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Sentry Equipment Corp.QUALITY MANAGEMENT SYSTEM MANUAL

QA 100.04 Revision 16

January 23,2015

966 Blue Ribbon Circle NorthOconomowoc, Wisconsin 53066

Phone: 262-567-7256Fax: 262-567-4523

References:

ISO 9001:2008

For products manufactured in accordance with ASME Boiler and Pressure Vessel CodeSection Vlll, Division 1, for Vessels Stamped with "U" Construction Code Designator

APPROVALS

l-zs- lsQuality nager Date

President & CEO Date

ACCEPTED BY

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FOR REFERENCE ONLY. COPY IS NOT CONTROLLED.

Revision 16 page 1 of 394

1.0 Control of the Quality Management System (QMS) Manual (Manual) The Sentry Equipment Corp. (Sentry Equipment / Sentry Equip. / Sentry) Quality Management System (QMS) Manual (Manual) shall document the quality practices used to assure that items manufactured by Sentry Equipment Corp. conform to standards of quality that meet the requirements of the Contract specifications. As applicable, this includes the ASME Code. This Manual provides for and describes the procedures used to assure that:

1. Activities affecting quality are accomplished and documented in accordance with written instructions, procedures and drawings.

2. Activities affecting quality are accomplished under suitably controlled conditions, including the use of appropriate equipment, suitable environmental conditions, and with assurance that prerequisites for the given activity have been satisfied.

3. Special controls, processes, test equipment, tools and skills are employed as appropriate to attain the required quality.

4. The required quality level is verified by inspection and test. 5. Nonconforming materials and items are readily detected and that timely and positive

corrective actions are instituted. 6. Qualitative and quantitative acceptance criteria shall be enforced to assure that

prescribed activities are satisfactorily completed.

MANUAL REVISIONS

Revisions to this Manual shall be made for the entire Manual and listed in revision history. All revisions of the Manual shall be approved by the Quality Manager, the President and accepted by Authorized Inspector. The Quality Manager will review this Manual as appropriate and be held responsible for updating and maintaining the Manual prior to the mandatory effective date of the new ASME Code Edition. Upon accepting the new ASME Code Edition, the Summary of Changes page of will be initialed and dated. MANUAL DISTRIBUTION

The Quality Manager shall assure that controlled read only copies of the Manual are maintained in electronic format and placed onto the company’s Internet and Intranet. The Quality Manager will provide access to the company’s Intranet to the Authorized Inspector and Sentry personnel who are responsible for the implementation of this program. The company’s Internet address will be provided to organizations that request controlled Copies of the Manual.

Individuals that require a hard copy of the Manual will receive an uncontrolled for

reference only version of the Manual. The Quality Manager will notify organizations requesting notification of Manual

changes by correspondence using the Notification Letter Quality Manual Control (see Exhibit 1 in Appendix). This correspondence shall state that in order to maintain notification status, acknowledgment of the notification must occur within 10 days.



TABLE OF CONTENTS START

SECTION PAGE GENERAL 1.0 Control of the Quality Management System (QMS) 1

Table of Contents 2 Revision History 3 Cross Reference of QMS to ISO 9001:2008 Requirements 4

SCOPE and Responsibility and Authority 2.0 6 QUALITY POLICY 3.0 7 QUALITY MANAGEMENT SYSTEM 4.0 8

General Requirements 8 Documentation Requirements 9

MANAGEMENT RESPONSIBILITY 5.0 11 Management Commitment 11 Customer Focus 12 Quality Policy 12 Planning 12 Responsibility, Authority and Communication 13 Management Review 13

RESOURCE MANAGEMENT 6.0 17 Provision of Resources 17 Overall Awareness of the QMS 17 Competence and Training Responsibility and Records 17 Infrastructure 18 Work Environment 18

PRODUCT REALIZATION 7.0 19 Overview of product Planning Controls 19 Customer-Related Processes 19 Design and Development 20 Purchasing and Materials Control 24 Production and Service Provision General Requirements 25 Identification and Traceability, including Customer Property 26 Examination and Inspection 27 Welding Control 28 Nondestructive Examination (NDE) 29 Calibration of Measurement and Test Equipment 29 Handling, Storage and Shipping 30 Servicing 30

MEASUREMENT, ANALYSIS & IMPROVEMENT 8.0 31 General 31



Monitoring and Measurement 31 Control of Nonconforming Product 32 Corrective Action 33 Preventive Action 33

Appendix 9.0 Exhibit 1 – Quality Manual Notification Letter 34

Exhibit 2 - QMS Customer Procedure Reference Table 35

1.3 REVISION HISTORY 0. 2/17/95: initial issue. 1. 10/10/97: compare to revision 0. 2. 6/30/98: compare to revision 1. 3. 3/26/01: added “Revision History” to Table of Contents, updated Section 1A, changes to Sections 1 and

3; titles of employees changed throughout the manual to conform to the Organizational Chart (Section 1A).

4. 3/17/03: updated Section 1A; revised Section 2, revised Section 4, revised Section 12, added Section 15, “Training”; added Section 16 “Customer Supplied Products and/or Services”; revised and added to “Exhibit Forms”, Section 17 (“Exhibit Forms” was Section 15 in revision 3 of manual).

5. 6/15/06: added CAR requirement at customer’s request. 6. 6/15/07: revisions to sections 1.0, 1A, 2.0, 3.0, 4.0, 5.0, 6.0, 10.0, 11.0, 17.0, and table of contents.

Eliminated section revisions and replaced with total document revision. Section 5 totally revised to comply with new nonconformance system. Exhibits revised to comply with new nonconformance system. Rename Quality Assurance department to Quality department.

7. 3/9/2009: revise to include requirements of ISO 9001:2000. Where appropriate, combine requirements for ASME Code and ISO 9001:2000. Remove ASME procedures to separate procedures where required.

8. 3/14/2009: revise and include additional references within manual. Replace ISO 9001:2000 with ISO 9001:2008. Clerical corrections where needed.

9. 8/10/2009: revise section 6.1.4 remove “ training period has elapsed” replace with “after training and training will be repeated as necessary. Added Authorized Inspector (A.I.) duties sections (7.3.9.1 – 7.3.9.11). Added reference procedure 22-09208A for ASME design and development.

10. 7/22/2010: Updated organizational chart, corrected table of contents and cross reference table to reflect correct page location within quality manual. Added additional information to ISO cross reference table. Added Customer/QMS reference table to appendix.

11. 1/21/2011: Updated organizational chart. 12. 9/22/2011 Update delegate additions sec 7.8.3 & 7.8.4, update Org. Chart, update Process Flow

Diagram (Figure 2.0) 13. 1/11/2012 Editorial updates throughout manual. 14. 1/26/2012 Editorial updates throughout manual. 15. 1/9/15 Under “U” designation replaced “symbol” with “Construction Code Designator” throughout manual,

removed “UM” Symbol reference throughout manual, updated QMS and Manual references throughout, removed gender specific references throughout, updated sec. 1.0 to include “Upon accepting the new



ASME Code Edition, the Summary of Changes page of will be initialed and dated”, updated President and CEO, updated Org. Chart, replaced “Shop Supervisor” with “Production Manager” throughout manual, updated Business Unit Manager definition in sec. 7.2.1, updated sec. 7.2.5 to VP Power or Process or designee from Customer Service, updated sec. 7.2.6 to remove “Administrator”, removed second paragraph from sec. 7.3.9.2 because it is already stated in sec. 7.3.9.3, replaced “Inside Sales Manager” with “Applications Engineer” in sec. 7.2.6.4 and 7.2.6.5, replaced “Manufacturing Services Manager” with “Materials Manager” in sec. 7.4.2.3, removed sec. 7.7.1.1 and 7.7.1.2 because they specifically pertained to UM Vessels, updated sec. 7.7.4.2 and 7.7.4.3 to more clearly state inspections by Assembly and Quality, updated sec. 7.7 to change “Quality Inspector” to “QA Inspector”, updated sec. 7.7.2 and 7.8.2 to clarify “Engineering” titles, replaced “Business Unit Manager” to VP Power or VP Process throughout manual, added “Chief Technology Officer” title to section 7.3, minimized the use of “or designee” throughout the manual.

16. 1/23/15: Added reference to “Section 5” in section 4.1.1, updated second sentence in section 4.1.8 so

it’s grammatically correct, added “of this manual” to section 5.3.1, updated Org. Chart, replace “associate” with “employee” in section 6.3.3, replaced “ERP” with “Materials Requirements Planning (MRP)” in section 7.2.6, replaced “project lead, or designee” with “Engineer (Product Engineer, Design Engineer or designee)” in section 7.3.4.2, added “(7.12 of this Manual)” to section 7.3.7.2, added “Return Materials Authorization” to section 7.6.4.1, added “QA” to section 7.7.3, replaced “supervisor” with “Weld Supervisor (Weld Team Leader or Work Cell Team Leader)” in section 7.8.3, replaced “Parts and Service Manager” with “Director Aftermarket Parts & Service or Product Support Supervisor” in section 7.12.3, replaced “Servicing personnel” with “Service Technicians” in section 7.12.3.1, replaced “quality function” with “Quality Manager” in section 8.4.4.



1.4 Cross Reference: Sentry Equipment Corp.’s Quality Management System

Manual and Documented Procedures to Comply with Requirements of ISO 9001:2008 and ASME Boiler and Pressure Vessel Code Section VIII, Division 1

Procedures Reference Table

ISO 9001:2008 Cross-Reference

Description Manual Section

ISO 9001:2008 Procedure Reference

ASME Procedure Reference

4 Quality Management system 4.0 4.1 General Requirements 4.1 4.2 Documentation Requirements 4.2

4.2.1 General 4.2 4.2.2 Quality Manual 4.2 4.2.3 Control of Documents 4.2 18-09209A 22-09206A 4.2.4 Control of Records 4.2 18-09210A 22-09206A

5 Management Responsibilities 5.0

5.1 Management Commitment 5.1

5.2 Customer Focus 5.2 5.3 Quality Policy 5.3 5.4 Planning 5.4

5.4.1 Quality Objectives 5.4 5.4.2 Quality Mgmt. System Planning 5.4 5.5 Responsibility, Authority, and

Communication 5.5

5.5.1 Responsibility and Authority 5.5 5.5.2 Management Representative 5.5 5.5.3 Internal Communication 5.5 5.6 Management Review 5.6

5.6.1 General 5.6 5.6.2 Review Input 5.6 5.6.3 Review Output 5.6

6 Resource Management 6.0 6.1 Provisions of Resources 6.1 6.2 Awareness of QMS 6.2

6.2.1 Employee communication 6.2 6.2.2 Competency, Awareness and Training 6.3

6.3 Infrastructure 6.4 6.4 Work Environment 6.4.1 7 Product Realization 7.0

7.1 Planning of Product Realization 7.1 7.2 Customer-Related Processes 7.2

7.2.1 Determination of Requirements related to the Product

7.2

Sentry Equipment Corp.



7.2.2 Review of Requirements Related to

the Product 7.2

7.2.3 Customer Communication 7.2 7.3 Design and Development 7.3 18-09007A 22-09208A

7.3.1 Design and Development Overview 7.3 7.3.2 Design and Development Planning 7.3

7.3.3 Design and Development Inputs 7.3 7.3.4 Design and Development Review 7.3 7.3.5 Design and Development Verification 7.3 7.3.6 Design and Development Validation 7.3 7.3.7 Design and Development Changes 7.3 7.3.8 Design and Development Outputs 7.3 7.3.9 Inspection by 3rd Party 7.3

7.3.10 Release to Manufacture 7.3 7.4 Purchasing and Materials Control 7.4 22-09207A

7.4.1 Purchasing Process 7.4 7.4.2 Purchasing Information 7.4 7.4.3 Verification of Purchased Product 7.4 7.5 Product and Service Provisions 7.5

7.5.1 Control of Production and Service Provision

7.5

7.5.2 Validation of Processes for Production and Service

7.5

7.5.3 Identification and Traceablity 7.6 Welding 7.8 22-09201A Heat Treatment 7.4 22-09203A

Examination and Inspection Program 7.7 22-09205A 7.5.4 Customer Property 7.6 7.5.5 Preservation of Product 7.6 7.6 Control of Monitoring and Measuring

Devices 7.10 22-09204A

7.7 Examination and Inspection 7.9 8 Measurement, Analysis and

Improvement 8.1

8.1 General 8.1 8.2 Monitoring and Measurement 8.2

8.2.1 Customer Satisfaction 8.2 8.2.2 Internal Audit 8.3 18-09208A 8.2.3 Monitoring and Measurement of

Processes 8.1

8.2.4 Monitoring and Measurement of

Product 8.1

8.3 Control and Correction of

Nonconforming Product 8.4 18-09207A 22-09202A

8.4 Analysis of Data 8.4 8.5 Improvement 8.5

8.5.1 Continual Improvement 8.5 8.5.2 Corrective Action 8.5 18-09207A 8.5.3 Preventive Action 8.6 18-09207A


2.0 SCOPE, RESPONSIBILITY and AUTHORITY

The management of Sentry Equipment Corp. has implemented and uses a quality management system(OMS) to help the company manage the processes that are used to provide products to our customers.

The QMS complies with the international standard ANSI/lSO/ASQ Q9001-2008 and portions of the ASMECode (see (2)). There are two purposes for this Manual:

(1) to document Sentry Equipment's quality management system for all employees whose actions affectproduct and process quality; all customers who want to understand the quality management systemand the controls which are used to assure product quality; and all suppliers who provide materialsand services for the manufacture of product. Sentry Equipment complies with all requirements ofANSI/lSO/ASQ Q9001-2008, there are no exclusions.

(2) to provide documentation for a quality program and system for items subject to the ASME Code,Section Vlll, Division I (hereafter referred to as Code), and stamped with the "U" Construction CodeDesignator.

The content of this Manual provides a single source of information regarding policies at Sentry Equipment forassuring and controlling product and service quality, the continual improvement of the quality managementsystem (OMS) and compliance to requirements defined within ISO Standard 9001:2008.

Further, to ensure compliance to the programs needed for compliance to the applicable ASME Code, thePresident of Sentry Equipment Corp. has authorized the Quality Manager to:

1) ldentify quality problems;

2) lnitiate, recommend and provide solutions;

3) Verify implementation of solutions; and

4) Control further processing or delivery of a nonconforming item, until proper disposition of thedeficiency or unsatisfactory condition has occurred.

The Quality Manager reports directly to the President and is sufficiently independent from the considerationsof cost and scheduling. He has the authority to implement all requirements contained in this Manual and theCode.

The Quality Manager is responsible for defining and measuring the overall effectiveness of the QualityProgram. ln the event of an interdepartmental conflict involving the Quality Manager, it shall be theresponsibility of the President to resolve the matter within the requirements of the Code, CustomerSpecifications and this Manual.

Sections in this Manual describe why Sentry Equipment is undertaking certain activities, describe whatobjectives will be measured and will reference appropriate procedures. Procedures exists as a separate setof documents to compliment this Manual by providing additional explanation of principles, structure,procedures, and resources that will be used to maintain the quality management system.

Brian T. BakerPresident and CEOSentry Equipment Corp

Date

Revision 16 page 7 of 39 FOR REFERENCE ONLY. COPY IS NOT CONTROLLED.


3.0 QUALITY POLICY Sentry Equipment Corp. is dedicated to meeting or exceeding customer's requirements by working closely with them to assure that the highest quality product is provided, delivered on time and to their satisfaction. To accomplish these goals Sentry monitors itself with the use of metrics and incorporates improvements to its Quality System by the use of dedicated resources. Sentry Equipment Corp. encourages its employee owner’s to strive for continual improvement by sharing new ideas at any time that will improve the product or processes of Sentry.

Every Employee an Owner, Every Customer a Commitment

This Quality Policy documents Sentry Equipment’s commitment to quality and was developed by the top management team. It reflects the purpose of the organization, and defines commitment to meet customer requirements. The Quality Manager will oversee the maintenance of the QMS, and will work with top management to find ways to improve the effectiveness of the quality management system. The Quality Manager will ensure that the suitability, appropriateness, and effectiveness of the quality policy is reviewed as necessary.

This policy creates a framework from which quality objectives can be determined and shared with the employees. The policy has been explained to all employees. The policy is also posted in conspicuous locations throughout the company. All employees understand the intent of the policy and know their role in helping Sentry Equipment maintain its commitment to this policy.



4.0 Quality Management System Sentry Equipment has established, documented, and implemented a quality management system (QMS) that satisfies the requirements of ANSI/ISO/ASQ Q9001-2008 and ASME Code, Section VIII, Division 1, and stamped with the “U” Construction Code Designator.

The QMS will be maintained through review for effectiveness and will be adapted during improvement activities. The Manual section regarding Management Review Meetings provides the details of reviews and how improvement activities are begun. Procedures for Corrective Action and Preventive Action further outline the ways in which continual improvement actions are undertaken and reported to management.

4.1 General Requirements of the QMS

4.1.1 Sentry Equipment has established, documented, and implemented a quality management system (QMS) based on the international standard ANSI/ISO/ASQ Q9001:2008. This QMS is maintained and its effectiveness improved in accordance with the requirements of this international standard.

4.1.2 QMS processes and their interactions are mapped in Section 5, Figure 2.0 of this Manual.

4.1.3 Work instructions and Procedures that are separate from this Manual explain the applications of the processes.

4.1.4 Management has developed techniques and maintains proper monitoring, measurement and analysis of the QMS processes. Reviews of the measurements are held during regularly scheduled management meetings.

4.1.5 Sentry Equipment has developed a corrective and preventive action processes to determine and implement any actions needed to achieve planned results and to provide for a method of continual improvement of QMS processes.

4.1.6 If a process that affects product conformity is outsourced, Sentry Equipment places appropriate controls over that outsourced process. Requirements are identified within Sentry Equipment’s QMS and provided to the outsourcing company. Work instructions and records are used.

4.1.7 Procedures, work instructions and work records are used to define the criteria and methods needed to ensure that operation and control of processes are effective and will meet the requirements of the products being produced.

4.1.8 Various employees have been assigned responsibility for operating and monitoring the QMS processes. Specific job functions are described in the responsibility sections of procedures, detailed in job descriptions and/or detailed in work instructions.



4.2 Documentation Requirements

4.2.1 The QMS documentation includes:

4.2.1.1 a documented quality policy, 4.2.1.2 documented quality objectives, 4.2.1.3 Quality Policies Manual, 4.2.1.4 documented procedures required by the ANSI/ISO/ASQ Q9001-

2008 standard, ASME Code and as determined by Sentry Equipment’s management,

4.2.1.5 documents needed to ensure effective planning, operation and control of processes (work instructions, specifications, engineering documentation, user’s manuals), and

4.2.1.6 Records required by the ANSI/ISO/ASQ Q9001-2008 standard. 4.2.1.7 Records required by the ASME Code.

4.2.2 The Sentry Equipment Quality Manual has been established to define:

4.2.2.1 the scope of the QMS, 4.2.2.2 the basic policies of the Sentry Equipment Corp. with regards to

quality and the management of process that affect quality, 4.2.2.3 reference to documented QMS procedures, 4.2.2.4 the description of the interaction between the processes of the

Sentry Equipment QMS.

4.2.3 Control of documents

4.2.3.1 Sentry Equipment has established and maintains various types of controlled documents for its QMS. The Control of Documents Procedure defines the controls for:

4.2.3.1.1 Approving documents for adequacy prior to issue; 4.2.3.1.2 Reviewing, updating and re-approving documents; 4.2.3.1.3 Ensuring changes and current revision of documents are

identified; 4.2.3.1.4 Ensuring relevant versions of documents are available at

points of use; 4.2.3.1.5 Ensuring documents remain legible and identifiable; 4.2.3.1.6 Ensuring external origin documents are identified and

have their distribution controlled; 4.2.3.1.7 Preventing the unintended use of obsolete documents 4.2.3.1.8 Identifying and segregating of obsolete documents if they

are retained for any purpose.

4.2.4 Control of records

4.2.4.1 Records are established and maintained to provide evidence of process and product conformity.

4.2.4.2 The Control of Quality Management System Records Procedure



outlines the requirements for identification, storage, protection, retrieval, retention time and disposition. All efforts are made by Sentry Equipment to keep records so they remain legible, readily identifiable and retrievable.



5.0 MANAGEMENT RESPONSIBILITY The senior management team is ultimately responsible for establishing, implementing and maintaining the quality system. The Sentry Equipment president chooses the management team representatives. Specific responsibilities comprise: defining management’s commitment to the QMS, formulating the quality policy, defining organizational authorities and responsibilities, defining communication channels, determining quality objectives and QMS planning, appointing the management representative, periodically reviewing the quality system, and determining the methods used to ensure that customer requirements and customer satisfaction are known.

5.1 Management Commitment

5.1.1 Sentry Equipment’s senior management believes that the assurance of quality is fundamental to the work undertaken by all employees.

5.1.2 It is accepted that consistent high quality can only be achieved by working in a systematic way to predefined, formalized procedures and instructions.

5.1.3 The Sentry Equipment senior management, with assistance of the entire management team, will determine and implement the quality management system (QMS) policies and procedures that will be used to control, assure, and manage quality and quality sub-systems at the company.

5.1.4 Individual departmental managers will be responsible to initiate, document, implement and maintain work instructions for their departments. They will ensure that instructions are fully integrated into Sentry Equipment’s quality management system.

5.1.5 Senior management will communicate the importance of meeting customer, statutory and regulatory requirements to all Sentry Equipment employees by these actions:

5.1.5.1 Establishing and communicating the Quality Policy; 5.1.5.2 Establishing and communicating quality objectives that help drive

business improvements; 5.1.5.3 Reviewing the effectiveness of the QMS at least once per calendar

year using a management review process and communicating the results of this review to employees;

5.1.5.4 Using the process of continual improvement as defined in Sentry Equipment procedures to provide assurance to employees and other stakeholders that the QMS is appropriately implemented and is effective for controlling, assuring and managing quality.

5.1.5.5 Identifying the requirements for resources and acquiring those resources as needed. This will include the appropriate assignment of competent and qualified personnel to complete product realization activities or to complete verification activities, such as internal quality audits.



5.2 Customer Focus

5.2.1 Senior management recognizes that success of the organization depends upon its relationships with its own employees and its external customers. The strategic planning process is designed to determine customer expectations and to help the company develop a balanced approach to responding to expectations. A strategic review takes place annually.

5.2.2 Sentry Equipment’s management has developed methods to ensure that external customers’ requirements are properly determined and communicated during the processes used to make products. Section 7.2 of this Manual provides additional detail.

5.2.3 Sentry Equipment also recognizes the important role that its suppliers play in providing satisfaction to customers. Section 7.4 of this Manual addresses supplier management and the connection to achieving satisfied customers.

5.2.4 Sentry Equipment ensures customer requirements are met and reviewed with the aim to enhance overall customer satisfaction. Section 8.2 provides additional detail regarding the measurement of customer satisfaction and its use to drive quality management system improvements.

5.3 Quality Policy

5.3.1 It is Sentry Equipment’s goal to provide our customers with products that meet or exceed their requirements for product quality, delivery (service) and customer satisfaction. See Section 3.0 of this Manual for the company’s quality policy.

5.3.2 In support of this policy, Sentry Equipment management is committed to continually improving the effectiveness of our quality management system and to ensure an adequate framework for the establishment and review of the quality objectives as defined under Section 5.4

5.3.3 Sentry Equipment will ensure that this policy is communicated and understood by all levels within the organization by providing training sessions and by conducting internal quality audits.

5.3.4 The quality policy is considered appropriate and consistent with Sentry Equipment’s overall business plans. The policy will be reviewed annually at a management review meeting.

5.4 Quality Planning

5.4.1 Sentry Equipment management uses an annual strategic planning process to determine quality performance measures and quality objectives for the company. These measures and objectives are communicated to all employees through the objectives and regular updates of the measures. Updates may be monthly or quarterly, and will be posted for employees.

5.4.2 Quality planning will include these aspects, and additional detail can be found in various work instructions:

a) The processes of the quality management system; b) The resources needed to achieve quality objectives; and c) The continual improvement of the quality management system.



5.4.4 Quality planning also ensures that required changes are conducted in a controlled manner and that the integrity of the quality management system is maintained during the change.

5.4.5 The methods to be used and the personnel responsible for quality planning are further defined in individual job descriptions.

5.5 Responsibility, Authority and Communication

5.5.1 The departmental functions at Sentry Equipment are defined in the

organization chart in this section of the Manual. The Process Flow Diagram for the entire company in Figure 2.0 defines the basic flow of work done to meet customer requirements.

5.5.2 The job responsibilities and authorities of employees at Sentry Equipment are explained in job descriptions. Individual managers are tasked with preparing training plans and for assuring that employees understand how their work affects quality and their specific roles within the quality management system.

5.5.3 The Sentry Equipment Quality Manager will serve as the ISO Management Representative for all internal and external inquiries. In addition to other job responsibilities, the Quality Manager is responsible for:

5.5.3.1 Ensuring that the requirements of this Quality System Manual and

those of ISO 9001:2008 (ANSI/ASQC Q9001:2008) are implemented and maintained.

5.5.3.2 Reporting to top management on the performance of the quality management system and need for improvement through the QMS Management Review (see Section 5.6).

5.5.3.3 Communicating the results of customer satisfaction surveys, management reviews, third-party assessments to Sentry Equipment employees in order to promote the awareness of meeting customer requirements.

5.5.4 Senior management will ensure that communications about the QMS take place within the company using these basic practices:

5.5.4.1 Reviewing the effectiveness of the QMS at an employee meeting on at least an annual basis;

5.5.4.2 Sharing results of performance measures on a monthly, quarterly or annual basis.

5.6 Management Review

5.6.1 The senior management team and management representative review the QMS at least once per year. The purpose of the review is to assess the effectiveness, adequacy and continuing suitability of the quality system as it is integrated within the business.

5.6.2 The management representative will be responsible for scheduling and conducting the reviews.

5.6.3 An agenda for the review meetings will include data gathered regarding the QMS. This review will include assessment by senior management of



opportunities for improvement and a need to make changes to the QMS, quality policy and/or quality objectives. Specific inputs to management review will include: 5.6.3.1 Results of audits; 5.6.3.2 Customer satisfaction feedback; 5.6.3.3 Process and product performance and conformity; 5.6.3.4 Status of preventive and corrective actions; 5.6.3.5 Follow-up actions from previous management reviews; 5.6.3.6 Changes that could affect the QMS; 5.6.3.7 Recommendations for improvement.

5.6.4 Meetings minutes will be taken and any decisions and actions related to these topics will be recorded as management review output:

5.6.4.1 Improvement of the effectiveness of the QMS and its processes; 5.6.4.2 Improvement of product related to customer requirements; 5.6.4.3 Resource needs.

5.6.5 Minutes of the review meetings will be recorded and maintained according to instructions for QMS records.



5.6.6 Organization Chart (Figure 1.0)

Note: Throughout this Manual described actions and functions are assigned to individuals whose titles appear above. These individuals may delegate the actual work performed by other qualified individuals under their direct line of authority, as indicated by the lines of direction on the Organizational Chart provided the work performed by others is the responsibility of the individual stipulated in the QA Manual.



5.6.7 Process Flow Diagram (Figure 2.0)



6.0 RESOURCE MANAGEMENT Sentry Equipment Corp. recognizes the need to assure that products of our manufacture are designed, assembled, tested and serviced in accordance with practices that result in consistent high quality. Sentry uses written procedures and work instructions for employees (at all levels) to follow through out the company. To ensure that employees through out the company are able to complete their work training is provided to them to ensure that they have the competency to carry out their work.

6.1 Provision of Resources

6.1.1 Senior management has determined resources necessary to enhance customer satisfaction by meeting customer requirements, to implement and maintain the Quality Management System (QMS), and to continually improve the effectiveness of the QMS. These resources are referenced throughout this Manual.

6.1.2 Resource needs at all levels will be determined on an on-going basis by senior management and may or may not be part of the corrective action, preventive action, continual improvement, or management review records.

6.1.3 Jobs at Sentry Equipment are defined by job descriptions, and personnel are evaluated against those job descriptions prior to hire or promotion. Where gaps are identified in skills, training is provided.

6.1.4 Competency is evaluated after training and training will be repeated as necessary. Also see the section titled Competence and Training.

6.2 Overall Awareness of the QMS

6.2.1 It is the responsibility of the Quality Manager to communicate with Sentry Equipment’s associates to help them see how the work that they do affects product quality and how their work activities impact the achievement of quality objectives for the company.

6.2.1.1 Communication will take place via regularly updated postings of

results against quality objectives/goals and via meetings and planning sessions that will be initiated by the Quality Manager.

6.3 Competence and Training Responsibility and Records

6.3.1 Sentry Equipment’s functional area managers and the Quality Manager have determined the necessary training and competency evaluation methods needed for personnel performing work affecting product quality. The goal of evaluation is to ensure actions taken in training have been effective, and that the associate is prepared to properly do the work on a regular basis.

6.3.2 Training responsibility for work affecting product quality and the ability to meet customer requirements:

6.3.2.1 The Quality Manager has the responsibility to ensure that employees

exercising procedures, which affect the safe operation of products, are deemed competent to complete these procedures. Procedures which meet this criterion are Weld Examination, Liquid (Dye) Penetrant Examination, Leak & Hydrostatic Testing, electrical



Continuity and Dielectric (hi-pot) Strength.

6.3.2.2 The Production Manager has the responsibility to ensure that Machinists, Welders, and Assemblers are suitably trained in assembly/test techniques for products to which they are assigned.

6.3.3 After training, competency will be determined for each employee, (including

managerial function) using testing, observation and oversight. Records will be maintained as indicated in this Manual.

6.3.3.1 Training conducted by, or at the direction of the Quality Manager, will

be documented and recorded, which identifies the title of the training, the instructor, the date of instruction, and grade on a written examination. Certification of employees is maintained in a training database.

6.3.3.2 Training conducted by, or at the direction of the Production Manager, may be based on observation and oversight. Once the employee has demonstrated skills sufficient to produce product per requirements, he/she is deemed competent to assemble and test that product. A list of employees and their training records are available in the training database.

6.4 Infrastructure and Work Environment

6.4.1 Sentry Equipment provides adequate buildings, workspace, environmental controls, work environment, process equipment and supporting services in order to achieve product conformance requirements. Work instructions and procedures for work processes address the details of infrastructure and work environment needs. Management oversees the creation of these procedures and instructions, and the Quality Manager ensures requirements are met through the use of quality management systems audits and the achievement of quality objectives. Also see the section on Internal Audits for details regarding this process.

6.4.2 Sentry is committed to managing the work environment to provide safe and healthful working conditions for its associates. The safety committee and management work together to achieve both.



7.0 PRODUCT REALIZATION Sentry Equipment management has identified all pertinent processes for product realization and has controlled these processes with procedures and work instructions. Sentry Equipment associates know the importance of following established methods and the value of keeping appropriate records for all activities that support the selling, design, manufacture and shipping of products. Regularly scheduled internal audits verify the proper use of the system and allow for continual improvement activities.

7.1 Overview of Product Planning Controls

7.1.1 Sentry Equipment designs and manufactures products for a variety of industries. Regardless of product type, the same process steps are used to provide a product that meets the customer’s requirements. These process steps are controlled through detailed procedures and work instructions.

7.1.2 Sentry works closely with its customers to design products to meet or exceed requirements. Sales and Engineering have primary responsibility for learning the voice of the customer and communicating needs throughout the company.

7.1.3 Engineering, Quality, and Manufacturing establish the processes and documentation needed to support design and manufacture of the Sentry products. Senior management provides resources needed to support product realization efforts.

7.1.4 Engineering determines the required verification, validation, monitoring, inspection and test activities for products and the criteria for product acceptance. Documentation is controlled via the Documents Control Procedure.

7.1.5 Engineering determines what records are needed to provide evidence that processes have been carried out according to documented instructions and that products meet the requirements. Records are controlled via the Records Control Procedure.

7.2 Customer-related Processes

7.2.1 The VP Power or VP Process works with the customer to determine requirements related to the product. Requirements to be determined before an order can be accepted include:

7.2.1.1 customer-specific product requirements; 7.2.1.2 requirements for delivery and post-delivery (service) activities 7.2.1.3 product requirements not specified by the customer but essential for intended or specified use; 7.2.1.4 statutory and regulatory requirements; and 7.2.1.5 any additional requirement determined relevant by Sentry Equipment.

7.2.2 The VP Power or VP Process will administer all contracts for custom engineered products, including initiating customer correspondence and maintaining contract-related correspondence. The VP Power or VP Process shall transmit all contract modifications to engineering. All contract communications with the customer are documented per written procedures.



7.2.3 In limited cases where the customer does not provide a documented requirement, The VP Power or VP Process will contact the customer to verify requirements prior to acceptance of the contract.

7.2.4 The VP Power or VP Process, or designee from Customer Service, is responsible for the order entry process and those written procedures that affect the order entry process.

7.2.5 The VP Power or VP Process is responsible to resolve all contract discrepancies with the customer and to assure that all affected internal and external parties are informed of contract modifications.

7.2.6 Customer Service will receive and review all new customer purchase orders (contracts). See sub-points below. At the completion of the review by the appropriate individual, Customer Service will enter the order within Sentry’s Materials Requirements Planning (MRP) system and will electronically signify (enter) who completed the order review before being allowed to complete the order entry. Records of contract/order reviews and modifications are maintained in files or within the MRP system.

7.2.6.4 If required, Customer Service will route orders for custom engineered

and made to order products to the appropriate Applications Engineer who shall perform an initial review to determine general acceptability.

7.2.6.5 The Applications Engineer will deliver all orders for custom engineered products with all accompanying drawings and specifications to the Product Engineer for engineering review. The engineering review shall cover the specifications and drawings, as appropriate; to assure that the order can be accepted.

7.2.7 In general, the VP Power or VP Process is tasked with communication

arrangement decisions related to the customer. These persons are the customers’ primary contact for new business or order changes to products.

7.2.7.4 Customer Service may assist customers with open order

communication, such as amendments to the order. 7.2.7.5 Quality management will be involved with customer feedback, which

may include both customer kudos and complaints.

7.3 Design and Development

7.3.1 Sentry Equipment plans and controls the design and development activities for all new, and revised products as well as application of existing products. Activities include planning, design review, design inputs, design verification, design validation, design changes, and design outputs. Detailed requirements for each activity can be found in the Design Procedure.

7.3.2 Design and development planning includes:

7.3.2.1 The VP Power, VP Process or Chief Technology Officer, assigning



an Engineer (Product Engineer, Design Engineer or designee) to the engineered product and defining all appropriate interfaces.

7.3.2.2 Determining each design and development stage; 7.3.2.3 Determining the appropriate review, verification and validation

activities for each design and development stage; 7.3.2.4 Defining the responsibilities and authorities for design and

development activities;

7.3.3 Design and development review: at suitable stages of the new product design process, Sentry Equipment Engineering performs systematic reviews as described in the Design Procedure. These reviews will evaluate the ability of design and development to meet requirements, identify any problems, and propose necessary actions to address the problems.

7.3.3.1 Participants in reviews will be those representatives from Sentry

Equipment, its suppliers or customers whose presence is pertinent. 7.3.3.2 Results of these reviews and resultant necessary actions are

recorded and maintained in the job folder.

7.3.4 Design inputs are reviewed by designated individuals comparing them to the project specifications to assure that the inputs are not incomplete, ambiguous or in conflict with each other and that they are documented.

7.3.4.1 Design Inputs shall be functional and meet performance

requirements 7.3.4.2 Detailed requirements of design inputs can be found in the Sentry’s

Design Procedure.

7.3.5 Design and development outputs will be in a form that allows for verification against the design and development input. The Engineer (Product Engineer, Design Engineer or designee) will coordinate the completion of design output activity:

7.3.5.1 Meet the design and development input requirements 7.3.5.2 Provide appropriate information for purchasing and production

7.3.6 Design and development verification at Sentry Equipment is based on the

complexity of the work and the product being developed. Verification is done to ensure that the design and development outputs meet the design and development input requirements.

7.3.6.1 Verification of documents are reviewed and approved based on the

product type as defined in the design procedure.

7.3.7 Sentry Equipment relies on its customers to complete design and development validation activities for engineered products, in order to ensure that the resulting product meets the requirements for the intended use.



7.3.7.1 Partial validation activities may be completed by Sentry Equipment. 7.3.7.2 Sentry Equipment also provides field servicing activities. See the

section (7.12 of this Manual) on Servicing for additional details of controls.

7.3.7.3 Records of validation activities for new products are typically maintained by the customer. When these results are shared, they will be filed with the appropriate job information by Sentry.

7.3.8 Control of design and development changes: The VP Power, VP Process or

Chief Technology Officer has responsibility for coordinating all design changes per the Design Procedure.

7.3.9 The Quality Manager or designee may review the Production Department

(“Shop”) copies of drawings, specifications, procedures and bills of material for items requiring inspection and shall make them available for third party inspectors.

7.3.9.1 ASME further requires a relationship between Sentry Equipment

Corp. and an Authorized Inspector (A.I.). 7.3.9.2 RESPONSIBILITY: The Quality Manager shall assure that the

Authorized Inspector is kept sufficiently informed of all work in progress and that all nondestructive examination procedures, personnel qualifications, and procedure qualifications are made available for him to perform his prescribed duties in accordance with the requirements of the Code.

7.3.9.3 The Quality Manager shall assure that the Authorized Inspector is

given the opportunity to witness nondestructive examinations performed on ASME Code material or subassemblies and to provide suitable examination facilities for the evaluation of radiographs.

7.3.9.4 GENERAL: The Authorized Inspector is an inspector regularly

employed by an ASME/National Board accredited authorized inspection agency. The Authorized Inspector shall possess a National Board New Construction Commission with the “A” endorsement on his commission card.

7.3.9.5 QMS MANUAL: A controlled copy of this Manual shall be provided for

the Authorized Inspector's use within Sentry Equipment Corp. The Authorized Inspector shall review and accept all revisions to this Manual prior to implementation or inclusion. The Authorized Inspector shall provide evidence of this acceptance, which is shown on the cover page.

7.3.9.6 LIAISON: The Quality Manager, or designee, shall provide all liaisons



with the Authorized Inspector.

7.3.9.7 ACCESS TO INSPECTOR: The Authorized Inspector shall have free

access to all locations where Code activities are being performed on an item and to review all documentation related to Code work. The Quality Manager shall assign personnel to assist and accompany the Authorized Inspector. Free access shall also be given to the Authorized Inspector's Supervisor during the Supervisor's audits and as requested by the Authorized Inspector.

7.3.9.8 INSPECTIONS: Prior to start of fabrication the Certified Performance

Record (CPR) (Procedure 22-09205A Exhibit 1.) for the item/assembly shall be presented to the Authorized Inspector for designation of his required inspection points.

Provisions shall be made in the CPR for the Authorized Inspector to establish a hold point for his internal inspection prior to closure or through an inspection opening.

The Quality Manager shall notify the Authorized Inspector with

sufficient advance notice (as agreed by the Inspector) of all impending inspection points.

7.3.9.9 QUALIFICATIONS/REQUALIFICATIONS: The Authorized Inspector

shall be notified of pending qualifications tests for welding procedures, welders and welding operators. He shall have the opportunity to witness the welding performed and the mechanical testing of the weld sample. The Authorized Inspector may require re-qualification of any welding procedure specification or any welder/welding operator whenever he has specific reason to question the suitability of the procedure or the qualification of the welder/welding operator. The Authorized Inspector may require re-qualification of NDE procedures or personnel whenever he has specific reason to question the suitability of the procedure or the qualification of the NDE personnel.

7.3.9.10 NONCONFORMITIES: The Authorized Inspector is notified of all

nonconformities which affect Code requirements and their disposition (including scrap) by copies of the Nonconformity Reports. Nonconforming materials' dispositions involving weld repairs to a pressure retaining Code item shall be accepted by the Authorized Inspector prior to the repairs beginning. Copies of all nonconformity documentation are retained by Quality Assurance and are available to the Authorized Inspector.

7.3.9.11 AUDITS: The Quality Manager shall provide assistance to the

Authorized Inspector's Supervisor on his audits.



7.3.10 The Engineer, or designee, shall release for manufacture only items and assemblies which have all required engineering activities completed per the Design Procedure.

7.4 Purchasing and Materials Control

7.4.1 Sentry Equipment purchases raw materials, components and equipment from outside suppliers in order to make products for its customers. Sentry Equipment provides all pertinent information to its suppliers by use of a Suppliers Manual to ensure that purchased product conforms to Sentry Equipment requirements. Various types of controls are placed on suppliers, depending on the effect the supplied item has on the Sentry Equipment final product.

7.4.2 Several different functional areas within Sentry have responsibility toward materials control. Additional details outlining specific activities can be found in applicable work instructions.

7.4.2.1 The VP Power or VP Process is responsible for the complete and

accurate preparation of all internal material definition documents and for compliance of such material definition documents with all technical aspects required by the customer contract.

7.4.2.2 Design Engineers or Product Engineers are responsible for defining all pressure boundary materials, attachment materials, and structural supports under the jurisdiction of the Contract.

7.4.2.3 The Materials Manager is responsible for preparation, distribution and control of purchase orders.

7.4.2.4 The Production Manager is responsible to assure that production personnel comply with this section and that material is properly stored and handled.

7.4.2.5 The Quality Manager is responsible to assure all items and materials are properly received and inspected.

7.4.2.6 The Quality Manager is responsible to approve all suppliers of calibration and nondestructive examination services. Records of these approvals are maintained by Quality.

7.4.3 Suppliers of materials and services are selected and evaluated as an on-

going process. Evaluation will be conducted by the Quality Department at the direction of the Quality Manager. Results of the evaluations will be documented.

7.4.3.1 When discrepant materials or services are provided by a supplier,

see the Nonconforming Materials Process procedure for details about the escalation of actions needed by the supplier to resolve and correct the situation.

7.4.3.2 Sentry’s Quality Manager shall have sole responsibility as to whether the supplier will be allowed to receive future purchase orders. Future purchase orders to suppliers that have unresolved Corrective Action



Requests (CAR’s) (Reference Procedure 22-09202A, Exhibit 5) will be conditional. In order to be re-evaluated and approved to resume unconditionally as a supplier, the supplier will resolve any open CAR’s to the satisfaction of the Quality Manager according to the requirements of the Corrective and Preventive Action procedures.

7.4.4 Purchasing information describes the product, component, sub-assembly or

service to be purchased. Purchasing information is maintained in a Materials Requirements Planning system (MRP). For welding materials and other special commodities, additional controls may be needed through the use of the Manual Requisition System (MRS).

7.4.4.1 The Project Manager, Product Engineer, Design Engineer or

Manufacturing Engineer is responsible to identify heat treatment and other special manufacturing process requirements on drawings, to review and approve all special process procedures, and to provide technical support to the Production Department.

7.4.4.2 The Quality Manager will maintain appropriate records for special processes such as heat treatment.

7.4.5 Purchased product is verified in order to ensure that purchase meets

specified purchase requirements. 7.4.6 As needed, the Quality Manager, or designee, will prepare Specific Product

Receiving Instructions which detail the dimensional requirements, sampling methods, etc. for receipt inspection of items such as pipe, tube, plate, bar, instruments, analyzers and any other components.

7.4.7 When appropriate, the Quality Assurance (QA) Inspector will examine the material and review the Material Test Report and other documentation using the parameters of the Purchase Order, the Specific Product Receiving Instructions, and the Material Test Report Requirements sheet as the acceptance criteria. Any deficiency of the material or the documentation shall be treated as a discrepant material or nonconformity.

7.4.8 If the material and supplied documentation are in full compliance with the acceptance criteria, the material is accepted by the QA Inspector.

7.5 Production and Service Provision General Requirements

7.5.1 Sentry Equipment plans and carries out production under controlled conditions. These controlled conditions can include, as applicable:

7.5.1.1 A contract that provides the appropriate information and references

for manufacturing the products; 7.5.1.2 Available procedures and work instructions to define and control

important product realization process steps; 7.5.1.3 Use of suitable equipment and trained and qualified personnel; 7.5.1.4 Use of appropriate monitoring and measurement devices; 7.5.1.5 Implementation and use of monitoring and measuring; 7.5.1.6 Implementation of material control, materials and finished product

release, delivery and post-delivery activities, including servicing.



7.5.1.7 As Sentry produces products conforming to ASME Code, this Manual

contains appropriate references and explanation about processes required to be documented per this Code.

7.5.2 Production processes at Sentry Equipment have been planned to include a

monitoring and measurement step. If the final product output cannot be verified by subsequent monitoring and measurement, the affected processes will be validated per Sentry Equipment requirements. Validation will provide assurance that the processes are capable of achieving desired results.

7.5.2.1 If a product in use by a customer has deficiencies that could have

been prevented through process validation, corrective action will include the addition of validation activities for the future.

7.5.2.2 Work instructions provide the details of appropriate validation activities. These validation activities typically include the following:

7.5.2.2.1 Defined criteria for review and approval of the process; 7.5.2.2.2 Approval of equipment and qualification of personnel; 7.5.2.2.3 Use of specific methods and procedures; 7.5.2.2.4 Requirements for records; 7.5.2.2.5 Revalidation.

7.6 Identification and Traceability, including Customer Property

7.6.1 All material under the Contract, including weld material, shall be controlled during receipt, receiving inspection, storage, issuance, and incorporation into the finished product.

7.6.2 MATERIAL STORAGE: Materials intended for a specific Contract shall be committed to that Contract. Welding materials shall be kept in an ASME Code storage area or may be moved to a controlled area (including holding ovens) under the direction of the Production Manager.

7.6.3 MATERIAL IDENTIFICATION: Material and parts will be marked with the Sentry part number by any method which will not result in damage to the items. As applicable, a serial number will be added to any items or subassemblies if indicated on the Inspection Traveler. A QA Inspector will verify that all items are suitably identified prior to approval of any inspection/examination activity.

7.6.4 If a customer provides its property to Sentry Equipment, all effort will be made to properly protect and safeguard the property. Customer property can include intellectual property.

7.6.4.1 Customer property will be identified and conformance verified prior to

use or incorporation into product. Customer Service will issue a Return Materials Authorization (RMA) to the customer to control receipt of the materials. Product Management is tasked with acceptance of the materials and notification that the materials are ready for inclusion into the customer’s product.

7.6.4.2 If customer property is lost, damaged, or found to be unsuitable for use, Customer Service or Product Management will notify the customer. Records of the nonconformance will be written and maintained per the Nonconforming Product Procedure. If materials



are to be returned to the customer, the customer will be treated as a supplier, and the process to return materials will be used.

7.7 Examination and Inspection

7.7.1 As a manufacturer of products subject to ASME Code, Sentry Equipment will use appropriate examination and inspection processes to assure conformance to requirements and specifications. Details describing how the processes will be completed are provided in sections 7.3.9.1- 7.3.10.

7.7.2 Various records will be prepared by the Project Manager, Design Engineer,

Product Engineer, Manufacturing Engineer, or Designee and the Quality Manager for use in the manufacturing areas. It is the responsibility of the Production Manager to assure that production personnel are appropriately trained and are expected to properly complete any processes and maintain any records. It is the responsibility of the Quality Manager to assure that all inspection personnel are appropriately trained and are expected to properly complete any processes and maintain any records.

7.7.2.1 Records may include the Certified Performance Record (CPR)

(Reference Procedure 22-09205A, Exhibit 1) for Code applications, or the Inspection Traveler (IT), and/or Inspection Checklist (checklist) for non-Code applications.

7.7.2.2 If a third party inspector will be inspecting products, it is up to the Quality Manager to ensure that inspector is completing his work according to the IT, procedures and instructions.

7.7.3 QA Inspectors are assigned at appropriate manufacturing steps to do

inspections and examinations per the documented procedures and work instructions.

7.7.4 In-process Inspection overview:

7.7.4.1 If a product has an IT and CPR, a QA Inspector will complete the inspections per procedures and instructions and record the results on the appropriate record.

7.7.4.2 If a product has a Checklist, the Assembler will perform all inspections for both Make-to-Order (MTO) products and Engineer-to-Order (ETO) products.

7.7.4.3 Quality may perform inspections for both Make-to-Order (MTO) products and Engineer-to-Order (ETO) products, when required by Contract and/or as indicated on the IT/Checklist.

7.7.4.4 The Customer’s Inspector will perform those inspections as designated on the IT. Further operations will not commence until the Customer’s Inspector has signed and dated the IT.

7.7.5 Final Inspection and Test overview: Testing shall be witnessed by a QA

Inspector and the Customer’s Inspector, when required by Contract and/or as indicated on the JobTraveler/CPR/IT. After satisfactory testing, the Customers Inspector and the QA Inspector shall sign-off as witnessing the test on the IT. For nonconforming materials or items, refer to the



Nonconforming Procedure.

7.7.6 After completion of all testing, the QA Inspector shall inspect completed items for conformity to applicable drawings. All rework/repair shall be reviewed for conformity to Contract requirements and to assure adequate documentation.

7.7.6.1 Test Procedures shall be prepared by the Project Manager or a

designee and submitted to the Customer for review/approval, as required.

7.7.6.2 The QA Inspector shall be responsible for supervising, monitoring, and/or inspecting during testing.

7.7.7 As required by contract, a Document Package will be planned and prepared

by the Quality Manager or QA Inspector. This package will be submitted to the customer.

7.8 Welding Control

7.8.1 Controls are utilized to assure that all welding is controlled in accordance with the requirements of the contract and accomplished by qualified personnel using qualified procedures. This Manual provides an overview of the control process and the responsibilities. Welding Procedures and instructions give the details for assuring all parts of the process are properly controlled and maintained.

7.8.2 The Product Engineer or Design Engineer will identify the welding requirements on the drawings and provide technical support to the Production Department.

7.8.3 The Production Manager has the responsibility to assure that all welding conforms to the requirements of the design drawings. The Weld Supervisor (Weld Team Leader or Work Cell Team Leader) makes certain all welders and welding operators are qualified for the specific welding operation performed and provides direct supervision and technical control of all welding operators and welders.

7.8.4 The Quality Manager prepares all Welding Procedure Specifications (WPS), Procedure Qualification Records (PQR), and Welding Performance Qualifications (WPQ), Welder Operator Performance Qualification (WOPQ) and maintains the updates to these documents and records. Procedures and instructions are maintained in a manual accessible to all pertinent personnel involved with the welding processes.

7.8.5 The Quality Manager assures that all qualification tests are performed and tested in accordance with the Contract. The Quality Manager is responsible for approving all testing documents. The Quality Manager will issue a welder qualification list on a quarterly basis.

7.8.6 Documents and records pertaining to welding control are listed here. The Quality Manager and Engineers use Section IX of the ASME Code. ASME forms are used to guide the preparation of records at Sentry.

7.8.6.1 Welding Procedure Specification (WPS) ASME Form QA-482 7.8.6.2 Procedure Qualification Record (PQR), ASME Form QW-483 7.8.6.3 Welder Performance Qualification (WPQ, ASME Form QW-484A 7.8.6.4 Welder Operator Performance Qualification (WOPQ) ASME Form



QW-484B

7.8.6.5 Detailed Welding Procedures

7.9 Nondestructive Examination (NDE)

7.9.1 The Quality Manager will develop, maintain and implement any procedures (see procedure 22-09205A, ASME Examination and Inspection) related to Liquid Penetrant Testing (PT) and any other required NDE. Control and distribution of procedures is defined by the Document Control procedure.

7.9.2 Qualification of personnel conducting NDE will be done in accordance with Appendix 8 of Section VIII, Division 1 in the ASME Code and SNT-TC-1A. Records are maintained by the Quality Manager.

7.9.3 Authorized Inspectors will be given access to procedures and personnel qualification records.

7.10 Calibration of Measurement and Test Equipment

7.10.1 Sentry Equipment has determined which tools, standards, gauges, precision measuring tools, applicable computer software, instruments and other measuring and test equipment need to be part of the calibration program.

7.10.2 The Quality Manager will manage procurement, calibration, record

maintenance, issuance, use and collection of measuring tools, gauges and applicable computer software in accordance with Sentry Procedure QA500.15. Additional details of controls and methods will be found in this procedure. The Quality Manager will make all calibration records available to third party inspectors.

7.10.2.1 All suppliers who perform calibration of standards, gauges and

instruments shall be approved by the quality function. 7.10.2.2 Actual results of calibrations will be maintained by the Quality

Manager.

7.10.3 All master standards used for calibration by Sentry Equipment Corp. or subcontractors shall be traceable to the National Institute of Standards and Technology (formerly NBS), whenever such standards exist. Should no standard exist, the manufacturer's recommended standard is utilized.

7.10.4 The quality function determines the schedule for calibration intervals. Calibrated items are suitably identified.

7.10.5 Procedures for calibrated item use include requirements for safeguarding the item from damage and deterioration. Directions help to ensure that no adjustments would be made that would invalidate the measurement result.

7.10.6 When discrepancies in examination or testing equipment are found at calibration, a Nonconformity Report is generated and the Quality Manager shall determine what corrective action is required. This includes a review of previous calibration results.

7.11 Handling, Storage and Shipping

7.11.1 Engineering and Quality functions will be responsible for developing and



maintaining procedures for handling, cleaning, storage, shipping and preservation, including provisions for marking products made by Sentry Equipment. The goal of these procedures is to safeguard products and their constituent parts from damage, deterioration and/or loss either during internal processing or for delivery to the customer.

7.11.2 All specified procedures including revision level shall be included on the Inspection Traveler (IT). Sign off on the IT will indicate that compliance with procedures has been met.

7.11.3 All Sentry Equipment personnel performing these functions will be trained in the proper use of methods described in these procedures.

7.12 Servicing

7.12.1 Sentry Equipment does provide after-sale activities to its customers, including installation, commissioning, start-up and on-going servicing of custom equipment.

7.12.2 The VP Power or VP Process will coordinate the preparation of procedures and/or instructions for service personnel to use. These procedures and instructions provide a series of controlled conditions under which service can be delivered.

7.12.3 The Director Aftermarket Parts & Service or Product Support Supervisor will assure proper implementation and use of the procedures and instructions by service personnel. The procedure for Servicing provides additional details.

7.12.3.1 Service Technicians will be qualified on the basis of experience,

training, technical education and on-the-job training.

7.12.4 Records of service work will be maintained in the Sentry shop order file for the equipment serviced.



8.0 Measurement, Analysis and Improvement

Sentry Equipment’s management team plans and implements the monitoring, measurement, analysis and improvement processes needed by the company to demonstrate product conformity, show conformity of the QMS and continually improve the effectiveness of the QMS. Evidence of this planning can be seen in descriptions of activities throughout this Manual, and in the procedures and work instructions used to control processes within the QMS. 8.1 Management defines and coordinates the completion of activities such as:

8.1.1 Defining and re-defining goals and objectives for quality improvement in products and processes.

8.1.2 Conducting management reviews per the requirements of ISO 9001:2008. 8.1.3 Monitoring and measurement of products through examination and

inspection, NDE, calibration of measuring equipment, and statistical analysis of results.

8.1.4 Monitoring and measurement of processes that demonstrate the ability of the processes to achieve planned results. This may include statistical analysis of results.

8.1.5 Gathering information relating to customers perceptions as to ascertain customer satisfaction with Sentry products and services.

8.1.6 Planning and conducting internal audits that gauge conformance and effectiveness of the QMS.

8.1.7 Controlling nonconforming products from unintended use. 8.1.8 Maintaining a corrective and preventive action (CAPA) process that allows

for actions to be taken, which are appropriate to the effects of actual or potential nonconformities.

8.1.9 Analysis of data from customer satisfaction, product conformity results, process trends and suppliers.

8.2 The purpose for the activities described in 8.1 is to provide a framework for

continual improvement of the QMS. 8.3 Internal Audits:

8.3.1 Sentry Equipment has planned an internal audit program to determine

whether the QMS conforms to procedures and instructions, requirements of ISO 9001:2008 and to QMS requirements explained in the Manual.

8.3.2 A procedure has been developed by the Quality Manager to control all activities related to internal auditing. See Procedure 18-09208A.

8.3.3 The Quality Manager will be responsible for planning and scheduling internal audits of all processes within the scope of the QMS and will use appropriate methods to assure resolution of discrepancies.

8.3.3.1 An internal audit of the processes within the QMS will be conducted at

least once a year. 8.3.3.2 Auditors will be assigned to audits such that they will not audit their

own work. 8.3.4 Once audit results are analyzed by the lead auditor and the Quality

Manager, management will be responsible for taking actions as prescribed in



corrective or preventive action requests.

8.3.5 The Quality Manager will assure follow-up activities are taken and that at least a verification of actions taken will be done by an auditor and that the verification results will be reported to management.

8.3.6 Audit results and subsequent actions are reviewed during Management Review, per the requirements of these procedures: Internal Audits, Management Review, Corrective Action and Preventive Action.

8.4 Control of Nonconforming Product

8.4.1 Nonconformities may be identified during receiving inspection, in-process inspection, final inspection or any other process activities. All Sentry personnel are responsible for identifying nonconformities. Requirements for Sentry Equipment’s control of nonconforming product are found in the Nonconforming Materials Control Procedure.

8.4.2 Once nonconformity is found, it is to be identified, and as practical, segregated to a specific holding area.

8.4.2.1 Personnel in the Storeroom and Quality departments have primary

responsibility to inspect/review the nonconformances to determine if they require further action.

8.4.2.2 If further action is required, the nonconformance is logged electronically using a computer generated ID and format and receives a Discrepant Materials Report (DMR).

8.4.2.3 Materials are then tagged for identification purposes. 8.4.3 Disposition of logged materials will be under the coordination of the Quality

Manager. A material review board (MRB) method will be used. The MRB team is cross-functional in nature, and this team determines the disposition. Disposition options and methods are described in detail in the procedure.

8.4.3.1 Material nonconformances include those related to job material, job

operations, inventory and purchase receipts and returned material. 8.4.3.2 Other nonconformances related to process activities such as order

entry procedures, engineering methods, etc. are logged as ‘other’ nonconformances,

8.4.3.3 The MRB will determine disposition as either take action to eliminate the nonconformity, authorizing its use, release or acceptance under written concession from the customer, or by scrapping it.

8.4.3.4 As warranted, DMRs will have a Corrective Action Request (CAR) issued per the Corrective Action Procedure.

8.4.4 The Quality Manager will maintain results of actions taken to address the nonconformity. These records will be made available upon request.



8.5 Corrective Action

8.5.1 Sentry Equipment has a process called Corrective Action that is used to eliminate the root causes of nonconformities in order to prevent recurrence. Sentry Equipment personnel use a variety of problem-solving techniques, all of them based on the general method of plan-do-study-act.

8.5.2 The Corrective Action Procedure provides more detail regarding the corrective action process at Sentry Equipment. The Quality Manager has responsibility to coordinate the various parts of the corrective action process. The procedure describes methods for: 8.5.2.1 Reviewing all types of nonconformities (supplied materials, customer

complaints, internal product rejections, product improvement requests, etc.)

8.5.2.2 Determining the root causes of the nonconformities, 8.5.2.3 Evaluating the need for action to prevent recurrence, 8.5.2.4 Determining and implementing the action(s) needed, 8.5.2.5 Creating appropriate records of the actions, 8.5.2.6 Reviewing the actions taken to determine effectiveness.

8.5.3 Not all nonconformities will be addressed using all steps of the corrective action processes at Sentry Equipment. This is to ensure that the use of the corrective action process is appropriate to the effects of the nonconformities that do occur.

8.6 Preventive Action 8.6.1 Sentry Equipment has a process called Preventive Action that is used to

eliminate the causes of potential nonconformities in order to prevent their occurrence.

8.6.2 The Quality Manager and President use the preventive action process to assess the need for action based on an analysis of potential nonconformities. The analysis is presented during management review meetings. The preventive actions planned and taken will be appropriate to address the effects of the potential problems.

8.6.3 The preventive action process is further defined in the Preventive Action Procedure. It defines requirements for: 8.6.3.1 Determining the potential nonconformities and their causes using

appropriate techniques, 8.6.3.2 Using corrective action analysis and failure mode analysis techniques

(and other analysis techniques) to evaluate the need for actions to prevent occurrence of nonconformities,

8.6.3.3 Determining and implementing actions, 8.6.3.4 Creating appropriate records of the actions, 8.6.3.5 Reviewing the actions taken to determine effectiveness.



9.0 Appendix

Exhibit 1 Notification Letter – Quality Manual Control



Procedure Reference Table

Exhibit 2.

QMS KHNP Description 5.0 5.1 Organization 5.6.6 5.1.1 Organization Structure 5.0 5.1.2 Responsibilities and authorities 4.1.8 5.1.3 Verifying activities affecting quality 2.0 5.1.4 Responsibility for Quality Management System 4.1.8 5.1.5 Performing quality functions 7.4/4.1.6 5.1.6 Multiple organizations in execution of contract 1.0 5.2 Quality Assurance Program 1.0 5.2.1 Implement QA program 1.0 5.2.2 In accordance with written documentation 4.2 5.2.3 QA program shall be identified 5.1/5.2 5.2.4 Responsibility shall be clearly identified 4.1.6 5.2.5 QA program shall include technical aspects 5.4 5.2.6 QA program planning and accomplishments of

activities 6.3.1 5.2.7 Training necessary personal 5.6 5.2.8 QA program periodically reviewed 4.2.4.2 5.2.9 Document retention and storage 7.3 5.3 Design Control 7.3.1 5.3.1 Design procedure 18-09007A 5.3.1.

1 Technical instruction

4.2 5.3.1.2

Drawing, design, specs. in accordance with procedures

7.3 5.3.1.3

Design procedure requirements for analysis

7.3.4 5.3.2 Design input control 7.3 5.3.2.

1 Applicable design inputs, codes and standards

7.3 5.3.2.2

Changes from approved design inputs

7.3.3 5.3.3 Design process control 7.3.3 5.3.3.

1 Design activity procedures

7.3.4 5.3.3.2

Quality standards within design documents

7.3 5.3.3.3

Final design review

7.3.6.1 5.3.3. Design activity review



4

7.3.6 5.3.4 Design verification 7.3.6.1 5.3.4.

1 Supplier verification plan

7.3.6 5.3.4.2

Design verification performed by competent individuals…

7.3 5.3.5 Design Interface Control 7.3.2 5.3.5.

1 Design interface identified, documented, and controlled

7.3.8 5.3.6 Design Change Control 7.3.8 5.3.6.

1 Design change procedure

7.3.8 5.3.6.2

Design change approval

4.2.4 5.3.7 Control of records 7.4 5.4 Procurement Document Control 7.4.2 5.4.1 Controlled measure for applicable regulatory

requirements 1.0 5.4.2 QA Manual consistent with provisions of contract Suppliers Manual 5.4.3 Procurement document requirements 7.4.2 5.4.4 Procurement QA review 7.4.3.2 5.4.5 Supplier quality 7.4.4 5.5 Instructions, procedure, and drawings 7.4.4.1 5.5.1 Activities affecting quality shall be documented 7.4.5 5.5.2 Documents prescribe QA activities acceptance

criteria 7.4.6 5.5.3 Instructions, procedure and documents shall be

identified 4.2.3 5.6 Document Control 4.2.3 5.6.1 Control measures shall be established and

documented 4.2.3 5.6.2 Document control measures Suppliers manual

5.7 Control of Purchased Material

Suppliers manual 5.7.1 Control measure in accordance with contract requirements

Suppliers manual 5.7.2 Procurement plan Suppliers manual 5.7.3 Measures for control of purchased items 7.6 5.8 Identification and control of materials, parts and ….. 7.6 5.8.1 Measure for control and identification…… 7.6 5.8.2 QA Manual control of records for design,

manufacturing.. 7.6.2 5.8.3 Identification of storage items, materials parts etc. N/A 5.8.4 Deleted 7.7.1 5.9 Process Control 4.2.3 5.9.1 Process control shall be defined by procedures



7.8 5.9.2 Welding, and etc. accomplished by qualified

individuals 7.8 5.9.3 Employee qualification records 7.7 5.10 Inspection 7.7.1 5.10.1 Inspection completed by qualified individuals 7.7.6 5.10.2 Inspection completed by others than who completed

work 4.2.4 5.10.3 Control of records 7.3.9 5.10.4 Inspection completed by inspection plan 7.3.9 5.10.5 Inspection plan shall include item, steps, documents,

etc. 7.3.9 5.10.6 Suppliers evaluation of inspector 7.7.1 5.11 Test Control 7.7.1 5.11.1 Test conducted by documented procedures 7.7.1 5.11.2 Test procedures or plan to include acceptance

criteria 7.7.1 5.11.3 Tests to include calibration status, etc., 7.7.1 5.11.4 Test results documented and evaluated 6.3.3 5.11.5 Personal qualification procedures maintained 7.10 5.12 Control of Measuring and Test Equipment 7.10.1 5.12.1 Calibration plan, procedures etc., meet relevant req. 7.10.2 5.12.2 Calibration interval defined 7.10.6 5.12.3 Found out of calibration evaluation 7.10.5 5.12.4 Measuring and test equipment storage 7.11 5.13 Handling, Storage and Shipping 7.11.1 5.13.1 Control measure for shipping 7.11.1 5.13.2 Special handling 7.11.2 5.13.3 Instructions for marking and labeling 7.11.3 5.13.4 Operators of special equipment training 7.11.2 5.14 Inspection, Test and Operating Status 7.11.2 5.14.1 Inspection identification 8.4 5.15 Nonconforming Materials, Parts or Equipment 8.4.1/8.4.2 5.15.1 Measure to control … inadvertent installation or use 8.4.3 5.15.2 Nonconformance report 8.4.2 5.15.3 Nonconforming segregation 8.4.3.3 5.15.4 Nonconformance notification to buyer 8.4.3 5.15.5 Nonconformance disposition 8.4.3.3 5.15.6 Copy of nonconformance to buyer 8.4.4 5.15.7 Copy of closed nonconformance with quality

documents 8.5 5.15.8 Buyer may issue corrective action 8.5 5.16 Corrective Action 8.5 5.16.1 A measure shall be established for corrective actions 8.5.2 5.16.2 Comprehensive corrective actions 8.5.2 5.16.3 Root cause analysis



8.5.2 5.16.4 Documented corrective action 8.5.2 5.16.5 Stop work action 4.2 5.17 Quality Assurance Records 4.2 5.17.1 Control of records 4.2 5.17.2 Responsibility for control of records 4.2 5.17.3 Types of records requiring control 4.2 5.17.4 Procedure for record control 4.2 5.17.5 Electronic record control 8.3 5.18 QA Audit 8.3 5.18.1 Planned and scheduled audits 8.3 5.18.2 Audit procedure 8.3 5.18.3 Documented audit results 8.3 5.18.4 Audit follow up


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