|
1.1 Scope
The most current edition of the International Standard ISO9001:2008 will govern Microspace Instruments Inc. quality business system. Requiring the quality management system to demonstrate its ability to consistently
provide services that meet customer orders and contracts, applicable statutory and regulatory requirements applicable to the product, and efforts for continual improvement of the system and the assurance of conformity to
customer requirements. This manual and all other Microspace Instruments Inc. quality management documentation are proprietary. All unauthorized use is prohibited.
The Organization will align its systems to support the
precision machining and housing industry to the process-oriented methodology to focus on importance of processes producing the desired outcome. The process-oriented audit approach will include the review, identification, and
management of linked activities by examining the ongoing controls over the linkage between the individual processes within the system as well as their combination and interaction in meeting the requirements of the International
Technical Specification. Objective evidence will be demonstrated between the business systems and process links identified in the Management Systems Manual InPuts and OutPuts and the Work Instructions provided for Operations.
1.2 Application
Exclusion(s):
MII is a speciality manufacturing service provider and is not design responsible.
Section 7.3 Design and Development and the Musical Instruments Business Sector will be an exclusion of the ISO 9001:2008 Standard. All other requirements of the international standard ISO9001:2008 are applicable. Site-specific functions occur cross functionally through sound business systems. MII applies this quality management system to supplies, materials and services procured as well as to products produced and/or services rendered for MII customers.
This Quality Manual applies to all activities and personnel associated with the processes depicted in the Process Interaction Diagram to ensure products meet customer and applicable staturatory and regulatory
requirements. Microspace Instruments Inc (MII) specializes in precision machining and housings providing services like CNC, conventional, and microscopic machining for materials used in engineering design and mil-spec
painting. MII supports aerospace, medical, and serves as a fast industry resource precision machining and tooling.
MII, a speciality precision machining and fabrication shop, serves as a support to pro-type and
build for product design manufacturing engineers in creating and solving those "impossible" parts.
The speciality market niche that defines the success of MII, is its capabilities that extend from supporting inhouse fabricatation of sample parts from preparing support fixtures before fabrication of First Article Inspection to a total machining and fabrication system supporting the aerospace, defense, and medical industries. MII provides feedback upon request or under the prints of contract provided by the customer.
1.3 Procedures
Written procedures for supplementing the system described herein have been established and are maintained.
Sections Level II and Level III documents are not included in this Quality Manual, but are referenced throughout Section 4.0 of this manual.
1.4 Corporate Statements
Vision, Mission, and Quality Statements
Vision Statement
Microspace Instruments Inc. will be the prime source for precision machining and fabrication.
Mission Statement
Microspace Instruments Inc. is committed to earn the relationship as the development
partner of choice for precision machining and fabrication.
Through the use of precision and micro-precision machining equipment, our employees are dedicated resources and committed to continuously improve our product technological services in order to fully satisfy our internal and external customers' needs and expectations providing innovative, timely and cost effective solutions, we will meet our objectives and growth in sales and earnings.
Quality Statement
Microspace Instruments Inc. employees recognize that quality is a key strategic issue in the achievement of our business goals and objectives.
We are committed to the principles of continuous improvement in quality, productivity, cost, technology and delivery in order to provide our customers with world-class quality products and services. We will utilize cross-functional teams, statistical tools, and advanced quality planning techniques, and clearly defined procedures and work instructions as the primary methodologies for achieving continuous improvement. Every employee in our business is involved in this task.
1.5 Management Principles:
Microspace Instruments Inc. management system embraces the Eight Management Principles that are referenced from ISO 9000:2008 Quality Management Systems – Fundamentals and Vocabulary. Departmental managers are to ensure
these principles are demonstrated and cascaded through the Organization.
Principle 1 – Customer Focus: We are dependent on our customers and therefore should understand our current and future customers' needs. We will
meet our customers' requirements and strive to exceed their expectations.
Principle 2 – Leadership: Our management team will establish our purpose and direction for the Organization. They will create and maintain an
internal environment in which our people can become fully involved in achieving our organization's objectives.
Principle 3 – Involvement of People: Our people at all levels of the Organization are the essence of our
success in meeting customer requirements. Their involvement will enable our organization to benefit from their activities.
Principle 4 – Process Approach: A desired result is achieved more efficiently when our activities
and related resources are managed as a process approach, giving us an efficient desired result.
Principle 5 – System Approach to Management: Our systems approach to management will identify and insure understanding in
managing our interrelated processes as a system contributing to the Organization's effectiveness and efficiency in achieving our objectives for quality.
Principle 6 – Continual Improvement: Continual improvement of the
Organization's overall performance is a permanent objective of our organization.
Principle 7 – Factual Approach to Decision Making: We will analyze our data and information to make effective decisions.
Principle 8
– Mutually Beneficial Supplier Relationship: We believe that our suppliers and ourselves are interdependent and that a mutually beneficial relationship will enhance the ability of both of us to create value.
1.6 Company Profile
Microspace Instruments Inc. is a privately owned company established in 1957. MII has been a preferred supplier to high-technology companies since 1966 satisfying the critical needs of High-Technology industries such as
aerospace, defense, electronics, geophysics, and medical equipment.
MII has the reputation and capabilities to perform those tough job other sites turn aside with a "No Bid" stamp. Our close association with key aerospace and defense contractors has enabled us to develop unique capabilities in special product areas in machine housing, carrier plates, and hardware for microwave circuitry, edge lighted knobs, radar screens overlays, and flow microfilm cameras for geophysical and oceanographic.
MII offers a wide range of specialized and general machining capabilities such as conventional machining, grinding, engraving, CNC Milling and engraving, swiss automatic and multiple turret lathe work, mechanical and
electro mechanical assembly, precision soldering on materials such as moly, kovar, stainless steel, titanium, macor, teflon, beryllium, copper, as well as conventional copper, brass and carbon steel. We distinguish ourselves
from our competition by offering microscopic machining and microscopic center less grinding along with our full range of production services.
1.7 Microspace Instruments Inc. Process Interactions
2.0 Normative References
Normative document ISO9000:2008 Quality Management Systems – Fundamentals and vocabulary most recent edition is encouraged to be used for guidelines.
3.0 Terms and Definitions
The terms and definitions given in ISO9000 and ISO 9001 apply to the Technical Specification.
Terms relating to the supply chain have been changed accordingly. The term "organization" replaces the term "supplier" and the term "supplier" replaces "subcontractor". Additional terms and definitions given in ISO 9001:2008 are identified in the glossary section.
4.0 Quality Management System
4.1 General Requirements
The Organization has established, documented and implemented a quality management system in accordance with the requirements of the ISO9001:2008 Technical Specification and is committed to maintaining and continually improving
the effectiveness of this quality system. The Organization has:
a) determine the processes needed for the quality management system and their application throughout the Organization
b) determined the sequences and interaction of these processes,
c) determined the criteria and methods needed to ensure the operation and controls of these processes are effective,
d) ensured the availability of resources
and information necessary to support the operation and monitoring of processes
e) monitors, measures where applicable and analyzes these processes, and
f) implemented action necessary to achieve planned results and
continual improvement of these processes.
The Organization will manage these processes in accordance with the requirements of the ISO9001:2008 Technical Specification.
Where the Organization chooses to
outsource any process that affects product conformity to requirements, these processes will be controlled identified within the quality management system. The type and nature of controls applied to the outsourced processes may
be influenced by the potential impact of the outsourced processes capable of conforming to requirements, the extent to control shared processes, and capability of achieving necessary controls through the applications.
In any manner, outsourced processes do not absolve the Organization of the responsibility of conformity to all customer, statutory, and regulatory requirements.
NOTE: Processes needed for the quality management
system referred to above include processes for management activities, provision of resources, product realization and measurement, analysis and improvement, outsourced processes and nature of controls applying to outsourced
processes.
4.2 Documentation Requirements
4.2.1 General
The quality management system documentation includes:
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures and records required by the ISO9001:2008
Technical Specification,
d) documents and records needed to ensure the effective planning, operation and control of its processes, and
e) records required by the ISO9001:2008 Technical Specification.
The
quality system documentation is structured as follows:
Level 1 – Policies, Quality Manual, Quality Policy Level 2 – Procedures supporting Process Interactions and Support Processes; Level 3 - Work Instructions; and Level 4 – Records. Documents written may include the requirements of one or more procedures and the requirements of one procedure may be covered by more than one document.
4.2.2 Quality Manual
The Organization has established and maintains this quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions,
b) reference to the documented
procedures established for the quality management system, and
c) a description of the interaction between the processes of the quality management system.
4.2.3 Control of Documents
Documents required by the quality management system are controlled. Documented procedures are established to define the controls needed to:
a) approve documents for adequacy prior to issue,
b) review and update as necessary and re-approve documents,
c) ensure that changes and the current revision status of documents are identified,
d) ensure that relevant versions of applicable documents are available
at points of use,
e) ensure that documents remain legible and readily identifiable,
f) ensure that documents of external origin determined by the Organization necessary for the planning and operation in the QMS are
identified and their distribution controlled, and
g) prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
4.2.4 Control of Records
Records are established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system are controlled.
Records are legible, readily identifiable and retrievable. A documented procedure is established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of quality records. The control of records satisfies regulatory and customer requirements.
5.0 Management Responsibility
5.1 Management Commitment
Senior management provides evidence of its commitment to the development and improvement of the quality management system and to continually improving its effectiveness by
a) communicating to the Organization the importance
of meeting customer as well as statutory and regulatory requirements
b) establishing the quality policy,
c) ensuring that quality objectives are established,
d) conducting management reviews,
e) ensuring the availability of resources.
5.2 Customer Focus
Senior management ensures that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).
5.3 Quality Policy
Senior Management ensures that the quality policy:
a) is appropriate to the purpose of the Organization,
b) includes a commitment to comply with requirements and to continually improve the effectiveness of the quality
management system,
c) provides a framework for establishing and reviewing quality objectives,
d) is communicated and understood within the Organization, and
e) is reviewed for continuing suitability.
5.4 Planning
5.4.1 Quality Objectives
Senior Management ensures that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the Organization. The quality objectives are
measurable, consistent with the quality policy, and included in the business plan.
5.4.2 Quality Management System Planning
Senior management ensures that
a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and
b) that the integrity of the quality
management system is maintained when changes to the quality management system are planned and implemented.
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority
Senior Management ensures that responsibilities and authorities are defined and communicated. Senior Management has designated resources with the responsibility and authority for corrective and preventive actions of
quality problems and are promptly notified of products or processes that do not conform to requirements.
Operations personnel are in charge of and responsible for ensuring product quality is maintained and Senior Management has authorized them to correct quality problems.
5.5.2 Management Representative
The President has appointed the VP Quality, irrespective of other responsibilities, has responsibility and authority for:
a) ensuring that processes needed for the quality management system are established implemented and
maintained,
b) reporting to Senior management on the performance of the quality management system and any need for improvement,
c) ensuring the promotion of awareness of customer requirements throughout The Organization,
(NOTE: The responsibility of a management representative must be a member of the Organization's own management and can include a liaison with external parties on matters relating to the quality management system.) and
d)
maintaining liaison with external parties on matters relating to the quality management system.
5.5.3 Internal Communication
Senior management ensures that appropriate communication processes are established within the Organization and that communication takes place regarding the effectiveness of the quality management system.
5.6 Management Review
5.6.1 General
The President has appointed the VP Operations, VP Finance, and VP Quality Management Representative the responsibility for reviewing the quality management system at planned intervals, to ensure its continuing suitability,
adequacy and effectiveness.
This review includes assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records from management reviews are maintained (see 4.2.4).
5.6 2 Review Input
The input to management review includes information on
a) results of audits,
b) customer feedback,
c) process performance and product conformity,
d) status of preventive and corrective actions,
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system,
g) recommendations for improvement.
5.6.3 Review Output
The output from the management review includes any decisions and actions related to
a) improvement of the effectiveness of the quality management system and its processes,
b) improvement of product related to customer requirements, and
c) resource needs.
6.0 Resource Management
6.1 Provision of Resources
The Organization determines and provides the resources needed
a) to implement and maintain the quality management system and continually improve its effectiveness, and
b) to enhance customer satisfaction by meeting customer requirements.
6.2 Human Resources
6.2.1 General
The VP Operations is responsible for ensuring personnel performing any task within the QMS that may directly or indirectly affect conformity to product requirements are competent based on appropriate education, training, skills
and experience.
6.2.2 Competence, Awareness and Training
The Organization's VP Operation's has responsibility for:
a) determining the necessary competence for personnel performing work affecting conformity to product requirements,
b) where applicable, providing training or takes
other actions to achieve necessary competence,
c) ensure that the necessary competence has been achieved,
d) requiring assurance that the necessary competence has been achieved,
e) ensuring that, and measures the
extent to which, its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives and
f) maintaining appropriate records of education, training,
skills and experience (see 4.2.4).
6.3 Infrastructure
The Organization determines, provides and maintains the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable
a) buildings, workspace and associated utilities,
b)
process equipment (both hardware and software), information systems, and
c) supporting services (such as transport, communication or other information systems).
The Organization uses a multidisciplinary approach for
developing plant, facility and equipment plans. A contingency plan has been prepared to satisfy customer requirements in the event of an emergency. Work environment relates to conditions under which work is
performed including physical, environmental and other factors such as noise, temperature, humidity, lighting, or weather. This activity is part of the cross-functional advanced quality planning process and annual
budgeting process performed by the Vice Presidents.
6.4 Work Environment
The Organization has clearly defined and manages the work environment needed to achieve conformity to product requirements and to promote personnel safety. This activity is part of the cross-functional advanced quality planning
process and annual budgeting process.
7.0 Product Realization
7.1 Planning of Product Realization
The Organization plans and develops the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).
In planning product realization, The Organization determines the following, as appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes and documents and to provide
resources specific to the product;
c) required measurement, verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance;
d) specific to the product and the criteria for product acceptance
e) records to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).
The output of this planning
will be in a form suitable for The Organization method of operation.
The Organization ensures the confidentiality of customer-contracted products and projects under development, and related product information.
The Organization maintains a process to control and react to changes that impact product realization.
7.2 Customer-related Processes
7.2.1 Determination of Customer Requirements Related to the Product
The Organization determines
a) requirements specified by the customer, including the requirements for delivery and for post-delivery activities,
b) requirements not stated by the customer but necessary for specified or
intended use, where known,
c) statutory and regulatory requirements applicable to the product, and
d) any additional requirements considered necessary by the Organization.
Note: Post-delivery activities
include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.
7.2.2 Review of Requirements Related to the Product
The Organization reviews the requirements related to the product. This review is conducted prior to the commitment to supply a product to the customer (e.g. submission of a tender, acceptance of contracts or orders,
acceptance of changes to contracts or orders) and ensures that
a) product requirements are defined,
b) contract or order requirements differing from those previously expressed are resolved, and
c) The Organization has the ability to meet the defined requirements.
Waiving the requirement for a formal review of each order where it is impractical requires customer authorization.
Records of the results of
the review and actions arising from the review are maintained (see 4.2.4).
Where the customer provides no documented statement of requirement, the customer requirements are confirmed by The Organization before acceptance.
Where product requirements are changed, The Organization ensures that relevant documents are amended and that relevant personnel are made aware of the changed requirements.
7.2.3 Customer Communication
The Organization determines and implements effective arrangements for communicating with customers in relation to
a) product information,
b) inquiries, contracts or order handling, including amendments, and
c) customer feedback, including customer complaints.
The Organization has the ability to communicate necessary information, including data, in a customer-specified language and/or format.
7.3 Design and Development – EXCLUSION:
7.4 Purchasing
7.4.1 Purchasing Process
The Organization ensures that purchased products and materials conform to specified purchase requirements and applicable regulatory requirements. The type and extent of control applied to the supplier and the purchased
product are dependent upon the effect of the purchased product on subsequent product realization or the final product.
Where specified by contract, The Organization purchases products, materials and/or services from approved sources.
The Organization evaluates and selects suppliers based on their ability to supply product in accordance
with our requirements. Criteria for selection, evaluation and re-evaluation are established. The Organization performs supplier quality management system development with the goal of supplier conformity with the
ISO9001:2008 technical specification.
Records of the results of supplier evaluations and any necessary actions arising from the evaluation are maintained (see 4.2.4).
7.4.2 Purchasing Information
Purchasing information describes the product to be purchased, including where appropriate
a) requirements for approval of product, procedures, processes, and equipment,
b) requirements for qualification of personnel, and
c) quality management system requirements.
The Organization ensures the adequacy of specified purchase requirements prior to communication to the supplier.
7.4.3 Verification of Purchased Product
The
Organization establishes and implements the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.
Where the Organization or its customer intends to perform
verification at the suppliers' premises, the Organization states the intended verification arrangements and method of product release in the purchasing information.
7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision
The Organization plans and carries out production and service provision under controlled conditions. Controlled conditions include as applicable
a) the availability of information that describes the characteristics of the
product,
b) the scheduling of production in accordance with customer requirements
c) the availability of control plans
d) the availability of work instructions, as necessary
e) the use of suitable equipment,
f) the verification of job set-ups,
g) the availability and use of monitoring and measuring equipment,
h) the implementation of monitoring and measurement,
i) the implementation of preventive and predictive maintenance
for key process equipment, and
j) the implementation of product release, delivery and post-delivery activities.
The Organization maintains a process for communication of information on service concerns to
manufacturing, engineering and design activities.
7.5.2 Validation of Processes for Production and Service Provision
The Organization validates its processes for production and service provision in order to demonstrate the ability of these processes to achieve planned results.
Instances where the resulting output cannot be verified by subsequent monitoring or measurement and as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered. The Organization establishes arrangements for these processes including, as applicable:
a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures,
d) requirements for records (see 4.2.4), and
e) revalidation.
7.5.3 Identification and Traceability
The Organization identifies the product and product status with respect to monitoring and measurement requirements throughout the product realization processes.
Where traceability is a requirement, The Organization controls the unique identification of the product and maintains records. (see 4.2.4).
7.5.4 Customer Property
The Organization exercises care with customer property while it is under its control or being used.
The Organization identifies, verifies, protects and safeguards customer property and personal data provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this is reported to the customer and records are maintained (see 4.2.4).
7.5.5 Preservation of Product
The Organization as applicable preserves the product in order to maintain conformity to requirements during internal processing and delivery to the intended destination. This preservation includes identification, handling,
packaging, storage and protection. Preservation also applies to the constituent parts of a product.
The Organization manages its inventory in order to optimize inventory turns over time and assure stock rotation.
Obsolete material is controlled in a similar manner to nonconforming product. In order to detect possible deterioration, the condition of product in stock is assessed at appropriate planned intervals.
7.6 Control of Monitoring and Measuring Equipment
The Organization has identified the monitoring and measurement equipment needed to provide evidence of conformity of product to determined requirements. MII has established processes to ensure that monitoring and
measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.
Where necessary to ensure valid results, measuring equipment is:
a) calibrated
and/or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for
calibration or verification shall be recorded; (see 4.2.4)
b) adjusted or re-adjusted as necessary;
c) have identification in order to determine its calibration status;
d) safeguarded from adjustments that would
invalidate the measurement result;
e) protected from damage and deterioration during handling, maintenance and storage.
In addition, The Organization assesses and records the validity of the previous measuring results
when the equipment is found not to conform to requirements. The Organization takes appropriate action on the equipment and any product affected. Records of the results of calibration and verification are
maintained (see 4.2.4).
When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application is confirmed.
This is undertaken prior to initial use and reconfirmed as necessary.
Statistical studies are conducted to analyze the variation present in the results of each type of measuring and test equipment system.
The
Organization has defined the scope of its internal laboratory facility. External laboratories are controlled per the requirements of the ISO9001:2008 Technical Specification.
8.0 Measurement, Analysis and Improvement
8.1 General
The Organization plans and implements the monitoring, measurement, analysis and improvement processes needed to
a) demonstrate conformity of the product requirements,
b) ensure conformity of the quality management system, and
c) continually improve the effectiveness of the quality management system.
This includes determination of applicable methods, including statistical
techniques, and the extent of their use. Basic statistical concepts are understood and utilized throughout the company.
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
As one of the measurements of the performance of the quality management system, The Organization monitors information relating to customer perception as to whether customer requirements have been met. The methods for obtaining
and using this information are determined by The Organization, but include and not limited to customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments,
warranty claims, and dealer reports where applicable.
8.2.2 Internal Audit
The Organization conducts internal audits at planned intervals to determine whether the quality management system
a) conforms to the planned arrangements (see 7.1), to the requirements of the ISO9001:2008
Technical Specification and to the quality management system requirements established by The Organization, and
b) is effectively implemented and maintained.
The Organizations Procedure MSM 3.7, Internal Auditing,
documents the responsibilities and requirements for planning and conducting audits, establishing records and reporting results. The audit program is planned and takes into consideration the status and importance of the
processes, products and areas to be audited as well as the results of previous audits. Internal audits cover all quality management system processes, activities and shifts, and include manufacturing process and product
audits. The audit criteria, scope, frequency and methods are defined.
Internal auditors are qualified to audit the requirements of the ISO9001:2008 Technical Specification. Selection of auditors and conduct
of audits ensures objectivity and impartiality of the audit process. Auditors do not audit their own work.
The responsibilities and requirements for planning and conducting audits, and for reporting results and
maintaining records (see 4.2.4) are defined in a documented procedure.
The management responsible for the area being audited ensures that any necessary corrections and corrective actions are taken without undue delay to
eliminate detected nonconformities and their causes. Follow-up activities include the verification of the actions taken and the reporting of verification results.
8.2.3 Monitoring and Measurement of Processes
The Organization applies suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods demonstrate the ability of the processes to achieve planned results.
When planned results are not achieved, correction and corrective action are taken, as appropriate, to ensure conformity of the product.
The Organization takes into consideration the type and extent of monitoring or
measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system.
8.2.4 Monitoring and Measurement of Product
The Organization monitors and measures the characteristics of the product to verify that product requirements have been met for the delivery to the customer. This is carried out at appropriate stages of the product
realization process in accordance with the planned arrangements (see 7.1).
Evidence of conformity with the acceptance criteria is maintained. Records indicate the person(s) authorizing release of product (see 4.2.4).
Product release and service delivery do not proceed until all the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the
customer.
8.3 Control of Nonconforming Product
The Organization ensures that product which does not conform to requirements is identified and controlled to prevent its unintended use or delivery. Procedure MSM 3.8 Control of Nonconforming Product defines the controls
and related responsibilities and authorities for dealing with nonconforming product.
The Organization deals with nonconforming product where applicable by one or more of the following ways:
a) by taking action to eliminate the detected nonconformity;
b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer;
c) by taking action to preclude its original intended use or application.
d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or
use has started.
Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, are maintained where applicable. (see 4.2.4).
The Organization obtains a customer
concession or deviation permit prior to further processing whenever the product or manufacturing process is different from that which is currently approved.
When nonconforming product is corrected it is subject to
re-verification to demonstrate conformity to the requirements. Instructions for rework, including re-inspection requirements, are accessible to and utilized by the appropriate personnel.
When nonconforming product
is detected after delivery or use has started, The Organization takes action appropriate to the effects, or potential effects, of the nonconformity, including prompt notification of the customer.
8.4 Analysis of Data
The Organization determines, collects and analyzes appropriate data to determine 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 includes data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data provides information relating to
a) customer satisfaction (see 8.2.1),
b) conformance to product requirements (see 7.2.1),
c) characteristics and trends of processes and product including opportunities for preventive action, and
d) suppliers.
8.5 Improvement
8.5.1 Continual Improvement
The Organization is committed to the principle of continuous improvement in quality, productivity, cost, technology, and delivery in order to provide our customers with world-class quality products and services and in order to
improve our internal efficiencies and operating results.
The Organization continually improves the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.
Manufacturing process improvement continually focuses upon control and reduction of variation in product characteristics and manufacturing process parameters.
8.5.2 Corrective Action
The Organization shall continually improve the effectiveness of the quality management system with support of the corrective action process. The results of action taken are recorded to provide, as a minimum, evidence of the
achievement of the quality objectives specified in the business plan and customer satisfaction.
The Organization takes corrective action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions are appropriate to the effects of the nonconformities encountered.
A documented
procedure MSM 3.9 is established to define requirements for
a) reviewing nonconformities (including customer complaints),
b) determining the causes of nonconformities,
c) evaluating the need for actions to ensure that
nonconformities do not recur,
d) determining and implementing action needed,
e) record the results of action taken (see 4.2.4), and
f) reviewing corrective action taken.
The Organization analyses parts rejected
by the customer on a timely basis, maintains records of these analyses, and makes them available upon request.
8.5.3 Preventive Action
The Organization personnel use mistake-proofing techniques in the planning of processes, facilities, equipment, and in the resolution of problems to prevent the manufacture of nonconforming product and eliminates the causes of
potential nonconformities in order to prevent occurrence. Preventive actions are appropriate to the effects of the potential problems.
A documented procedure MSM 3.10 is established to define requirements for
a) determining potential nonconformities and their causes,
b) evaluating the need for action to prevent occurrence of nonconformities,
c) determining and implementing action needed,
d) records of results of action taken (see 4.2.4), and
e) reviewing preventive action taken.
UNCONTROLLED DOCUMENT
11/18/2009
FOR INFORMATION ONLY
Microspace Instruments Inc.
|
