sor quality manual

1Form 1217 | Revision 11 (10.28.13) | 8701-001 SOR QUALITY MANUAL | sorinc.com8701-001/Revision 11/Form 1217

Quality Manual

We Deliver Quality on Time

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sorinc.com | SOR QUALITY MANUAL 8701-001 | Revision 11 (11.11.13) | Form 1217

Table of Contents

Preamble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11.2 Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

4.0 Quality Management System 4.1 General Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 4.2 Documentation Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 4.2.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 4.2.2 Quality Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 4.2.3 Control of Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 4.2.4 Control of Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

5.0 Management Responsibility 5.1 Management Commitment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 5.2 Customer Focus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 5.3 Quality Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 5.4 Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 5.4.1 Quality Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 5.4.2 Quality Management System Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 5.5 Responsibility, Authority and Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 5.5.1 Responsibility and Authority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 5.5.2 Management Representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 5.5.3 Internal Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 5.6 Management Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 5.6.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 5.6.2 Review Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 5.6.3 Review Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

6.0 Resource Management 6.1 Provision of Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 6.2 Human Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 6.2.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 6.2.2 Competence, Awareness and Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 6.3 Infrastructure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 6.4 Work Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

7.0 Product Realization 7.1 Planning of Product Realization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 7.2 Customer-related Processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 7.2.1 Determination of Requirements Related to the Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 7.2.2 Review of Requirements Related to the Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 7.2.3 Customer Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

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Form 1217 | Revision 11 (11.11.13) | 8701-001 SOR QUALITY MANUAL | sorinc.com

7.3 Design and Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 7.3.1 Design and Development Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 7.3.2 Design and Development Inputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 7.3.3 Design and Development Outputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 7.3.4 Design and Development Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 7.3.5 Design and Development Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 7.3.6 Design and Development Validation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 7.3.7 Control of Design and Development Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 7.4 Purchasing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 7.4.1 Purchasing Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 7.4.2 Purchasing Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 7.4.3 Verification of Purchased Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 7.5 Production and Service Provision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 7.5.1 Control of Production and Service Provision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 7.5.2 Validation of Processes for Production and Service Provision . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 7.5.3 Identification and Traceability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 7.5.4 Customer Property . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 7.5.5 Preservation of Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 7.6 Control of Monitoring and Measuring Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 8.0 Measurement, Analysis and Improvement 8.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 8.2 Monitoring and Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 8.2.1 Customer Satisfaction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 8.2.2 Internal Audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 8.2.3 Monitoring and Measurement of Processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 8.2.4 Monitoring and Measurement of Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 8.3 Control of Non-Conforming Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 8.4 Analysis of Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 8.5 Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 8.5.1 Continual Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 8.5.2 Corrective Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 8.5.3 Preventive Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Appendix A SOR Executive Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Appendix B SOR Quality Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Appendix C Revisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Appendix D SOR Process Plans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 4.0 Quality Management System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 5.0 Management Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 6.0 Resource Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 7.0 Product Realization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 8.0 Measurement, Analysis and Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

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PreambleThis Quality Manual sets forth the requirements of the Quality Management System (QMS) to ensure the quality of products produced by SOR Inc., Lenexa, Kansas, U.S.A.

OverviewSOR is a producer of high-quality pressure and level measuring instruments for industrial service. We serve a global market of oil and gas, chemical, petrochemical, and power industries through a network of independent sales Agents. Our products are suitable for a broad range of safety systems, control processes, and related applications.

SOR enjoys the qualities of a small business environment. In addition to reputable products, our business is built on the relationships between our employees, our Agents, and our customers. This company promotes the values of teamwork and collaboration, a customer-focused mindset throughout the organization, and a general dedication to business excellence.

We make it our business to continuously improve our service and product strategies to be responsive to customer requirements. Our Quality Policy is We Deliver Quality on Time. We measure and challenge our business performance by these words.

This manual applies to these instrument lines, and is written to comply with the applicable elements of the type described in the EC type examination certificate and ISO-IEC 80079-34 requirements. Products produced under the 10CFR50 Appendix B Program are excluded from this manual. This manual and the programs therein are approved and enforced by the management of SOR.

SOR Mission Statement: We leverage our ability and willingness to develop engineered solutions from standard platforms to create value for our customers.

1.2 ApplicationNo exclusions.

ScopeThe following scope of registration applies: SOR designs, develops and produces electro-mechanical pressure, temperature, level, and flow switches, as well as electronic pressure, temperature, level, and flow controls for industry.PR

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2Form 1217 | Revision 11 (11.11.13) | 8701-001 SOR QUALITY MANUAL | sorinc.com

4.0 Quality Management System All procedures referenced in Appendix E.

4.1 General Requirements

SOR has established a QMS consistent with the requirements of ISO 9001:2008 and its internal quality policy. SOR documents, implements, and maintains processes for management activities, provision of resources, and product realization and measurement. The system works to ensure that SOR products conform to published specifications as well as internal quality standards. The system is designed to encourage and facilitate the continuous improvement of business operations.

When SOR chooses to outsource any process that affects conformance with product quality, control over such outsourced processes shall also be identified within the quality management system.

The CEO is responsible for establishing an organizational structure for the business and providing executive leadership for each department. Human Resources maintains SOR organizational charts. Department leadership identifies the processes needed for the application of the QMS throughout the organization, as well as the sequence and interaction of these processes. Department leadership also identifies resources and information required to operate and monitor their processes, and has responsibility for the implementation of resources within the department. This includes:

i. Identifying resource requirements for expected production levels, manpower and capacity assumptions, and relevant business objectives as reflected in the annual plan.

ii. Creating job descriptions that define the interrelation and responsibilities of each employee, and the assignment of trained personnel to management, performance, and verification activities.

iii. The monitoring and reporting to a monthly review of actual activity vs. expectations in terms of business objectives and financial performance. Sources of

analysis would include planning budgets, sales projections, a review of open positions, and any other pertinent information regarding the planning or execution of the SOR annual business plan. Adjustments to projections are made based upon this review activity, creating a revised plan. Steps i and ii are then repeated for the revised plan, and monitored accordingly.

To ensure the effectiveness of the QMS, every year a series of internal audits are conducted by the Quality Department, followed by an independently conducted audit of our QMS by a qualified ISO Certification agency. This annual audit cycle, along with the Management Review process (ref. Section 5.6), work to ensure the adequacy of the operation and control of the System. The Quality Assurance official is responsible for assuring that trained personnel conduct the audits.

The results of these audits and reviews are documented, and any non-conformances or other action items are followed up by the Quality Review Board (QRB). To achieve planned results, the QRB has the responsibility to review and maintain current quality objectives (ref. Section 5.4.1).

QRB is tasked with ensuring the availability of resources and the information necessary for employees to monitor, measure, analyze, and subsequently take action necessary to achieve planned results and the continual improvement of the processes.

The Agency Authority, or The Agency Coordinator, informs the Notified Body, holder of the ATEX QAN/IECEx QAR of any change to the quality system that involves substantial updating of the quality system relevant to the type of protection, including changes to personnel Authorized Person (ref. Section 5.4.1).

The CEO is ultimately responsible for deeming the proper attention to non-conformances and the continual improvement, appropriateness, and effectiveness of the System at SOR, in accordance with the International Standard.

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Form 1217 | Revision 11 (10.28.13) | 8701-001 SOR QUALITY MANUAL | sorinc.com

8701-001/Revision 11/Form 1217

Quality Manual

We Deliver Quality on Time

4.2 Documentation Requirements

4.2.1 GeneralSOR maintains a system of documented procedures consistent with the requirements of ISO 9001:2008 and the SOR internal quality policy. The term documented procedure as it appears within the SOR QMS refers to a procedure that is established, documented, implemented, and maintained in any form or type of medium by its QMS. The QMS documentation has been designed to an extent deemed appropriate, given consideration to the size and type of business, the complexity of the processes and interactions, and the skills, training, and abilities associated with personnel involved in fulfilling the various activities (ref. Section 4.2.3).

SOR has a documented Quality Policy (ref. Preamble, ref. Section 5.3). SOR Key Performance Indicators (KPI) are also documented and established at relevant functions and levels within the organization (ref. Section 5.4.1). All KPI are measurable and consistent with the Quality Policy.

The SOR quality documentation is designed to ensure effective planning, operation and control of its processes. All documents are designed to work with a four-tier documentation structure:

Level 1: SOR Quality Manual This top-level document is a statement of the

SOR Quality Policy. It includes appendices of a revision history, organization charts, and the Tier 2 Process Maps.

Level 2: Process Maps Flow charts map the process in response

to each section of the ISO 9001:2008 Standard (included in appendix E). Process Maps also reference the Key Procedures and Work Instructions that are needed to perform the work to the stated quality standards.

Note: The processes and methods of all quality plan operations are documented in this standard flow chart format, as shown in appendix E. Should another format be required, the SOR Quality Assurance official is responsible for the interpretation and translation to the new format, and assuring the accuracy of the quality plan document.

Level 3: Procedures & Work Instructions These describe how jobs are accomplished.

In addition to instructions for carrying out the activities, they also reference the records where the activity and QMS information are documented.

Level 4: Records These are considered special documents that

record current and historical evidence of work performed (ref. Section 4.2.4).

4.2.2 Quality ManualThis Quality Manual is established and maintained to meet the requirements of the ISO 9001:2008 quality standard, and other certifications or exclusions listed in the Preamble of this Quality Manual. It serves as a statement of the scope of the Quality Policy and the QMS, and to describe interactions between processes of the QMS. It includes Level 2 Key Process Maps (Appendix E) and references the supporting procedures (Level 3) for each section of the manual, and, when necessary, provides details and justification for any exclusions to the standards and certifications listed.

4.2.3 Control of Documents SOR has established a documented procedure to control all documents and data that are required to maintain a manufacturing system that meets the requirements of ISO 9001:2008 and the standards listed in the Preamble. Records are a special type of document and are controlled according to the requirements given in Section 4.2.4.

Documents are classified under and controlled by five control systems:

i. Documented procedures, including flow charts and work instructions, are maintained by the Document Control procedure. Human Resources issues and revises these procedures.

ii. Design and manufacturing drawings are maintained by the Design Engineering Department. Any customer drawings required for manufacturing are also controlled by this system. The Engineering Change Order procedure controls these drawings.PR

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iii. Catalogues and forms are maintained by the Marketing Communications Department and

are controlled by the Issuing and Revising Forms procedure.

iv. Documents of external origin pertaining to agency standards are maintained by the Agency Authority. The Engineering Department keeps a copy of the latest revision of these standards.

v. Documents of external origin pertaining to referenced industry standards are maintained by the Quality Department. The Quality Department keeps a copy of the latest revision of these standards.

Documents are maintained in a legible and readily identifiable condition. The latest revision of a procedural document is issued, to all points of use, and, as deemed pertinent, any other operations essential to the effective functioning of the QMS. Changes between the former and current revision status of documents are identified with the documents.

A master list of documents, identifying the current revision status, is readily available to prevent the use of invalid or obsolete documents. Documents of external origin are identified and their distribution controlled. Invalid or obsolete documents are promptly removed from all files to guard against unintended use.

Obsolete documents that are retained for legal, knowledge-preservation, or any other purpose are suitably identified.

Properly authorized personnel will review and approve, and as necessary, update and re-approve documents and data for adequacy prior to issue. Unless specifically designated otherwise, the same functions or organizations who perform an original review and approval will be responsible for the approval of any subsequent changes to the documents.

Access to pertinent background information relating to proposed changes to documents will be provided to personnel responsible for the review. The nature of changes to these documents will be identified in the document or appropriate attachments, whenever practical.

4.2.4 Control of RecordsSOR has established records to provide evidence of conformity to requirements and effective operation of the QMS. SOR has established procedures for the identification, collection, indexing, filing, storage, maintenance, retention time, and disposition of quality records. Such documented evidence is considered a quality-related record when the document has been completed and approved by personnel responsible for the record. Examples may include inspection and test records, records confirming traceability, evidence of verification, or corrective and preventive actions. Like other documentation, records can be in any form or type of medium (ref. Section 4.2.1).

Quality records are required to be legible and identifiable to the product or activity involved. They are stored and maintained in such a way that they are readily retrievable from facilities that provide a suitable environment to minimize deterioration or damage and to prevent loss.

When a sub-contractor provides work, the records of that work are maintained in the same manner as other SOR quality records. When required by contract, access to records is provided to a customer or customers Agent for an agreed period.

SOR products satisfy the requirements of approval agencies worldwide. Often, a common design is capable of multiple approvals. In other cases, modified construction techniques are necessary to meet specific agency requirements.

Underwriters Laboratories

Factory Mutual

Canadian Standards Association

ATEX (BASEEFA, DEMKO, KEMA, SIRA)

CE Marked: EMC Directive 89/3367/EEC

Heavy Industrial (Self Certified)

JIS/RIIS Japanese Industrial Standards

SAA Australia Standards Association

GOST

AppRovAl AgencIeS

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5.1 Management Commitment

The Quality Management System (QMS) is a central concept around the day-to-day life at SOR. The nature of the SOR business is such that the importance of meeting a variety of customer application and agency requirements has been a way of life for more than 60 years, and over the past decade ISO has become the vehicle for managing this effort to a high standard. Department leadership is responsible for ensuring availability of resources (ref. Section 6.1) and information, including statutory, regulatory and other customer requirements, necessary to operate and monitor processes within their departments (ref. Section 4.2.1) and the reporting of trend data concerning their departments to the company.

SOR reinforces the Quality Policy and QMS in a number of ways (ref. Section 5.3). The SOR Quality Policy is presented as the defining statement for business performance (ref. Preamble). The SOR annual business plan contains measurable business objectives, driven by the annual Management Review (ref. Section 5.6), that support continuous improvements aligned with the Quality Policy (ref. Section 5.3). Posting of trend data helps to ensure the promotion of the business objectives throughout the organization.

5.2 Customer Focus

SOR works to ensure that the customers requirements for any order are adequately determined prior to being accepted by the company (ref. Section 7.2.1), and that product requirements not recognized by the customer are also accounted for (ref. Section 7.2.2).

With the aim of enhancing customer satisfaction, the Sales & Marketing departments solicit customer feedback from a statistical sampling of delivered products. The results are tabulated and analyzed by the Marketing official and reported at least annually to SOR Management. Regional

5.0 Management Responsibility All procedures referenced in Appendix E.

Managers and Product Managers are in direct contact with customers and reps on a daily basis and communicate significant customer comments through the Customer Service System.

5.3 Quality Policy

We make it our business to continuously improve our service and product strategies to be responsive to customer requirements. Our Quality Policy is We Deliver Quality on Time. This is a dynamic objective that challenges our business performance through continuous improvement (ref. Preamble.)

To maintain this reputation with our served markets, the SOR business objectives support aspects of design, manufacturing, delivery, and service. Specifically, SOR designs, develops, and produces select lines of pressure, temperature, level and flow-sensing electro-mechanical switches, and electronic controls for industrial applications.

The annual business plan is presented to and approved by the Board of Directors, and contains measurable business objectives that maintain the business plan within the thresholds of the Quality Policy. The Management Review accounts for the suitability of the Quality Policy and the QMS in general as related to business objectives.

SOR works throughout the year to continually improve the quality management system and ensure it is understood, implemented, and maintained. This is accomplished by implementing employee education programs, by involving SOR employees with the internal audit process, by making employees responsible for posting and presenting current trend data to the group, and by opportunistically reviewing trend data at Managers meetings and any employee meeting or gathering.

5.4 Planning

5.4.1 Quality ObjectivesSOR has a process that controls the establishment of quality objectives as defined in Section 4.1.

September 2006 Representative Satisfaction Survey Summary: 25% responded to the survey (100 out of 407) Overall satisfaction was 1.29 (1 = satisfied, 2 = neutral, 3 = unsatisfied) o On Time Delivery = 1.74 o Product Quality = 1.41 o Customer Service = 1.15 96% are very satisfied or satisfied with their overall experience with SOR The majority of Reps were satisfied with all product lines, except nuclear where 30% were neutral 37% only hear complaints from customers once a year and 29% hear complaints once a month; 71% of complaints are reported to SOR 40% + feel that our Customer Service performance is excellent 85% are satisfied with the training sessions that are offered by SOR When asked if there was one thing that they would improve about SOR, 14% mentioned delivery and 32% mentioned items related to new product development/quality improvement

September 2006 Rep Satisfaction Survey Responses

North America

Middle East

Latin America

Europe

China

Australia/NZ

Asia

51%

7%

7%

14%

7%

3

11%

Observations: 12% replied that they somewhat disagree is the statement Delivers products on time

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ii. a special customer requirement, usually required with contracts for a product with a custom designed feature.

iii. a new product, developed as part of the new product development process.

iv. any event that is determined to impact the QMS.

The following considerations are given, as appropriate, in meeting the specific requirements for products, projects, and/or contracts. It is the responsibility of the Quality Assurance official, working with various department leadership, to ensure that there are adequate resources to carry out the foregoing system.

I. Quality plans are initiated, prepared, and then approved by the Quality Assurance official.

II. The Quality Assurance official is responsible for verifying that the identification and acquisition of any controls, processes, equipment, fixtures, resources, and skills that may be needed to achieve the required quality level of SOR products is met. Quality plans must clearly define these elements where applicable, before they are approved by the Quality Assurance official. When necessary, supporting procedures and tests will be developed and referenced in the quality plan.

III. The Quality Assurance official is responsible for ensuring that the design, the production process, installation, service, inspection, and test procedures meet and are in agreement with the quality plan objectives, and are documented accordingly.

IV. When required by a nonconformance report, design change, or changes in testing instrumentation, the QMS will be updated accordingly for quality control and inspection, and testing techniques.

V. When new development activity is authorized, the Quality Assurance official approves a specific quality plan supporting, plus identifying, any processes or inspection requirements that go beyond current capabilities. Resources are allocated in the plan to develop these requirements along with milestones for completion to ensure that they are available and operative to support the overall plan.

SOR Key Performance Indicators (KPI) are derived from both internal and external sources and are supportive of the Quality Policy.

Internal sources include identified non-conformances from product specifications and/or the QMS, from identified preventive actions related to continuous improvement, from forecasted expectations, and from general experience; i.e. history.

External sources include documented customer feedback, returned product, the SOR Agents, various field sources, expectations and history.

Part of the criteria for the establishment of a quality metric is that it be translatable to measurable data that can be trended in a visual format. SOR management maintains these metrics; it monitors the various aspects of the QMS with a defined set of measurable data and, if it deems necessary, proposes additions or modifications of the metrics.

In order to ensure that the SOR KPI are communicated and understood throughout the company, SOR employees are assigned responsibility for posting trend data on a current basis on bulletin boards throughout the company, and occasionally present summations of the trends to the rest of the organization in company meetings. Making the relevant functions responsible for explaining their own performance versus a quality objective not only ensures the awareness of the objectives at relevant functions and levels, but also promotes the concept of local continuous improvement cycles in the mind of every employee.

5.4.2 Quality Management System Planning SOR maintains a QMS planning system in support of the manufacturing of its basic product lines and product offerings to the specifications defined by the annual plan (ref. Section 4.1). The review and approval practice of the document control process (ref 4.2.3), along with continued process monitoring, ensure the integrity of the QMS as changes are introduced through the business planning cycle.

A quality plan provides a summary of the affected processes within the QMS. There are four conditions that require quality planning:

i. the basic product, in support of standard product line offerings. PR

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VI. The in-house verification requirements of the SOR QMS are identified within the Quality department organization chart. All verification activities connected with SOR products are the responsibility of the Quality Assurance official, who has direct accountability and authorization to the President and CEO for any product quality or safety considerations.

VII. Quality plans should have clear objective standards of acceptability criteria for all features and requirements. If a subjective element is involved, a method should be developed and documented for a qualifying acceptance and/or rejection.

VIII. As appropriate, records will be identified, prepared, and stored that document the quality plan verification activities, as described in Section 4.2.1 of this Quality Manual.

The Quality Assurance official is responsible for approving quality plans as new projects proceed. Changes to the quality plan are approved by the Quality Assurance official during project development. The plans are issued and revised per the document control procedure after the project is released for production.

All products will be covered by a quality plan that identifies suitable verification of the integrity of the product at appropriate stages of the development and manufacturing process.

Customer requirements may call for a special quality plan design to meet a contractual requirement. The Quality Assurance official is responsible for the design of the special quality plan and submits it to the appropriate department(s) for review and approvals.

5.5 Responsibility, Authority and Communication

All procedures referenced in Appendix E, 001-005

5.5.1 Responsibility and AuthorityResponsibility and authority associated with all job functions are documented and communicated in formal job descriptions.

With regard to the SOR Quality System, each SOR employee has the responsibility, authority, and an obligation to stop any work which is perceived to be nonconforming, or which might subsequently degrade

the quality of SOR products. Regardless of whether managing, performing, or verifying work, each employee has the following authority:

i. To fill out a Non-Conformance Report (NCR) (ref. Section 8.3) to initiate action to prevent the occurrence of any nonconformity relating to the product, process, or QMS.

ii. To initiate, recommend, and suggest solution(s) as reviewed and approved by the QRB.

iii. The QRB has the responsibility and authority to verify that the solutions approved on the NCR have been implemented.

Employee responsibility and authority is communicated internally during employee training and externally with vendors and Agents, who also have input to the QMS regarding a perceived NCR.

5.5.2 Management RepresentativeThe Management Representative is appointed by, and is responsible to, the CEO for the overall QMS. Melanie Dirks is the Quality Assurance official at SOR and serves as the Management Representative. Her address, phone number, and e-mail address are as follows: Ms. Melanie Dirks, SOR Inc. 14685 West 105th Street Lenexa, KS 66215 U.S.A. (913) 888 2630 / [email protected]

The Management Representative has the responsibility for ensuring that a QMS is established, implemented, and maintained in accordance with the ISO 9001:2008 Standard and other standards listed in the Preamble of this Quality Manual. The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system, or designating a representative for such an assignment.

The Management Representative has the responsibility to report on the performance of the SOR QMS to top management and directly to the CEO when it is deemed that actions are not being adequately addressed or corrected. The Management Representative is also responsible for working with department leadership to ensure the promotion of awareness of customer requirements (ref. Section 5.2) as a basis for improvement to the QMS throughout the organization.PR

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5.5.3 Internal Communication SOR reinforces the Quality Policy and Quality Management System in a number of ways to ensure that the program is understood, implemented, and maintained:

i. The SOR Quality Policy is readily displayed and communicated throughout the business.

ii. The SOR annual business plan contains measurable business objectives that support an orientation with the Quality Policy (ref. Section 5.3).

iii. The Quality Review Board (QRB) meets regularly for the purpose of reviewing quality performance and the QMS systems effectiveness, identifying the root cause of deviations, and initiating preventive and corrective actions.

iv. As a regular function of the QRB preventive and corrective action status is reviewed by the Quality Assurance official or a designate from the Quality department, to promote continuous awareness and follow-up.

v. Current QMS Performance Indicators data posted around the building ensures awareness of business objectives and awareness of local improvement cycles in the mind of every employee.

vi. The presentation and review of trends and results at employee meetings throughout the year give employees visibility to progress, and the annual audit and Management Review process facilitates

continuous improvement with the re-forecasting of business objectives.

5.6 Management Review

5.6.1 GeneralThe CEO and the executive staff conduct the Management Review of the SOR QMS a minimum of once a year to ensure continuing suitability, adequacy, and effectiveness in satisfying the requirements of ISO 9001:2008, as well as the SOR Quality Policy and stated business objectives.

The records of the Management Review are kept on file by the Quality Department.

The CEO is responsible for ensuring the correction of any deficiencies, and for writing an assessment of the QMS suitability and effectiveness, including opportunities to improve or needs for change to the QMS. The review initiates a review and update of the SOR KPI, and even drives consideration of the Quality Policy on an annual basis.

5.6.2 Review Input The Management Review consists of analysis of internal audits, records of previous reviews, non-conformance reports, corrective action records, preventive action records, customer feedback, QRB trend reports, return reports, changes that could affect the quality management system, and/or any other pertinent information that reflects the performance of the QMS.

The Quality Assurance official is responsible for assembling the components of the Management Review, as well as any follow-up review deemed necessary by the CEO.

5.6.3 Review Output The CEO is responsible for writing a summary status of the QMS suitability and effectiveness in satisfying the requirements of ISO-9001:2008, the SOR QMS and stated business objectives. This includes special customer requirements and the resource needs of the organization. The resulting re-forecasting of business objectives facilitates improvement of the QMS.

The determination of customer requirements are identified as described in Section 7.2.1. Product improvements made as a result of these requirements are identified in the Management Review in its review of customer feedback and product conformity.

Department leadership identifies the resources and information required to operate and monitor their processes, and have responsibility for the implementation of resources within their departments (ref. Section 4.2.1).

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activity, creating a revised plan. Steps i and ii are then repeated for the revised plan, and monitored (iii) accordingly until another adjustment is deemed necessary. Then the cycle repeats.

The Quality Assurance official is responsible for assuring that trained personnel conduct the annual internal quality audits.

The CEO has created the following positions and has accepted or assigned responsibilities for supporting the quality policy, as follows on the next page (ref. appendices A, B & C for organizational charts).

6.2 Human Resources

6.2.1 GeneralDocumented procedures have been established and are maintained that identify the training needs of personnel performing activities affecting any aspect of the SOR QMS. Personnel performing specific assigned tasks are qualified on the basis of appropriate education, training, skills, and/or experience, as required.

6.2.2 Competence, Awareness and TrainingSOR identifies appropriate qualifications for personnel performing work directly affecting the quality of the product, as part of the annual planning process described in Section 4.1 of this Quality Manual. The qualification of any employee must be specified as described in Section 6.2.1 of this Quality Manual.

SOR takes steps to ensure that our personnel are qualified for performing work affecting product quality. Human Resources works with the other department leadership to ensure that SOR processes are carried out by qualified operators in all jobs related to the manufacturing of the product, installation of the product, or servicing of the product. Effectiveness of training is ensured by test, evaluation forms, or performance reviews, where applicable. Processes are continuously monitored to ensure that the required results are met. All employees at SOR are made aware of the importance their part in the QMS (ref. Section 5.5.3) and are encouraged to use the system (ref. Section 5.5.1).

6.1 Provision of Resources

As part of the annual planning process described in Section 4.1 of this Quality Manual, SOR executives identify the resource requirements of current plans and objectives, including QMS objectives, and take steps to ensure that all plans and objectives have adequate resources for implementation and maintenance.

The SOR Quality Policy, We Deliver Quality On Time, implies a company-wide dedication to the enhancing of customer relationships by understanding and meeting customer requirements. SOR identifies and provides resources for proper implementation, maintenance, and continual improvement of the QMS, and for business objectives that support the Quality Policy.

The CEO is responsible for an organizational structure that supports the business objectives and provides leadership for each department. Human Resources maintains SOR organizational charts. Department leadership identifies resource requirements and has responsibility for the implementation of resources within the department. This includes:

i. Identifying resource requirements for expected production levels, manpower and capacity assumptions, and relevant business objectives as reflected in the annual plan (ref. Section 4.1).

ii. Creating job descriptions that define the responsibilities and authorities of each employee, and the assignment of trained personnel to management, performance, and verification activities (ref. Section 6.2).

iii. Monitoring and reporting on a current basis actual activity vs. expectations in terms of quality, business and financial performance. Sources of analysis include trend data, planning budgets, sales projections, a review of open positions, and any other pertinent information regarding the planning or execution of business plans.

iv. Adjustments to projections are made based upon this review

6.0 Resource Management All procedures referenced in Appendix E.

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SOR documents procedures covering areas pertaining to quality of production, installation, or servicing of all SOR products. The Human Resources Department maintains appropriate documentation, as described in Section 4 of this Quality Manual.

6.3 Infrastructure

SOR identifies and provides for resources needed to accomplish the plans and objectives of the business as part of the annual planning process described in Section 4.1 of this Quality Manual. SOR takes steps to ensure that the business infrastructure is maintained as necessary to achieve the objectives of the business. These steps include:

i. Providing suitable equipment, as described in paragraph v. below, and a suitable work space, associated utilities, and environment, as

described in 6.4.

ii. Machine Shop equipment such as lathes, grinders, presses, and milling machines are monitored by implementing statistical techniques. Welding equipment capability is verified via a qualified welding system in compliance with ASME section IX & AWS D2.1, visual inspection, hydrostatic tests, and additional examinations and inspections when specified.

iii. SOR personnel monitor the process and quality of the results and are supported by Quality department personnel. Test procedures exist to verify that acceptable product characteristics are displayed during the manufacturing process.

iv. Assembly equipment and processes are specified by Manufacturing Engineering. Their capability is verified when the assembly and completed product are checked by the calibration of each final product. The final calibration is performed on gauges whose calibration is traceable to the National Institute of Standards and Technology (NIST).

v. Department Managers are responsible for maintaining tools and equipment in order to satisfactorily produce products that meet specified engineering performance criteria.

6.4 Work Environment

The SOR business is built on the relationships between our employees, our Agents, and our customers. This company promotes the values of teamwork and collaboration, a customer-focused mindset throughout the organization, and a general dedication to business excellence. (ref. Overview).

SOR makes it every managers job to ensure that the organization supports a suitable work environment needed to achieve the objectives of the business. Resource requirements are identified as part of the annual planning process described in Section 4.1.

The requirements for any qualification of process operation, people, or equipment must be specified as described in Section 6.2.1 of this Quality Manual.

The Human Resources Department maintains appropriate training documentation, as described in Section 4 of this Quality Manual.

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7.2 Customer-related Processes

7.2.1 Determination of Requirements Related to the ProductSOR has established and maintains documented processes for determining the requirements of any order quoted or accepted by the company.

This includes the determination of statutory and regulatory requirements related to the product, or other requirements known by SOR but not directly requested by the customer that may be necessary for specified or general intended use of the product.

This also includes requirements specified by the customer, including requirements for delivery and/or post-delivery activities.

7.2.2 Review of Requirements Related to the ProductBefore acceptance of and/or commitment to a contract or order tender, SOR reviews all requirements of the order (ref. Section 7.2.1) to validate the adequate definition and documentation of product requirements, and to resolve any discrepancies between previously understood requirements communicated to SOR and the requirements as called out in the actual order.

The output of this process is generally a product designator that represents a configured product that matches the product requirements, and helps ensure the ability of SOR to meet the defined requirements of the product. In many cases with orders at SOR, there is no documented statement of requirement from the customer. Many times the customer is an Agent who submits a product designator as an order to the factory. SOR actively works in the field to train our Agents on the proper application of SOR products, and does not require any further information with a qualified order submission from an Agent. In other cases, the customer

7.1 Planning of Product Realization

SOR has planned and developed product realization processes in support of the design and manufacturing, product offerings, and general services. This process is consistent with the QMS, as described in Section 4.1. In consideration of product realization planning, SOR has determined:

i. Suitable quality requirements (ref. Section 4.1) and objectives (ref. Section 5.4.1) for product offerings and general services, including requirements for design control (ref. Section 7.3).

ii. Organizational requirements for processes, documentation, and the provision of resources specific to the SOR product offerings and

general services.

iii. All verification, validation, monitoring, inspection, testing activities, and acceptance criteria specific

to the SOR product offerings and general services for product.

iv. Records needed to provide evidence that the realization processes and resulting product services meet requirements (ref. Section 4.2.4).

The outputs of the Product Realization process are in a form suitable for use by the organization and specified within the QMS.

Quality plans (ref. Section 5.4.2) provide summaries of QMS processes that are affected within a defined scope of a specific product or project, and the resources to be applied. The quality planning process ensures that thoughtful consideration is given to the continuity and relevance of the QMS and other company accepted processes as change is introduced to the business environment.

7.0 Product Realization All procedures referenced in Appendix E.

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has a specific product designator to be replaced, but may have no application information or knowledge. Due to these and other circumstances of order submission, a formal review is impractical for each order. In all cases, customers bear full burden of responsibility for proper specification of their own process requirements. SOR never takes responsibility for confirming the application in any way. Typically, if an order has a product designator of an SOR product that SOR can build to published catalog specifications and warranties, and if shipping and billing information is in order, SOR will deliver that product on time. In cases where product requirements change, upon notification by the customer, customer service ensures that relevant documents are amended and that relevant personnel are made aware of the change in requirements.

Records of order requirement reviews, any subsequent actions taken as a result of the reviews, or other such requirement changes are maintained as described in Section 4.2.4 of this Quality Manual.

7.2.3 Customer CommunicationSOR provides for communication with our Agents and customers in a variety of ways. Catalogs, web site, product application bulletins and other such updates, and customer service phone support all provide avenues of communication with both Agents and customers regarding product information, determination of requirements related to the product (ref. Section 7.2.1), inquiries or amendments to existing orders, and general feedback from the field.

SOR takes a proactive stance with all customer feedback, working to accurately understand the customers perception of SOR quality as a function of the Management Review (ref. Section 5.6). This includes determination of perception and satisfaction of selected customers, the analysis of customer feedback, and the tracking and responses to customer complaints.

7.3 Design and Development

The Engineering Department is responsible for the design, selection or modification of products or components, which are sold by SOR. Compliance with regulatory, statutory, or industry-specific requirements is also the responsibility of the department. The department establishes and maintains documentation and records in support of the design activities.

7.3.1 Design and Development PlanningThe Engineering Department prepares plans for all design and development activities. Such plans include definitions of the stages of design and development, the determination of responsibilities and authorities for various design and development activities through the various stages, and the appropriate review, verification, and validation of these stages.

SOR has established cross-functional processes to manage the interfaces between different groups involved in a design or development process. Plans are updated as the design process proceeds. Information is documented and regularly reviewed to ensure effective communication and clear assignment of responsibility.

7.3.2 Design and Development InputsProduct performance criteria, specifications, agency requirements and any statutory or regulatory requirements, information derived from previous experience, and all other elements deemed essential for design and development activities are documented and reviewed by the relevant internal or external parties to ensure that they are non-contradictory and concise.

7.3.3 Design and Development OutputsDesign outputs are documented, defined, and verified against the design inputs. Design outputs shall be provided in a form suitable for verification and meet the requirements of the design inputs and contain or reference acceptance criteria including any characteristics essential to the safe and proper functioning of the design.

Design outputs serve to provide appropriate information for the financial, purchasing, production, and provision of field support.

Design outputs are subjected to review and approval before release.

PRESSUREAPPLICATION

Form 1565 (05.13) SOR Inc.

Application Monitoring the Status of Rupture Discs The Challenge Not all rupture discs are fitted with integral conductors (alarm strips). This means that they are unable to provide indication when a disc ruptures. In critical applications that require protection of pressure vessels from over-pressurization and potentially damaging vacuum conditions, a monitoring and control system must quickly identify a blown disc and provide a visual and audio warning to plant operators. A primary or redundant sensor is required to detect the pressure spike resulting from a blown rupture disc.

The Solution A global chemical company uses an SOR electromechanical pressure

switch called the Mini-Hermet to monitor rupture disc integrity on

equipment throughout their plant in Baton Rouge, Louisiana. Other

pressure switches for this type of application include the Sub Mini-Hermet

for a highly compact switch and the more general Weatherproof Pressure

Switch used in non-explosive conditions.

A pressure switch is placed between a rupture disc and a pressure relief valve. When a disc ruptures, the pressure switch sends a signal to the plants monitoring and control system which warns plant operators.The SOR pressure switch is a calibrated device that can actuate/de-actuate one or more electrical switching element(s) at a predetermined discrete pressure/vacuum set point upon rising or falling pressure/vacuum.

SOR pressure switches can be enclosed in numerous weatherproof and explosion proof housings. Wetted parts on the process connection are available in exotic materials suitable for use with toxic or corrosive process media. SOR electromechanical pressure switches are ideally suited for monitoring the status of rupture discs, also known as bursting discs or burst diaphragms. All switches have a 3-Year warranty.

Pressure Switches

SOR Inc.14685 West 105th StreetLenexa, Kansas 66215

913-888-2630800-676-6794

Fax 913-888-0767

www.sorinc.com

Engineered to Order with Off-the-Shelf Speed

Request a Quote

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7.4 Purchasing

7.4.1 Purchasing ProcessSOR maintains an Approved Vendors List (AVL) system for the purpose of selecting and evaluating vendors on an on-going basis. SOR evaluates and selects suppliers based on their ability to supply product in accordance with SOR requirements. Criteria for the selection, evaluation, and re-evaluation is established, taking into consideration the effect of the purchased component on the final product, verification of material and/or parts by inspection or review of test reports, vendor audits, and historical quality performance data.

The type and extent of control exercised by SOR over a vendor is determined by several factors and defined in the Vendor Agreement and/or purchase order. Materials Management, Engineering and the Quality departments manage a vendor approval and conformance program, corresponding to SOR quality specification standards with vendor qualifications, to ensure that purchased product conforms to specified requirements.

The records or the results of evaluations and any necessary actions arising from the evaluation are maintained as described in Section 4.2.4 of this Quality Manual.

7.4.2 Purchasing InformationThe Materials Management function is responsible for providing a description of the product to be purchased, including requirements for product approval (procedures, processes, equipment), personnel qualifications, and QMS requirements.

Materials Management reviews all purchasing information prior to their communication to a supplier to ensure the adequacy of the requirements.

7.4.3 Verification of Purchased ProductSOR has established and implemented inspection activities for parts and/or materials received against a purchase order, ensuring conformance to specification, work order, or drawings, per the approved receiving inspection procedure.

Where SOR requires verification of purchased product at a vendors premises, SOR will specify verification arrangements and the method of product release in the Vendor Agreement.

7.3.4 Design and Development ReviewAt appropriate stages of the design process, formal, documented review sessions are conducted to evaluate progress against the development plan, identify any problems, and take appropriate action. The occurrence of these review sessions are defined in the planning process (ref. Section 7.3.1), and includes the participants involved in the design process. (ref. Section 4.2 above). Records of the results of verification activities and any necessary actions are maintained as described in Section 4.2.4.

7.3.5 Design and Development VerificationVerification is planned and occurs at appropriate stages of the design process. The verification process ensures that the current stage of the design meets all requirements defined by the design inputs. Records of the results of verification activities and any necessary actions are maintained as described in Section 4.2.4.

7.3.6 Design and Development ValidationValidation activities are performed at appropriate stages of the design process to validate the performance of the product or service in the intended applications, where known. Where possible, validation shall be completed before the delivery of product or market release of a new design.

The process and outcome are reviewed and documented as described in Section 4.2.4 of this Quality Manual.

7.3.7 Control of Design and Development ChangesAll design changes and modifications (including changes involving parts or product already released or implemented) are identified, documented, reviewed, and approved by authorized personnel prior to implementation. The process shall include the evaluation of the effect of changes on products or components previously delivered.

The review of changes and any resulting actions are reviewed and documented as described in Section 4.2.4 of this Quality Manual.P

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Where specified by contract, SOR customers may be afforded the right to verify at the subcontractors premises and/or SOR premises that subcontracted product conforms to specified requirements.

Such verification by the customer shall not be used by the supplier as evidence of effective control of quality by the subcontractor, and shall not absolve SOR of the responsibility to provide acceptable product, or prevent subsequent rejection by the customer.

Inspection may be reduced or even waived if the material is supplied by a qualified vendor that provides inspection reports, such as SPC charts, or otherwise demonstrates that some control is exercised at the subcontractors premises. Unless otherwise noted, inspection is of a sample lot, as described by procedure and/or referenced by any relevant drawings.

If parts are needed for urgent production processing and have not been inspected, they are positively identified as under positive recall and can be recalled immediately in the event of a discovered nonconformance. A sample is kept in the Quality department for inspection. Upon acceptance of the parts, the Quality department incorporates the accepted sample lot into the released lot. Release of parts under positive recall will not preclude any standard inspection activities, which will be carried out as normal.

7.5 Production and Service Provision

7.5.1 Control of Production and Service ProvisionSOR identifies resource requirements and plans production, installation, and servicing processes directly affecting the quality of the product, as part of the annual planning process described in Section 4.1 of this Quality Manual.

SOR takes steps to ensure that our production processes are carried out under controlled conditions. Facilitated conditions include the availability of information describing the characteristics and specifications of the product, the availability of work instructions, the provision of suitable work environments and equipment, including monitoring and measuring processes and equipment, and provisions for delivery and post-delivery service and support activities.

7.5.2 Validation of Processes for Production and Service ProvisionWhen the resulting output of a production and service provision process cannot be verified by conventional monitoring or measurement, SOR will validate the process. The purpose of the validation is to demonstrate the ability of the process to achieve planned results. This includes circumstances where deficiencies become apparent only after the product is in use or the service has been delivered.

SOR has established validation processes, including, as applicable, criteria for review and validation of the processes, approval of equipment and qualification of personnel, use of specific methods and procedures, revalidation, and requirements for records (ref. Section 4.2.4).

7.5.3 Identification and TraceabilitySOR has established and maintains a documented process for identifying parts and finished goods by suitable means from the time of receipt, through all stages of product realization, through to delivery and installation. The inspection and test status of a SOR product is identified by markings in the form of color codes, inspection identification marks, tags, and labels. Identification of parts and assemblies are maintained throughout the manufacturing, assembly, testing, and calibration process, including inspection and test data, as described in Section 8 of this Quality Manual.

When traceability is required by the customer, permanent markings in the form of color codes, heat codes, inspection identifying marks and tags/labels are all used to provide identification for applicable parts. SOR provides traceability on wetted parts* only, through material test reports or certificates of conformance on the raw materials used in the part construction. Traceability is maintained throughout the entire manufacturing, assembly, testing, and calibration process.

*The parts that come in contact with the customers processes.

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7.5.4 Customer PropertySOR exercises care with customer property (including intellectual property while it is under SOR control or being used by the organization). SOR maintains procedures for the identification, handling, storage, and verification of all material or product components that are supplied by SOR customers to be used on or with the products SOR supplies back to said customer, or related activities.

Acceptable product is required for all contracts or orders. Any verification of acceptability by SOR does not absolve the customer of the responsibility to provide acceptable product. SOR provides notification to the customer if supplied product is lost, damaged, or otherwise unsuitable for use.

7.5.5 Preservation of ProductSOR has established and maintains handling procedures that work to ensure proper preservation of the conformity of the product during internal processing and delivery of the finished good. Proper preservation includes identification, handling, packaging, storage and protection, and applies to the constituent parts of a product or the finished good. The condition of materials that have a specified shelf life will be assessed at appropriate intervals.

Shipping personnel verify that a shipment leaving SOR conforms to all packing and marking processes, as outlined by procedure.

All SOR products are handled and packaged in a manner that adequately protects the product after final testing and calibration. This protection is integral to the proper functioning of the product, and is designed to extend through to the end destination and installation of the product.

7.6 Control of Monitoringand Measuring Devices

SOR has established and maintains documented procedures for the control, calibration, and maintenance of all of the inspection, measuring and testing equipment used to check the conformance of parts or product performance to its specifications. Inspection, measurement, and accuracy criteria are specified in product design as described in Section 7.2.1 of this Quality Manual.

When selecting equipment, the Quality department verifies the precision of the equipment is capable of the tolerance criteria of the design specifications. The Quality department works with Manufacturing to ensure that SOR inspection, measuring, and test equipment is used in an appropriate fashion consistent with its monitoring and measuring requirements, taking into account any inherent limitations of the test equipment, in view of the specified requirements of the process.

Any testing software or comparative references such as test hardware used for inspection are subject to monitoring at prescribed intervals to fundamentally ensure the ability to verify, and are rechecked at prescribed intervals. All test equipment affecting product quality is calibrated and/or adjusted at prescribed intervals or prior to use. The ability of computer software to satisfy intended monitoring and measurement applications is confirmed prior to initial use and reconfirmed as necessary.

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Calibration status is marked on all test equipment when practical, or on the equipment storage container, when necessary, to allow its calibration status to be determined. When practical, equipment numbers are engraved on gauges and test equipment is suitably identified. Calibration data is maintained for each piece of measuring and test equipment. This data includes the equipment number, calibration period, calibration method description, location, custodian, acceptance requirement, and (if available) manufacturer serial number.

The Quality department is responsible for safeguarding test facilities during use and calibration, including test hardware and software, to ensure that the accuracy and fitness for use are preserved. Precautions are taken against inadvertent adjustments to equipment that would invalidate test results, including circumstances arising from shipping, handling, maintenance, or storage activities.

Procedures are maintained that define the process employed for the calibration of inspection, measuring, and test equipment. These procedures include details of equipment type, unique identification, location, frequency of checks, check method, acceptance criteria, and the subsequent requirement for a Non-Conformance Report (NCR) when calibration results are not in conformance with specifications.

When calibrating equipment, the Quality department shall ensure that the environmental conditions are suitable for the calibration, inspection, measurements, and tests being carried out. Calibrations are performed using certified equipment having a known valid relationship to internationally or nationally recognized standards. Where no such standards exist, the basis used for calibration shall be documented in a relevant quality plan.

If calibration results are unsatisfactory, the Quality Assurance official is notified by the NCR. Corrective action is taken, including consideration of recall for any items that were inspected by the deficient gauge.

If the availability of technical support data pertaining to inspection, measuring, and test equipment is a customer requirement, such data may be made available to the customer or customers Agent by SOR for validation that the equipment is functionally adequate.

Records of the results of calibration and verification are kept as described in Section 4.2.4 of this Quality Manual.

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8.2.2 Internal AuditSOR conducts a comprehensive set of planned and documented audits to determine the effectiveness of the QMS. Internal audits verify the implementation of the QMS. They verify that activities and related results conform to the planned arrangements of both the ISO 9001:2008 Standard and the requirements of the SOR business plan. Audits also verify that the QMS is maintained effectively through continuous improvements.

Responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records are defined in documented procedures. An audit schedule is planned and maintained by the Quality Assurance official, taking into consideration factors relating to the status and importance of the processes and areas to be audited, including the results of previous audits. The audit schedule defines the criteria, scope, frequency, and methods used in each audit. At SOR, internal audits of the QMS are performed annually. If for some reason it is determined that additional audits are required, the Quality Assurance official modifies the audit schedule accordingly.

Care is taken in the selection of auditors and the conduct of audits to protect objectivity and impartiality. Assigned auditors are to have no direct job responsibility in the area of the audit. In the words of the ISO Standard: Auditors shall not audit their own work.

Audit results are documented and forwarded to management personnel having responsibility for the area audited. The responsible management assures that timely corrective action is taken on deficiencies found during the audits. Follow-up activities record the implementation and verify the effectiveness of the corrective action taken.

Audit reports and supporting documentation are retained as quality records as described in Section 4.2.4 of this Quality Manual.

8.1 General

SOR has planned and implemented quality plans and procedures for monitoring, measurement, and analysis activities. These activities demonstrate that all product specifications key to the quality of the parts, assemblies, and finished products are met. The activities also ensure conformity to the QMS, and continual improvement of the effectiveness of the system. Quality plans and procedures state what inspection, testing, and record keeping is required.

Documented procedures have been established and are maintained to implement and control the application of statistical techniques within SOR. Methods include the use of statistical techniques for monitoring and controlling processes.

Statistical techniques are used for inspection of incoming parts, in process inspection and final product inspection. Statistical techniques may also be employed to reduce the requirement for frequent inspections during a production process, once the process has been proven to be under control.

The in-house verification requirements of the SOR QMS are identified within the Quality department organization chart. All verification activities connected with SOR products are the responsibility of the Quality Assurance official, who is, in turn, directly accountable to the CEO for any product quality or safety considerations.

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction SOR monitors information relating to customer perception as to whether the organization has met customer requirements (ref. Section 5.2).

8.0 Measurement, Analysis and Improvement All procedures referenced in Appendix E.

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8.2.3 Monitoring and Measurement of ProcessesThe SOR QMS relies heavily on the interpretation of process measurement data. Effectiveness of the QMS in supporting planned operational results (ref. Section 5.1 & 5.4), implementing corrective action (ref. Section 8.5.2), and achieving continuous improvement are all supported by the analysis of various metrics that relate to the process controls of finished products, goods, services, and operational support systems.

8.2.4 Monitoring and Measurement of ProductAt SOR, it has been recognized for half a century that an important key performance test of our products is carried out at the calibration stage, just before the product is packaged for delivery. At this point, a verification of the units operational characteristics is performed.

As a matter of the SOR Quality Policy, all specified inspections and tests, including those specified either on receipt of product or in-process, are carried out, and assurances made that the results meet the specified requirements. No SOR product is released for shipment to a customer until all activities specified in the quality plan and/or procedures (ref. Section 7) have been completed and documented.

At the calibration stage, each product is cycled, set, and performance is verified and documented, and released for shipment by authorized personnel. Inspection records show clearly whether the product has passed or failed the inspections according to defined acceptance criteria, and identify the inspection authority responsible for the release of the products. An end-of-line product sampling program subsequently verifies the product requirements are met. If a non-conformance is discovered, it is noted on the inspection record and appropriate action is taken.

Mandatory inspection or hold points, as required by either the customer or the SOR internal QMS, may be incorporated into internal assembly procedures or vendor supply agreements.

All documentation is conducted as described in Section 4.2.4 of this Quality Manual.

8.3 Control Non-Conforming Product

Non-conformances come to the QRB in several ways including:

Acustomer complaint represents a perceived external non-conformance that does not involve the return of product to SOR.

AReturned Material Authorization (RMA) represents a perceived external non-conformance which includes the return of product to SOR.

ANon-Conformance Report (NCR) represents an internal non-conformance.

Internal audit reports identify non-conformances discovered during internal audits.

Rework represents non-conformances requiring corrections during Production.

Scrap represents inventory waste.

Rescheduled Orders identify non-conformance to delivery schedulesand commitments.

Final Inspection identifies non-conformances discovered after final assembly.

Each of these non-conformances are documented as described in Section 4.2.3 of this Quality Manual.

The non-conformance process exists to ensure that any product or service that does not conform to SOR quality standards is identified and controlled, preventing the unintended use or delivery to a customer. An NCR is processed according to a documented procedure, and, among other details, requires notification of the organizational functions concerned. The NCR provides a control for identification, evaluation, and disposition of non-conforming product or process, and documentation and record-keeping of any subsequent actions taken, including concessions obtained from the customer.

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The responsibility for review and authority for the disposition of nonconforming product is defined and documented. Non-conforming product will be reviewed in accordance with the NCR process. The product may be:

i. reworked to meet specified requirements,

ii. accepted with or without repair by concession,

iii. regarded for alternative applications, or

iv. rejected or scrapped.

Any non-conforming material, part, or assembly is identified and controlled until released by the NCR process.

If a non-conformance is detected in any product or service after delivery or use has started, SOR will take actions appropriate to the nature and the potential effects of the non-conformance.

Any non-conforming product identified by an NCR that is determined to need rework or repair is re-inspected to verify its conformance to the SOR QMS.

If deemed appropriate given the nature of the non-conformity, the use of repaired material may be submitted for concession to the customer or his representative.

8.4 Analysis of Data

The QMS relies heavily on the analysis of various metrics that relate to the process controls of finished products, goods, services, and operational support systems (ref. Section 8.2.3). Documented procedures have been established and maintained in order to implement and control the application of process control within SOR.

SOR monitors and measures process metrics of finished goods and services, for establishing the suitability and effectiveness of the QMS, and to determine and evaluate opportunities for continual improvement.

Statistical based sampling is used for inspection of incoming parts, in-process inspection, and final product inspection. Other sources of data provide information relating to customer satisfaction, the conformance of the product to product requirements, process trend data, data supporting opportunities for continual improvement, and supplier relationships.

Statistical based sampling may also be employed to reduce the requirement for frequent inspection of components or products during the production process, once the process is demonstrated to be under control and within the parameters of the Design Control (ref. Section 7.3).

8.5 Improvement

8.5.1 Continual ImprovementThe ultimate objective of the SOR QMS is to foster and focus organizational momentum for continual improvement. It accomplishes this through the use of the Quality Policy, the management review, quality objectives, audits and their results, analysis of data, the non-conformance process, and corrective and preventive actions.

Corrective and preventive actions are initiated by all the processes listed above, and processed by the QRB, as described in Section 8.3 of this Quality Manual. NCRs are processed based upon a consensus of appropriateness, with consideration given to the magnitude of an issue, perceived risks involved, etc.

All actions implemented, and any changes resulting from an action, are documented as described in Section 4.2.3 of this Quality Manual.PR

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8.5.2 Corrective ActionA corrective action is an action designed to eliminate the determined cause of a non-conformance, in order to prevent recurrence. It should be appropriate to the effect of the non-conformance, and SOR has established and maintains documented procedures to define the requirements for:

i. The review and effective handling of reports of non-conformances, including customer complaints and investigations in the field.

ii. The determination of the causes of a non-conformance.

iii. The evaluation of the need for some corrective action to ensure elimination of a

non-conformance.

iv. The determination and effectiveness of appropriate action required to eliminate the

cause of a non-conformance.

v. The records of the results of action taken, documented as described in Section 4.2.3.

vi. The review of a corrective action ensures a non-conformance has been eliminated.

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