity, etc.
Inspection and audits at the source (Note: In this case, purchasing documents and/or contracts shall specify the type of verification that is to be conducted, in order to assure access)
Documentation reviews
Receiving inspection consistent with the criticality of received material to NCT final products
Delegation to the subcontractor or supplier, with a means to assure continued delegation is warranted (NOte: A list of delegated organizations and their status shall be maintained)
In cases which require that a customer of NCT or an authorized regulator must have access to a supplier's facilities, such access requirements shall be stated in the contract agreement or purchase documents. NCT shall not consider such access to be equivalent to or replacement for NCT's verification procedures, and NCT verification of purchased product shall not be affected by such access EXCEPT - audit and surveillance data legitimately provided to NCT by a third party may be utilized in determining the need for additional supplier surveillance.
4.7 Control of Customer-Supplied Product
NCT shall maintain, handle, store and dispose of customer-supplied product in a manner that meets all customer requirements. Any such product that is lost, damaged or otherwise unsuitable for use shall be reported to the supplier. The Director of Quality shall assure all NCT processes are compatible with customer quality requirements, and when not, shall assure processes and facilities are developed that accommodate the differences.
4.8 Product Identification and Traceability
All NCT products shall have:
Permanent marks OR
Permanently molded numbers/verbage OR
Permanently affixed data plates,
for all products that are required to have such identification.
In all cases when a serial number is required to allow traceability back through the entire procurement and manufacturing processes, serial numbers shall be included with product marking.
If required by law or regulation, NCT records shall provide for:
Retention of all required product identification through the product life
Traceability of all NCT products to their original material batches
Identification of assembly components and next higher assemblies
Sequential records of products
Identification of NCT actual and intended (design) product configuration
4.9.1 General
The NCT Director of Quality has responsibility for establishing procedures to control NCT procedures, and to assure coordination with Management Council (MC) members. The Director of Quality is responsible for assuring each MC member is aware of his/her responsibilities as they relate to the identification and planning of production, installation and servicing processes as they affect quality, and for carrying out the processes under appropriately controlled conditions, which include:
Procedures in the Quality Manual and all subordinate documents and processes
A suitable working environment (lighting, temperature, cleanliness, etc)
Compliance with regulations, laws, codes and quality requirements
Monitoring of key characteristics as required to meet quality and other requirements
Approval of new and revised processes and equipment
Specifications for workmanship and finish as described in procedures and desktop instructions
A maintenance plan and equipment to assure continuous capability as it affects quality
Accountability and tracing of all product during manufacture, including nonconformities
Evidence that all required procedures are completed during manufacture, or that deviations are reviewed, approved and recorded as necessary
Assuring that all material is free from foreign material or objects that affect product quality
Availability of utilities and supplies (power, air, chemicals, water, etc) as required for quality
4.9.1.1 Production Documentation
All production data will be approved by the Director of Design and Manufacturing or his/her delegate (Note: a delegate must have a Letter of Delegation from the Director of Design and Manufacturing on file). Minor deviations are allowed, but must be clearly defined, and shall be recorded for later review. Production data shall include:
Drawings, parts lists and process flow charts
Production documents, manufacturing plans, work orders and process cards
A list of required tools required to complete a process
All documentation required for the proper use, maintenance and calibration (if required) of tools
4.9.1.2 Control of Production Process Changes
Persons required to approve process changes shall be approved by the Director of Quality or the Director of Design and Manufacturing, and letters of approval shall be retained in their personnel files.
If customer approval is required for any changes, those processes shall be clearly identified as such
All changes to processes, tools and equipment shall be assessed to determine if any other processes, tools and equipment are adversely affected
All changes affecting processes, equipment and tools shall be documented
4.9.1.3 Control of Production Equipment, Tools and Numerical Control (NC) Machine Programs
All production equipment and tools shall be evaluated and approved prior to incorporation within the NCT processes, including NC machines and programs. In all cases, equipment and tools shall be maintained as required in order to assure they continue to function as intended. A first article inspection shall be conducted for each article produced, tested or otherwise affected by new equipment or tools.
4.9.1.4 Control of Work Performed Outside of NCT Facilities
Any supplier who performs work outside NCT facilities shall be audited and approved by the Director of Quality for compliance with all NCT quality requirements. All deviations must be recorded accommodated.
4.9.2 Special Processes
All special processes shall be identified, and processes shall be developed and maintained in a manner that assures the products meet their intended design requirements. For this purpose, a special process is defined as a process that may not be easily inspected after the fact, or when process deficiencies may be discovered only in use. For composite products such as those which NCT manufactures, it may be appropriate to manufacture a sample "coupon" for each layup, and conduct a destructive test of each coupon as a representative part of a final assembly. Records of all special processes and tests will be retained as required for quality, regulatory and legal purposes.
Special processes shall be identified and tested before use
Special processes shall be controlled as necessary in order to achieve the desired product quality, with emphasis on operations and parameters that are considered to be significant
4.10.1 General
The NCT Director of Quality establishes and maintains documented procedures for inspection and testing activities intended to verify that product requirements are met. The Director of Quality is also responsible for determining appropriate record keeping requirements for both types of records and duration of retention. Resources and methods to be implemented include:
Authorized personnel
Limits of authorization
Training and qualification requirements
Inspection documentation shall include:
Acceptance and rejection criteria
Where inspections & tests must be conducted in the manufacturing processes
Recording of inspection results
Identification of production inspection instruments
Documents associated with the design, maintenance and validation (calibration) of instruments
All subcontracted inspection and tests shall remain the responsibility of the NCT Director of Quality, with no change to the above requirements.
4.10.2 Receiving Inspection and Testing
All received products and materials shall be prevented from use until they have been inspected or otherwise shown to be acceptable for use in NCT production in accordance with documented procedures. For certain standard parts and materials, and for suppliers with a statistically high level of receiving acceptance, receiving inspection may be waived in lieu of a documented and statistically validated sampling program. Consideration shall also be given to the level of control exercised at the supplier's premises.
If incoming products or material must be placed in production before inspection at receiving, accurate records shall be maintained which will facilitate recall and replacement if they fail to conform to production requirements. A procedure such as this shall be referred to as "positive recall", shall be properly documented and subject to audit.
When a supplier's validation tests are used to accept products or materials, those tests shall be verified by supplier audits or by a sampling technique that meets production requirements.
4.10.3 In-Process Inspection and Testing
All NCT products shall be subject to in-process inspection and tests only when specified by design and acceptance requirements, or as required by the quality plan.
In all cases, in-process inspection shall be conducted when required, and all product shall be held until in-process inspections and tests can be conducted. The only exceptions to this are the positive recall procedures authorized in 4.10.2 above.
4.10.4 Final Inspection and Testing
All NCT product shall be subject to final inspection and testing for conformance to design requirements. The only exception is products that have been specifically designated with the statement "Final Inspection and/or Testing Not Required", or an equivalent statement. This exception shall be used only in rare instances, and shall be reported, with justification, to the Management Council in their quarterly review.
No NCT product shall be released, sold or transferred until it has been shown by test or inspection to have passed all design, process and conformance requirements, except those that meet the exception above.
4.10.5 Inspection and Test Records
NCT shall retain all inspection and test records that demonstrate all required inspections and tests have been conducted. These records shall clearly show that product has passed or failed according to defined acceptance criteria. See Section 4.13.2 for requirements for handling and disposition of nonconforming product.
When required by design criteria, actual test data shall be retained for not less than 2 years or longer as required by design, legal or regulatory criteria.
4.10.6 First Article Inspection (FAI)
For all production articles there shall be a process in place for inspection, verification and documentation of first production articles. FAI documentation shall be retained and shall include a list of the characteristics required by the design, including tolerances. FAI shall be updated to incorporate significant design, process or production changes. Minor changes shall be subject to FAI when the cumulative effect may become significant.
This requirement shall not apply to specialty or "one of a kind" products but in all cases those types of products shall be reported to the Director of Quality as "Non FAI Products"..
4.11Control of Inspection, Measuring and Test Equipment
4.11.1 General
The Director of Quality shall be responsible for establishing and maintaining documented procedures to control, calibrate and maintain inspection, measuring and test equipment (including measuring devices) and software if they are used to show conformance to NCT specified requirements. In all cases, measurement uncertainty shall be known and shall be consistent with the required measuring capability. This includes devices, software and processes supplied by NCT customers.
Test software or comparative references shall be checked regularly as recommended by supplier, but no less than twice annually. Records shall be retained as long as NCT products may reasonably expect to be in service, and shall be made available to customers, customers representatives, or regulatory agencies as required.
Inspection, test or measuring equipment includes all types of devices used by any supplier or contractor, and also includes personally owned devices used for product acceptance.
4.11.2 Control Procedure
The Director of Quality and Director of Design and Manufacturing shall:
Determine all measurements to be made and accuracy required
Identify all inspection, measuring and test equipment that can affect product quality, and develop and implement processes to assure all such equipment is calibrated and adjusted at appropriate intervals. The Director of Quality shall keep a current list of this equipment, including customer supplied equipment
Define calibration processes, including acceptance criteria and action to be taken when results are not satisfactory
Develop a means to demonstrate or otherwise show calibration status of all equipment required to be calibrated
Maintain records of calibration histories
develop a means of determining calibration history of all equipment found to be out of calibration, to assure equipment was functioning properly before calibration failure. All product found to be nonconforming as a result of a calibration error must be dispositioned
Ensure environmental conditions allow equipment to remain within calibration limits
Assure handling, storage and preservation of equipment does not negatively affect calibration
Assure inspection, measuring and test facilities are safeguarded from adjustments which may invalidate calibrations
Define the method of recall for equipment that must be recalibrated.
4.12 Inspection and Test Status
General
The inspection and test status of NCT products shall be identified by a suitable means, and the conformance or nonconformance of NCT products shall be indicated with regard to inspections and tests performed. The identification of inspection or test status shall be maintained throughout the production, installation, delivery and service lives of NCT products, for the purpose of ensuring that only product which has passed required inspections is used, dispatched, delivered or installed.
4.12.1 Authorized Signatories
The NCT Director of Quality shall maintain records which identify personnel who are authorized to verify, certify and release products. These records shall be made available to any person or organization who is authorized to view them for contractual, legal or regulatory purposes. The records of authorized signatories shall be maintained as long as the inspection and test status records are retained (See 4.12 General, above).
4.12.2 Acceptance Authority Media
For NCT purposes, Acceptance Authority Media are defined as stamps, electronic passwords or electronic or actual signatures which are used to indicate acceptance of products or processes. These Acceptance Authority media shall be suitably controlled by the NCT Director of Quality and shall be kept up to date. Any person who leaves NCT employment or takes a new position that precludes the use of Acceptance Authority Media shall no longer be authorized to approve products or processes, and that person shall be removed from the list of authorized persons.
4.13 Control of Nonconforming Product
4.13.1 General
All nonconforming product shall be identified by a suitable means and segregated from all other product, and shall be prevented from entering service, or unintended use or installation.
The controls that shall be used shall provide for identification, evaluation, segregation (when practical) and disposition of nonconforming product. All functions and areas, both internal and external, that are affected by such nonconformities shall be notified, including suppliers, customers and regulatory agencies as required. This shall include process and procedural nonconformities as they affect product quality. All delivered products that are found to have nonconformities shall be subject to these requirements, whether returned by a customer or still in the field.
4.13.2 Review and Disposition of Nonconforming Product
All nonconforming product shall be examined by the individuals or organizations with design and manufacturing authority, and who have been authorized by the Management Council. The final disposition may be one of the following:
Use as is
Repair Repaired product must be re-inspected.
Rework to original requirements Reworked product must be re-inspected.
Re-graded for alternative applications. In this case the product shall be identified as re-graded, and adequate test reports and certifications shall reflect the re-grading.
Scrap or reject. Such parts shall immediately be permanently marked or positively controlled until physically rendered unusable.
When required by contract, any changes to nonconforming product shall be reported for concession to the customer. The customer shall be provided adequate information to allow a clear understanding of the nature of the disposition. In all cases above, disposition of nonconforming material may be subject to contractual or regulatory requirements, which must be considered.
In cases of nonconforming product that has been delivered and is in use, NCT shall assure timely notification is made to all customers and regulatory organizations in a manner consistent with product safety, warranty and regulatory requirements. Notifications shall include adequate information to allow rapid identification of nonconforming products and removal from service when warranted. Such information shall include part numbers, serial numbers, quantity and dates of manufacture and delivery.
4.14 Corrective and Preventive Action, and Continuous Improvement
Note: Continuous Improvement is not required by AS9100 as of the date of this publication, but AS9100-2000 and the related ISO Standards will require it, AND it is the right thing to do, so it was added here.
4.14.1 General
The Director of Quality shall be responsible for developing and implementing documented procedures for corrective and preventive action. All members of the Management Council are responsible for implementing those procedures within their areas of responsibility, as well as seeking opportunities for continuous improvement.
All corrective and preventive action shall be consistent with the magnitude of the problems and commensurate with the risks encountered. "Risks" shall be identified as they affect workplace, customer and public safety, noncompliance with laws and regulations, and NCT business viability.
All changes to documented procedures as a result of corrective and preventive actions shall be incorporated into the affected documents.
4.14.2 Corrective Action
Procedures for corrective action and shall include:
Effective handling of customer complaints and reports of nonconformities
Investigation of root cause(s) to prevent recurrence and enable improvement
Determination of corrective action needed to prevent recurrences
Application of controls to ensure corective action is taken
Flowdown of corrective action to suppliers and subcontractors
Actions necessary when corrective or preventive action are not achieved
Records of corrective and preventive action
4.14.3 Preventive Action
Procedures for preventive action shall include
Use of appropriate information sources including but not limited to: audit results, quality records, service reports, and customer complaints to detect, analyze and eliminate potential causes of nonconformities
Determination of the steps necessary to incorporate preventive action
initiation of preventive action and application of controls to assure viability
Ensure the Management Council is briefed quarterly on all preventive action
Quality records that reflect preventive action
4.14.4 Continuous Improvement
Procedures for continuous improvement shall include
Using data from all reasonable sources such as employee suggestions, customer complaints, audit results, regulatory inputs, customer comments and suggestions and industry trends
Review of existing processes and procedures during activities such as design control, management reviews, quality planning, and manufacturing and inspection
Training of all NCT employees in methods and techniques of Continuous Improvement
Encouraging subcontractors and suppliers to engage in continuous improvement activities
4.15 Handling, Storage, Packaging, Preservation and Delivery
4.15.1 General
The Director of Design and Manufacturing shall be responsible for developing procedures for handling, storage, packaging, preservation and delivery of product. Consideration shall be given, at a minimum, to employee, public and customer safety, regulatory, statutory and legal requirements and business needs of NCT. These procedures shall include:
Cleaning
Prevention, detection and removal of foreign objects and material
Special handling for sensitive products (including temperature and humidity requirements)
Marking and labeling including safety requirements
Shelf life control and stock rotation (especially critical for composite meaterials)
HAZMAT (Hazardous materials)
4.15.2 Handling
Handling procedures shall be developed that prevent damage or deterioration
4.15.3 Storage
Designated storage areas shall be used and controlled in a manner that shall prevent damage or deterioration of product. Appropriate methods shall be used to move product or remove it from storage, including authorizations. All material that is subject to deterioration shall be inspected at appropriate intervals that will preclude the use of such materials in production.
4.15.4 Packaging
All packing, packaging and marking shall be controlled in a manner that ensures conformance to specified requirements. This shall apply in all cases of receiving, storage, internal movement and shipping.
4.15.5 Preservation
NCT shall develop and apply proper methods of preservation and segregation of product as required, when those products are under NCT control.
4.15.6 Delivery
The Director of Sales, Marketing and Distribution shall be responsible for ensuring that all shipped product is protected and conforms to requirements after final inspection and test. This requirement shall be extended to final delivery at the intended destination, and customers requirements shall also be complied with.
The Director of Sales, Marketing and Distribution is responsible for ensuring that all required documents accompany shipped products, and are present at delivery as required in contracts and/or orders. Such documentation shall be protected from loss, damage and deterioration.
4.16 Control of Quality Records
The NCT Quality Manager is responsible for assuring that all quality records are identified, collected, controlled, and retained and retrievable in a manner that meets all legal, regulatory and contractual requirements. All records shall be disposed of as appropriate, and shall be retained for a minimum of two years with the exception of records specifically identified as requiring longer retention. Records may be archived but in every case shall be retrievable within 3 (three) working days of a demand. Processes shall be maintained for identification, collection, indexing, access, filing, storage, maintenance, and disposition of quality records.
Quality records shall be maintained to demonstrate conformance to specific design and manufacturing requirements and the effectiveness of the quality system. These records shall include subcontractor records as they affect the NCT quality system. Quality records shall be available for regulatory review when requested, and for customer review when required by contract.
Quality records shall be legible and shall be retained in a place and manner that prevents damage or deterioration and that prevents loss. NCT shall retain records in an electronic format whenever feasible, with appropriate redundant data backups which shall be physically separated from the original quality records. In some cases, paper records are necessary, and shall be retained as appropriate.
The NCT Quality Manager plans and conducts periodic internal audits for the purpose of verifying quality effectiveness and the ability of quality activities to comply with the intent of the QMS. Internal audits are scheduled on the basis of the status and importance of the processes and activities being audited, and shall be conducted by appropriately trained personnel who are not directly involved in the subject processes or activities. The Quality Manager may choose to utilize an outside auditor when warranted. The Management Council (MC )shall review the NCT audit program quarterly, and the President and CEO shall receive an annual briefing from the MC.
Detailed audit tools and techniques shall be developed, including checksheets, process flowcharts or other appropriate tools to support audits of the procedural requirements. The effectiveness of the tools shall be evaluated against the overall NCT performance and the ability of NCT to develop corrective action and measure process improvement.
The results of all audits shall be recorded and presented to the person(s) responsible for the area audited. The manager responsible for the area being audited shall take corrective and preventive action, shall explore the audit data for process improvement opportunities and shall, where practical, develop metrics for tracking corrective actions and process improvements. Follow up activities shall be conducted to identify trends and to verify and record the effectiveness of corrective action.
Responsibility: The NCT Quality Manager identifies and documents the quality skills required of all NCT personnel performing activities affecting quality, assures appropriate training is developed or procured, and that necessary records are retained as mandated by all legal and regulatory requirements. Training shall be intended to provide an awareness and understanding of relevant NCT procedures and instructions.
Training procedures shall cover the following at a minimum:
Identify training needs for personnel performing activities that affect quality
Identify training requirements for personnel performing tasks related to regulatory or legal requirements or affecting parts and documentation conformity
Maintaining training records and determining recurring training requirements
Development and regular review of training requirements for personnel who must be qualified based on appropriate education, training and experience. It is to be noted that many NCT skills are learned in the "on the job" (OJT) training.
Training topics shall include at a minimum:
Workplace safety and hazardous material
NCT quality management philosophy and techniques
The NCT Management Council ensures there is an active and effective servicing program. Documented procedures shall be maintained for performing, verifying and reporting that servicing meets customer needs and all appropriate warranty, legal, and regulatory requirements. The Director of Design and Manufacturing is accountable to the MC for customer satisfaction and legal/regulatory compliance as they relate to servicing. The servicing program shall include at a minimum:
A means for NCT customers to contact the Director of Design and Manufacturing
A reporting system as required to meet legal and regulatory requirements
A feedback process to enable continuous improvement, including the control and updating of technical documentation
A method of collecting and analyzing in-service data
Processes and actions to be taken when problems are identified after delivery
Approval, control and use of repair documentation and processes, including controls required for off-site work.
Introduction: The NCT Quality Manager is responsible for establishing and maintaining procedures as necessary to evaluate, control and verify process effectiveness and improvement.
4.20.1 Identification of Need
The Director of Quality shall work closely with the Director of Design and Manufacturing to identify the need for statistical techniques required for establishing, controlling and verifying process capability and product characteristics. All statistical techniques shall be recorded and regularly evaluated for effectiveness, validity and appropriate use.
4.20.2 Procedures
The Director of Quality and Director of Design and Manufacturing shall use statistical process control techniques to:
Track and analyze performance in the areas of supplier performance, NCT design, manufacturing and servicing
Track and manage process control in selection and inspection of key characteristics, process capability measurements, statistical process control and design of test and experiment
Determine required improvement activities
Failure mode and effect analysis (FMEA)
Conduct design verification
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Copyright © 2000-2012 Borfitz.com Enterprises Inc
This Quality Manual may not be reproduced in whole or in part without the express
written permission of Borfitz.com Enterprises, Seattle, WA
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