Copyright © 2021 Starrett Kinemetric Engineering All rights reserved www.starrettkinemetric.com
April 2021 8063 Revision E
The information contained herein is subject to change without notice. Revisions may be issued to of such changes and/or additions.
Correspondence regarding this publication should be forward to Starrett Kinemetric Engineering by addressing remarks to Technical Support Starrett Kinemetric Engineering, 26052 Merit Circle, Suite 103 Laguna Hills CA 92653, USA. Comments about documentation can also be sent through our service website at: https://www.ske-service.com/service-request.
Starrett Kinemetric Engineering is an ISO 9001:2015 registered company.
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1.0 Revision History and Approval
Rev.
Nature of changes
Approval
Date
Mark Arenal, Donn Silberman Mark Arenal, Donn Silberman Mark Arenal, Donn Silberman
A
Original release.
9/21/18
B
Updates to include ISO consultant comments
11/19/18
Changes references from division of Starrett to subsidiary Includes references to Quality Team, updates to Section 4.0 and included functional organization chart Updated organizational chart, changed references to ISO Program Manager to Quality Program Manager, updated several references to QMS procedures. Removed ISO 17025 scope of certification. Not valid until certification is achieved per supplier quality audit.
C
1/23/19
Mark Arenal
D
3/27/20
Donn Silberman
Mark Arenal, Debbie Donahue
E
4/26/21
2.0 Starrett Kinemetric Engineering Company Information
Company Background
The L.S. Starrett Company, founded in 1880, manufactures more than 5,000 variations of precision tools, gages, and measuring instruments for industrial, professional and consumer markets worldwide. Starrett, a leader who has set the standard for fine precision tools in industry for over 130 years, has rightfully earned the title, "World's Greatest Toolmakers". Starrett Kinemetric Engineering Located in Laguna Hills California, Starrett Kinemetric Engineering, Inc. (a wholly owned subsidiary) of the L.S. Starrett Company, provides leading edge vision and optical measurement systems. These powerful systems combine high-resolution images, powerful intuitive software and precision mechanical platforms to deliver superb accuracy and repeatable measurement results. Starrett Kinemetric Engineering employs an integrated approach to comparator and metrology technology that includes state-of-the art systems, custom application development and highly trained technicians. From aerospace to medical device manufacturing, Starrett Kinemetric is the choice of industry leaders looking to maximize productivity, accuracy, and capabilities. 3.0 Quality Policy Starrett Kinemetric Engineering, Inc. (SKE) has developed the following Quality Policy which governs day-to-day operations to ensure quality. The Quality Policy is communicated and implemented throughout the organization.
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Starrett Kinemetric Engineering (SKE) strives to deliver the products and services that meet the customer’s requirements. SKE is committed to constant impro vement by training its people, upgrading equipment, eliminating non-essential practices, and creating an environment of total quality consciousness. SKE ensures that this quality policy is understood, communicated, implemented, reviewed and maintained at all levels of the organization to ensure continuing suitability. No product or service offered to a customer contains a known condition inconsistent with applicable contract requirements or advertised specifications. This Quality Policy is reviewed regularly and updated if required to ensure all quality objectives are met. The policy is communicated to SKE employees through the Introduction to ISO9001 training module. This training module is available in the QT9 software. The Quality Policy is
communicated to other interested parties upon request. SKE is committed to meet the following requirements:
Customer
• • • • •
ISO 9001: 2015 ISO 17025:2017
Regulatory
Statutory
4.0 SKE Organization The functional organizational chart illustrated below provides the core departments that comprise the SKE organization. The table below briefly describes each position.
Function
Department
Description
General Manager
Starrett Kinemetric Engineering
Senior executive responsible for managing both financial and day-to-day operations of all Starrett Kinemetric Engineering (SKE) departments. Reports to VP of Metrology. Ensures financial operations are performed with timeliness, accuracy, and relevance. Responsible for leading, supervising, and planning the activities, personnel and equipment
Finance Director Materials Manager
Finance
Materials Management
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Function
Department
Description
involved in materials management, including the multiple functions of material planning, procurement/purchasing, machining, warehousing, inventory control, shipping and receiving.
Technical Services Manager
Technical Services Lead the Technical Services Team to provide excellent customer service experience in the areas of system installation, calibration, repairs, retrofits and training.
Production Manager - Vision
Vision Production
Coordinate, lead and perform the activities involved in assembling, testing, calibrating and crating SKE Vision Metrology Systems in accordance with customer requirements, system assembly procedures and the production schedule.
Production Team Leader – Optical
Optical Production Support SKEs Optical Comparator department in accordance with customer orders and the production schedule for new machines and parts orders, as well as assisting in the machine shop and parts pickup and delivery.
Engineering Manager
Engineering
Lead the Engineering Department to design, develop, solve, implement, document and refine SKEs products to meet customer requirements. Lead the team of Inside Sales Coordinators to ensure timely and accurate coordination, recording, and monitoring of the activities from customer quotation to customer invoice. Lead the team of Product Sales Specialist to sell SKE Metrology Products (Optical Comparators, Vision Systems, other products and services as designated) to distributors or end users. Responsible for the SKE quality management system (QMS), ISO quality-related training, and oversight of the Quality Team.
General Manager
Inside Sales
Sales Director
Sales
Quality Program Manager
Not applicable
5.0 SKE Quality Team The SKE Quality Team is comprised the of the following core members: Finance Director, Materials Manager, Engineering Manager, Technical Services Manager and Production Manager. The team is facilitated by the Quality Program Manager. The team meets on a quarterly basis (or more frequently as business demands warrant) and discusses key activities in the QMS. Topics can include the following:
• Nonconforming products and services
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Supplier issues and review
• • •
Calibration metrics
Results of internal audits
• Any other quality-related issues that impact the organization 6.0 Scope of the SKE Quality Management System
The purpose of this manual is to describe the Quality Management System (QMS) implemented by SKE. The manual serves as the primary reference document for controlling quality-related activities. Additional QMS documented procedures have been developed to support the QMS and its processes. All necessary QMS documentation is available in the QT9 software. The scope of the QMS covers the manufacture and service of vision and optical metrology products that serve the machine tool, optical, electronic, automotive, medical device, aerospace, metrology, and motion control industries. Based on an analysis of the above issues of concern, interests of stakeholders, and in consideration of its products and services, SKE has determined the scope of the certification is as follows: The scope of ISO 9001:2015 certification covers the design, development, manufacture and service of custom and standard optical and video-based metrology systems, coordinate positioning platforms, and precision motion devices that service a variety of industries including machine tools, aerospace, and medical device manufacturing. SKE uses the quality manual for planning, implementing, coordinating, and assessing our quality management system. This manual is made available to our customers when requested. This quality manual must not be reproduced in whole or part without the prior consent of the Quality Program Manager or General Manager. It is designed to be used by both internal and external audit teams during the assessment of our QMS. The quality system applies to all processes, activities, and staff within the company. The company claims no exclusions from the ISO 9001. 7.0 QMS Processes SKE has adopted a process approach for its management system. By identifying the processes within the company, and then managing each of these discretely, this reduces the potential for nonconforming products or services discovered during final processes or after delivery. Instead, nonconformities and risks are identified in real time, by actions taken within each of the processes. The following high-level functions have been identified for SKE:
Management and operations Business development and sales
• • • • • • •
Purchasing and receiving Design and development
Production
Field service/technical support
Calibration
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The following information provides a mapping of the high-level function, applicable ISO procedure and corresponding ISO clause. A comprehensive list of ISO documents is stored in the QT9 software. 7.1 Management and Operations
Applicable ISO 9001:2015 Clauses
Applicable ISO/IEC 17025: 2017 Clauses
ISO Procedure
5.0 Structural Requirements
SKE Scope of Calibration
4.0 Context of the Organization
SKE Procedure Context of the Organization SKE Procedure Context of the Organization
5.0 Leadership
6.0 Planning
SKE Procedure Management Review SKE Procedure Risk and Opportunity Management
•
•
SKE Procedure Change Management
•
7.0 Support
6.2 Personnel
SKE Procedure Competence and Awareness SKE Procedure Calibration of Product SKE Procedure Equipment Validation SKE Procedure Preventive Maintenance SKE Procedure Control of Documents SKE Procedure Control of Records SKE Procedure Outsourced Processes SKE Procedure Design and Development of Products and Services
•
6.3 Facilities and Environmental Conditions
•
•
6.4 Equipment
6.5 Metrological Traceability
•
7.5 Documentation
7.11 Control of data and information management
•
•
7.5 Technical records
8.4 Control of records
8.1 Operational planning and control
7.0 Process requirements
•
•
SKE Procedure Change Management
•
9.0 Performance evaluation
7.9 Complaints
SKE Procedure Competence and Awareness SKE Procedure Risk and Opportunity Management SKE Procedure Customer Satisfaction
•
8.5 Actions to address risks and opportunities
•
•
9.2 Internal audits
8.8 Internal audits
SKE Procedure Internal
•
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Applicable ISO 9001:2015 Clauses
Applicable ISO/IEC 17025: 2017 Clauses
ISO Procedure
Audits
9.3 Management review
8.9 Management reviews
SKE Procedure Management Review SKE Procedure Corrective and Preventive Action SKE Procedure Customer Satisfaction SKE Procedure Calibration of Product
•
10.0 Improvement
8.6 Improvement
•
•
4.1 Impartiality
•
4.2 Confidentiality
SKE Calibration Policy
•
7.2 Business Development and Sales
Applicable ISO 9001:2015 Clauses 8.2 Requirements for products and services
Applicable ISO/IEC 17025: 2017 Clauses 7.1 Review of requests, tenders, and contracts
ISO Procedure
SKE Procedure Quoting and Ordering Acceptance
•
SKE Procedure Managing Custom Product and Service Requests
•
SKE Procedure Outsourced Processes
•
7.3 Design and Development
Applicable ISO 9001:2015 Clauses 8.3 Design and development of products and services
Applicable ISO/IEC 17025: 2017 Clauses 7.2 Selection, verification, and validation of methods
ISO Procedure
SKE Procedure Design and Development of Products and Services SKE Procedure Managing Custom Product and Service Requests SKE Procedure Bill of Materials SKE Procedure Engineering Change Request (ECR) and Engineering Change Notice (ECN)
•
•
• •
SKE Procedure Bill of Materials
•
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7.4 Purchasing and Receiving
Applicable ISO 9001:2015 Clauses 8.4 Control of externally provided processes, products, and services
Applicable ISO/IEC 17025: 2017 Clauses
ISO Procedure
6.6 Externally provided products and services
SKE Procedure Materials Management SKE Procedure Inventory Management SKE Procedure Receiving Inspection SKE Procedure Control of Third-Party Property SKE Procedure Bill of Materials SKE Procedure Preservation of Product SKE Procedure Outsourced Processes SKE Procedure Shipping
•
•
•
•
•
•
•
•
7.5 Production
Applicable ISO 9001:2015 Clauses 8.5 Production and service provision
Applicable ISO/IEC 17025: 2017 Clauses
ISO Procedure
SKE Procedure Production of Vision Products SKE Procedure Production of Optical Products SKE Procedure Control of Third-Party Property
•
•
8.6 Release of products
•
SKE Procedure Identification and Traceability
•
SKE Procedure Calibration SKE Procedure Equipment Validation SKE Procedure Preservation of Product SKE Procedure Preventive Maintenance
•
•
•
•
•
SKE Procedure Shipping
8.7 Control of nonconforming outputs
7.10 Nonconforming work
SKE Procedure Nonconforming Service SKE Procedure Nonconforming Product Pre/Post Delivery
•
•
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7.6 Field Service
Applicable ISO 9001:2015 Clauses 8.5 Production and service provision 8.6 Release of products and services 8.7 Control of nonconforming outputs
Applicable ISO/IEC 17025: 2017 Clauses
ISO Procedure
•
SKE Procedure Technical Services
7.10 Nonconforming work
SKE Procedure Nonconforming Service SKE Procedure Nonconforming Product Postdelivery
•
•
7.7 Calibration
Applicable ISO 9001:2015 Clauses 7.1.5 Monitoring and Measuring and Resources
Applicable ISO/IEC 17025: 2017 Clauses
ISO Procedure
7.3 Sampling
SKE Procedure Calibration of Product SKE Procedure Equipment Validation System-specific calibration procedures
•
7.4 Handling of test or calibration items
•
7.6 Evaluation of measurement uncertainty 7.7 Ensuring the validity of results
•
7.8 Reporting the results
8.5 Production and service provision
7.5 Technical records
SKE Procedure Identification and Traceability
•
SKE Procedure Control of Records
•
Each process may be supported by other activities, such as skill sets, tasks, or work instructions. Each QMS procedure includes the following information:
Procedure owner(s)
•
• Impacted ISO 9001 and/or ISO 17025 clauses • Revision control information • Applicable terminology • Applicable responsibilities and authorities • Critical and supporting company resources The sequence of interaction of these processes is illustrated in Appendix A.
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Throughout the year, metrics data is measured and gathered by process owners or other assigned managers so that the data can be presented to the General Manager and Quality Team. The data is then analyzed by the Quality Team so that the General Manager and Quality Team can set goals and make adjustments for the purposes of long-term continual improvement. Metrics, along with current standings and goals for each objective, are recorded in the Management Review module in the QT9 software and is controlled under the SKE Procedure Management Review . When a process does not meet a goal, or an unexpected problem is encountered with a process, the corrective and preventive action process is implemented to research and resolve the issue. In addition, opportunities for improvement are sought and implemented, for the identified processes. Any process performed by a th ird party is considered an “outsourced process” and is controlled under the SKE Procedure Outsourced Processes .
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8.0 Documentation Requirements
General
SKE has documented procedures as required to implement an ISO 9001:2015 and ISO/IEC 17025: 2017 quality management system. We maintain the documented procedures necessary to ensure the effective operation and control of our processes. SKE ensures that all employees have access to QMS documentation and are aware of relevant procedures. Customer representatives also have access to QMS documentation upon request. Quality Manual SKE will operate a QMS that is based upon policies and procedures that are documented and controlled. Two diagrams describing the interaction between SKEs QMS processes are included in this manual (see Appendix A). The interrelationships of our processes are also described in other process maps, operating procedures, and work instructions. The SKE management team is responsible for establishing an effective QMS. It is the responsibility of all SKE employees to familiarize themselves with QMS requirements and to ensure that they are observed while performing their jobs and during audits. Control of Documents and Information Documentation and records used to control the quality of SKEs products and services, from the quote process and the receipt of customer orders through fulfillment of those orders to the customer’s destination, are controlled. The operating procedures forming the QMS are also controlled. SKE uses four primary mechanisms to control information:
SAP Sales Cloud software This software provides the sales team with the quoting platform for products and services.
•
• Number Cruncher/Quick Books software This software primarily controls inventory management, quoting (for service only), and financial records. • Solid Works Product Data Management (PDM) software This software primarily controls engineering specifications, drawings, models, internal standards, work instructions, manuals, and technical bulletins.
QT9 Quality Management Software This software controls all ISO-related documents, procedures, work instructions, calibration records, and training records. Zendesk software Customer service software that enables the SKE Technical Services team to track, monitor, and respond to customer support requests.
•
•
SKEs Quality Program Manager is responsible for maintaining the documentation control system. A list of controlled documents is maintained in the QT9 quality management software. It is the responsibility of all company personnel originating, acquiring, or amending any process or material within the scope of controlled documentation to ensure that such activities are recorded in accordance with the appropriate procedures.
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Appendix A: Overall Process Sequence and Interaction
SKE Quality Management System
Management Responsibility
Corrective and Preventive Action
Quality Planning
Resource Management
Quality Auditing
Input
Process Control/ Product Realization
Output
Customer Requirements Received
Customer Product/Order Shipped Service Delivered
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