QUALITY MANUAL
Table of Contents
1 SCOPE....................................................................................................................... 2
2 REFERENCES............................................................................................................ 2
3 DEFINITIONS........................................................................................................... 2
4 QUALITY SYSTEM................................................................................................... 2
4.1 Management Responsibility...................................................................................... 3
4.2 Quality System......................................................................................................... 4
4.3 Contract Review...................................................................................................... 5
4.4 Design Control......................................................................................................... 5
4.5 Document and Data Control..................................................................................... 5
4.6 Purchasing............................................................................................................... 6
4.7 Control of Customer Supplied Product..................................................................... 6
4.8 Product Identification and Traceability...................................................................... 7
4.9 Process Control....................................................................................................... 7
4.10 Inspection and Testing.............................................................................................. 7
4.11 Control of Inspection, Measuring, and Test Equipment.............................................. 8
4.12 Inspection and Test Status........................................................................................ 8
4.13 Control of Nonconforming Product.......................................................................... 9
4.14 Corrective and Preventive Action............................................................................. 9
4.15 Handling, Storage, Packaging, Preservation, and Delivery....................................... 10
4.16 Control of Quality Records.................................................................................... 10
4.17 Internal Quality Audits............................................................................................ 10
4.18 Training................................................................................................................. 10
4.19 Servicing................................................................................................................ 10
4.20 Statistical Techniques............................................................................................. 10
This Quality Manual provides the foundation for our Quality System. Our Quality System has been designed to provide a consistent and understandable framework of controls for all processes and procedures performed by Shareway Industries Incorporated.
ANSI/ASQC Q9002-1994 Quality Systems-Model for Quality Assurance in Production, Installation and Servicing.
ANSI/ASQC Q9004-1994 Quality Management and Quality Systems Elements-Guidelines.
ANSI/NCSL Z540-1 American National Standard for Calibration Systems.
ISO 8402: 1994 Quality Management and Quality Assurance - Vocabulary.
ISO 10012-1: 1992 Quality Assurance Requirements for Measuring Equipment - Part 1: Meteorological Confirmation System for Measuring Equipment.
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The periodic comparison of measurement and test equipment to traceable standards to determine their accuracy. |
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Contract: |
Agreed upon requirements, whether by formal or verbal purchase order. For the purposes of “contract review”, this includes any “request for quote”. |
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Documentation: |
Written references or annotations in either electronic or hard copy format. |
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Inspection: |
Verification of product compliance to stated requirements. |
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Management Review: |
Formal evaluation of quality system performance by management personnel to verify its compliance with the quality policy and objectives. |
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Nonconformance: |
Deviation from stated requirements. |
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Policy: |
A guiding principle, plan or course of action intended to influence decisions, actions, and results in a manner consistent with goals and objectives. |
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Procedure: |
Specified manner by which to perform an activity, by describing when, where, with whom, and by whom. |
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Product: |
Physical materials, whether raw, assembled, or processed which are the result of activities or processes. |
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Subcontractor: |
Any individual or organization who furnishes materials, products or services. |
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Traceability: |
The availability of documentary proof of origin. (re; calibration, typically traceable to NIST standards). |
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Work Instruction: |
Documentation of how to do something, a detailed description of a work activity. Generally used where training or experience alone can not ensure consistent execution of a task. |
Shareway Industries,
Dedicated to Achieving Quality, Craftsmanship, and Customer Satisfaction.
It is the desire and policy of Shareway Industries to:
„ seek continuous improvements in all aspects of our operations,
„ fulfill our customers’ requirements to their full satisfaction,
„ promote partnerships in growth with our customers and vendors,
„ encourage all members of the Shareway team to strive for ever higher degrees of professionalism and craftsmanship,
„ instill in each individual employee, a personal responsibility for quality and customer service.
Shareway Industries has established this Quality Policy to provide guidance for all company personnel regarding the companies commitment to quality and its quality objectives. The Quality Policy is intended to communicate our goals, expectations and desires in meeting the needs of our customers. To ensure that the Quality Policy is understood, and implemented throughout the company, it is included in the company’s training system (QM 4.18).
All employees of Shareway Industries are responsible for maintaining the quality of goods and services provided to our customers. Each employee has both the authority and the responsibility to stop any process which they in good faith believe to be operating outside the boundaries of our quality expectations.
The companies resources are constantly monitored and updated daily. All employees are encouraged to participate in this process. Company management monitors incoming orders, backlog, employee and customer input to determine when and where equipment improvements and acquisitions should be undertaken.
The company President maintains appointments to the position of Quality Assurance Manager. The Q.A. Manager has defined authority and responsibility to establish, implement and maintain the company Quality System.
The Q. A. Manager is required to present Quality System performance reports to the company President and other members of the management team. These reports are reviewed by management and used as a basis for improvements to the Quality System.
The Quality System is formally reviewed by management a minimum of once per calendar year. The review includes; Quality system performance report , resource assessments, Quality Policy reaffirmation, Corrective Action reviews, review of customer complaints, and any other relevant business.
Shareway Industries Inc. has established and maintains a documented Quality System as a means of ensuring product compliance with customer requirements and expectations. This Quality Manual outlines the structure of the Quality System. This version of the Quality Manual and has been designed to maintain compliance with MIL-I-45208 and MIL- Q-9858A while serving as a bridge to full ANSI/ASQC Q9002-1994 compliance and certification. Our Quality System documentation provides a structured framework and consists of the Quality Manual, Quality Procedures, Work Instructions, and Forms.
Quality Procedure QP 4.2.2 provides for the preparation and design of documented procedures consistent with the requirements of ANSI/ASQC Q9002-1994.
Quality Procedure QP 4.2.2.1 provides for the preparation and design of documented work instructions consistent with the requirements of ANSI/ASQC Q9002-1994.
Quality Procedure QP 4.2.2.3 provides guidance for the preparation, design and control of forms used to supplement our procedures and work instructions.
Quality Procedure QP 4.2.3 defines and details the methods utilized to ensure that requirements for quality are met.
Each incoming purchase order and request for quote received by Shareway Industries Inc. is evaluated to verify that all customer requirements are clearly understood, and that the requirements are within our capabilities to fulfill.
All incoming documentation and information is reviewed prior to it’s use. Drawings are verified for correct revision status. The customer will be consulted to confirm any requirements needing clarification.
When an amendment to contract becomes necessary, such amendment shall be documented and approved by the customer. Where such amendment impacts an order in progress, (example: an updated drawing revision), our Work Orders (QM 4.9) and all impacted documentation shall be adjusted as soon as reasonably possible.
All documentation regarding the contract review process shall be maintained in accordance with QM 4.16.
Shareway Industries Inc. currently performs no design work.
All documentation utilized which presents a potential impact on the quality of product or services provided by Shareway Industries Inc. are controlled by documented procedures.
All documentation is reviewed and approved by management prior to release. A master copy of all approved documentation shall be retained and shall indicate by date and initials the authority releasing it. Where existence of an outdated copy may compromise quality, a copy identification record is maintained with the master copy.
Where an existing document has been revised or otherwise changed, a new or revised master copy will be retained. When appropriate, current copies may be revised provided they clearly indicate by date and initials the authority making the revision. When a document is rendered obsolete all known copies are either destroyed or clearly marked “Reference Only”.
Where the purchase of products or services presents a potential impact on quality, the following procedures are utilized to insure the necessary quality.
Subcontractors utilized by Shareway Industries are selected, evaluated and monitored for their ability to consistently meet specified requirements. The level of scrutiny exercised shall be consistent with the potential quality impact.
Records of subcontractor evaluations are maintained in accordance with QM 4.16.
Purchase orders submitted by Shareway Industries are reviewed and compared with drawing and contract requirements where applicable. The purchase order must either explicitly state all requirements or reference an accompanying document which does.
When purchase orders submitted by Shareway Industries Inc. specify the need for verification of purchased products at the subcontractor’s premises, the purchase order will state the arrangements made for such verification and release of the purchased product.
Where our customers require access rights for verification of subcontracted product and customer purchase order or contractual agreement defines these access rights, Shareway Industries will stipulate on submitted purchase orders the same said access rights as requirement for acceptance of the purchase order by our subcontractor.
All customer-supplied product received by Shareway Industries shall be preserved from damage, deterioration and theft in accordance with standard industry practices.
All product processed by Shareway Industries is tracked by means of our Work Order number. The Work Order number provides traceability to all records maintained regarding the product assigned that number. Throughout processing, each lot, batch, or piece is marked or tagged with this number. Where our customer has additional traceability requirements, such requirements are specified on our Work Order and maintained.
Planning issues Work Orders to provide controlled production procedures which ensure that necessary data (including workmanship criteria), is conveyed through all phases and processes.
Process control records are maintained in accordance with QM 4.16
Shareway Industries utilizes a documented preventive maintenance system which is utilized to ensure the continuing capability of our equipment.
Inspection and testing are performed and recorded to ensure product compliance with specified requirements. The work order, inspection and process control procedures, detail the mandatory minimum inspections to be performed. All personnel share the responsibility and authority to perform additional examinations as needed.
Quality Procedure QP 4.10.2.1 details our process to ensure that incoming product is not used or processed before verification.
Quality Procedure QP 4.10.2.2 defines the methods used to determine the necessary extent of verification for incoming product.
Where “urgent demand” requires release of incoming product prior to completion of the above procedures the Work Order shall indicate this release in order to allow immediate recall in the event of nonconformity to specified requirements.
For each manufacturing operation, a “first article” inspection is conducted by the operator. Additionally, documented “first article verifications” are required for multiple piece runs and whenever critical features are established. First article verifications are usually performed by inspection personnel. When no inspector is available, verification may be performed by any other qualified member of production. Operators are responsible for monitoring product quality during the run. Inspectors perform additional in-process checks at their discretion.
Whenever product requires out-plant processing, it must be released by an inspector or manager. This release is documented on our Work Order and must indicate when and by whom it was released.
Final inspection and testing are performed by our inspection personnel. Inspection personnel have the authority and responsibility to withhold shipment of any product which does not meet specified requirements. Inspection personnel determine the required extent of final verification with consideration to status of in-process inspection results.
Inspection and test records are maintained in accordance with QM 4.16. These records are required to identify the authority responsible for release of product.
All measuring and test equipment utilized to demonstrate product conformance to specified requirements shall be controlled and properly maintained. The measuring and test equipment will be calibrated or verified with traceability to recognized standards.
Our inspection, measuring and test equipment are maintained and used in a manner which ensures that measurement uncertainty is known and is consistent with the required measurement capability. Traceable calibration is maintained on “standards” which are subsequently used for verification of all shop measurement equipment. Any equipment which does not properly perform is either retired or withheld until repaired.
The inspection and test status of all product shall be known throughout all processes.
Our Work Orders and Inspection Tags are used to identify the inspection and test status of product and to ensure that only product that has been approved for release is actually released.
Whenever product or material fails to conform to specified requirements the nonconformance will be identified, documented, and controlled to prevent its’ inadvertent use or delivery. The nonconformance will then be evaluated by the Material Review Board (MRB) which has the authority and responsibility for determining disposition of nonconforming product. Where required or deemed prudent, the customer will be notified of the nonconformance and may be requested to participate in determining disposition of nonconforming product.
Product or material that has been repaired or reworked must be verified for acceptance to the original requirements prior to release.
All nonconforming product is tagged and / or withheld pending review and disposition. Inspection and management personnel have sole authority to remove an inspection tag once it has been placed on product.
Disposition of nonconforming product involves assignment of one or more of the following.
Rework: Specified requirements can be met by further normal processing.
Repair: Use of special processing to restore product. May include; welding, plating, heat treatment, etc.
Use as is: “Fit, Form and Function” are not adversely affected.
Scrap: Product is beyond repair and must be replaced.
All inspection and management personnel participate in the Material Review Board. Members with relevant knowledge and / or experience perform each review and determine the product disposition as well as the processing required to restore the product to conformance. Exception to review requirement is allowed for Rework. All production members are permitted to initiate Rework as part of normal processing.
Our corrective and preventive action procedures are invaluable tools for our ongoing efforts to continuously improve our operations. They provide a structured system, which ensures that causes and potential causes of nonconformities are examined with an eye towards system refinements, which can reduce or eliminate future nonconformities.
Quality Procedure QP 4.14.2 documents our corrective action process.
Quality Procedure QP 4.14.3 documents our preventive action process.
Shareway Industries uses established methods for ensuring the proper handling, storage, packaging, preservation, and delivery of product to meet the customers specifications and/or expectations.
Quality Procedure QP 4.16 establishes requirements for the control and management of quality records within Shareway Industries Inc. Our quality records provide evidence of conformance to customer specifications and the effective operation of our quality system. Records are retained for a minimum period of ten years.
A formal internal quality audit system is under development. This system will monitor all aspects of the quality system to ensure that it is functioning within expectations.
Our training system provides a documented system for the review of employee skills, qualifications, and capabilities. Employees of Shareway Industries receive training regarding the company Quality Policy and Quality System Procedures to better able them to work within the Quality System.
Servicing is not currently a function performed by Shareway Industries Inc.
We review our quality and production processes on a regular basis. During this review we examine the potential benefits that statistical techniques may provide. When a potential need is identified, further investigation is conducted. This is done to ensure that any implementation of statistical techniques would provide a true benefit without compromising either quality or customer requirements.
The selection and implementation of statistical techniques will be done by the Q.A. Manager.
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Shareway Industries, Inc. ••• 2526 E St. NE, Auburn,
WA 98002 ••• 253-804-0670 ••• Fax 253-804-0667
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