Quality Manual
Quality Manual
Quality Manual
MANUAL
ISO 9001 QUALITY MANAGEMENT SYSTEM
TABLE OF CONTENTS
SECTION TITLE PAGE
Table of Contents 1
A Mission Statement 2
B Company Profile 2
C Organizational Chart 3
1 Scope 4
1.1 General 4
1.2 Application 4
2 References 4
3 Terms and Definitions 4
4 Context of the Organization 4
4.1 Understanding of the Organization and its context 4
4.2 Determining the Scope of the Organization 5
4.3 Quality Management System and its processes 5
5 Leadership 6
5.1 Leadership and Commitment 6
5.2 Quality Policy 7
5.3 Organizational Roles, Responsibilities and Authority 7
6 Planning 8
6.1 Actions to address risks and opportunities 8
6.2 Quality Objectives and planning to achieve them 8
6.3 Planning of Changes 8
7 Support 9
7.1 Resources 9
7.2 Competence 11
7.3 Awareness 11
7.4 Communication 11
7.5 Documented Information 11
8 Operation 12
8.1 Operation Planning and Control 12
8.2 Requirements for products and services 12
8.3 Design and Development of Products 13
8.4 Control of externally provided processes, products and services 13
8.5 Production and Service provision 15
9 Performance Evaluation 16
9.1 Monitoring, Measurement, Analysis and Evaluation 16
9.2 Internal Audit 17
9.3 Management Review 17
10 Improvement 17
10.1 General 17
10.2 Nonconformity and Corrective Action 17
10.3 Continual Improvement 19
Appendix 20
A. MISSION STATEMENT
Pyco LLC is a specialty manufacturer of temperature sensors such as thermocouples and RTDs
for various industries. Pyco has been a leading manufacturer for over 50 years. Our mission is
to become a value added supplier to our customers while building trust one client at a time.
We are focused on building relations and providing solutions to y
our temperature sensor needs. Our pledge is to exceed customer expectations via superior
customer service and by providing quality temperature sensors. Pyco employees will,
individually and collectively, strive to provide a working environment that is professional and
well organized. We also want to ensure a work environment that challenges each person to do
his or her best work and offer an opportunity for personal growth and development.
B. COMPANY PROFILE
The Pyco Inc. brand has been a leading manufacturer of temperature sensors for over 58 years.
On September of 2015 a group of temperature sensor professionals bought the company assets
with a vision to make Pyco a leader in the global market. Today the brand name of Pyco
continues to service the market under Pyco LLC.
Pyco operates from its original location in Penndel, PA and its new Head Quarters in Fairfield,
NJ. The team continues to be focused on building relations and providing solutions to your
temperature sensor needs. Our experienced colleagues have been designing and manufacturing
sensors for all critical applications within the following Industries; Power, Oil & Gas, Chemical,
Plastics and Transportation sectors.
Pyco continues to be an all American company that has established a solid working
relationships with some of the best engineering firms and manufacturers of industrial
equipment. The same expertise we provide to them is available to solve your temperature
measurement requirements.
Our commitment to excellence does not just apply to our customers but to our supply chain and
our employees.
C. ORGANIZATIONAL CHART
1. SCOPE
1.1 General
This manual also governs the creation of quality related documents. This manual will be
revised, as necessary, to reflect the quality management system currently in use. It is
issued on a controlled copy basis to the Quality Manager. All other copies are considered
uncontrolled and need not be updated. All employees have access to an uncontrolled
electronic copy of the manual. It may be issued to customers and suppliers on a controlled
copy basis upon customer request. A controlled copy of the procedural binders will also
be provided to the Quality Manager. The employees will also be given access to the
procedure through the server based on the department which they work under.
1.2 Application
All requirements of this International Standard are generic and are intended to be
applicable to Pyco LLC. If any of these International Standard cannot be applied due to the
nature of the business of Pyco LLC and/or its products, then those products will be
considered for exclusion.
2. REFERENCES
The following referenced documents are indispensable for the application of this document:
ISO 9001:2015 Quality Management System - Requirements.
Pyco LLC recognizes its responsibility as a manufacturer of quality products and services.
Pyco LLC has developed and documented a quality management system. The quality
management system complies with the international standard ISO 9001:2015. This
manual describes the quality management system and provides comprehensive evidence
to all customers, suppliers and employees of the specific controls that are implemented to
ensure that our products and services consistently meet and exceed customer and
applicable statutory and regulatory requirements. Pyco LLC also aims to enhance
customer service through comprehensive application of this system.
With the establishment of this Quality Management System, Pyco LLC formalizes existing
processes and procedures and organizes the system to conform to the requirements set forth
in ISO 9001:2015. The company has reviewed the ISO 9001:2015 requirements and has
integrated those requirements in the sequence necessary to ensure comprehensive
interaction of the established processes through all applications within the company. The
company has directed that the appropriate financial, human and operational resources are
utilized to ensure the effective implementation and on-going execution of the elements of the
"system" and its processes and procedures. Monitoring, measuring, analyzing actions are in
place to ensure expected outcomes are achieved, and if not, the appropriate authority and
processes are available to ensure immediate correction action and continual improvement.
We also ensure control over all outsourced products or services.
Pyco does not provide aftermarket services to customers due to the lower feasibility to
rework products that are constantly used at high temperatures and pressures (see 8.5).
The customer holds complete control over the design of the product and suggestions to
drawings are provided to customers when the feasibility to manufacture the product is
affected, which makes Pyco inapplicable to design section (See 8.3)
All company employees are involved in the Quality Management System in one form or
another. The Quality Manager is responsible for maintenance of the QMS documents,
which includes this manual, related documents and procedures.
Pyco LLC has established and maintains a Quality Manual. The Quality Manual includes a
Table of Contents and eight binders that include procedures, documents and forms
necessary to effectively manage the Quality Management System. For Pyco LLC, the
Quality Management System encompasses all of the interrelated functions of the
company. Interaction with the Administration, Sales, Marketing, IT, Operations
Engineering, and Accounting functions of the company have an impact on the quality of
the products and services the company provides to our customers, therefore, this
management system incorporates all of those functions. The company has a framed
diagram posted outside of the office that depicts the relationship between QMS, the
Mission, Policies, and Objectives of the QMS and how this all works within the functional
departments of the company.
5 Leadership
5.1 Leadership and Commitment
Related Documents:
104 Management Review Procedure
Senior management will ensure that customer requirements are determined and are met
or exceeded with the aim of enhancing customer satisfaction (see 8.2.2 and 9.1.1).
Pyco LLC accepts responsibility to satisfy its customers. We execute this responsibility
through comprehensive training of employees; adherence to establish procedures;
commitment to meeting or exceeding customer requirements; and maintaining a
company culture that fosters continuous improvement. Since Pyco LLC is a small business,
APPROVED BY: JOSE ALBERTO APPROVED DATE: 02/27/2020
Rev.: 4 M001 QUALITY MANAGEMENT SYSTEM PAGE: 7 of 20
Senior management will ensure that the quality policy permeates all functional
departments in the organization. It is included in the employee training and it is also
posted in prominent places throughout the facility to maintain high standards within the
Organization. All managers will participate in QC Reviews and Annual Business Plan
Meetings.
Pyco LLC has developed and periodically reviews job descriptions for each employee.
These job descriptions define the roles, responsibilities and authority of each position
within the company. The Quality Manager has the majority of the responsibilities
associated with execution of the QMS.
Related Documents:
111-121 Job descriptions
Pyco LLC has designated the Quality Manager as the person responsible for the overall
planning and execution of the Quality Management System. This responsibility includes an
annual review of all policies and procedures related to the Quality Management System,
an annual review of all documents, forms and reports used by the company to meet the
requirements of the Quality Management System, and monthly reporting of quality issues
and the status of the accomplishment of quality objectives.
Related Documents:
118 Quality Manager Job description
6 PLANNING
The Quality Manager will compile information at periodic internals to review with
the President. Upon successful review of the information, the Quality Manager will
brief all employees. These reviews of the organization's quality management system
are designed to ensure its continuing suitability, adequacy and effectiveness. These
reviews shall include assessing opportunities for improvement and the need for
changes to the quality management system, including the quality policy and quality
objectives. The input for this review will be gathered throughout the year. Records
from management reviews will be maintained (see 7.5.3).
Input for the Management Review of the Quality Management System will be
compiled from the following sources:
Quarterly QC Reports
o List of all the failed parts and customer returns.
o Follow-up actions from previous reviews
o Customer On Time Delivery
Quarterly Key Performance Indicators (KPI) reports.
At a minimum the Quality Manager will review the Inputs, and the managers of each
department will be present for the briefing of the review. The output from the
management review will include a summary of all of the inputs gathered by the
Quality Manager and a summary of the decisions made and the actions to be taken
to improve the Quality Management System, and any additional resources that
might be required for these improvements.
Related Documents:
104 Management Review Procedure
7 SUPPORT
7.1 Resources
Pyco LLC will determine and provide the resources needed to both implement and
maintain the quality management system and continually improve its effectiveness, and
to enhance customer satisfaction by meeting customer requirements.
7.1.1 General
Pyco LLC personnel will possess the requisite education, training, skills and experience
necessary to ensure that customer product conforms to customer requirements.
7.1.2 People
Pyco LLC specifies the qualifications and competency requirements of each position
in the company and this information is found in their respective job description. To
ensure currency and on-going competency the company has training in product,
sales and procedures throughout the year.
7.1.3 Infrastructure
Pyco LLC will determine, provide and maintain the infrastructure needed to achieve
conformity to product and customer requirements. This infrastructure includes the
Pyco LLC will determine and manage the work environment needed to achieve
conformity to product and customer requirements.
7.2 Competence
Employee training is documented via the company Employee Skill Log. Annually,
written performance reviews are conducted for each employee and the basis for the
discussion is their performance against the job description and any specific goals or
objectives that might have been mutually set by the employee and their manager.
7.3 Awareness
The President of Pyco LLC has established a quarterly review of all quality related
issues and objectives, and the Quality Manager is responsible for gathering and
communicating this information to the company.
7.4 Communication
The President of Pyco LLC has established a quarterly review of all quality related
issues and objectives, and the Quality Manager is responsible for gathering and
communicating this information to the company. These results are then tabulated
and presented and trends identified and corrective actions implemented throughout
the organization. The communications tools available for dissemination of this
information are: e-mail; the QC database; Monthly Reports and Quarterly Reports.
The results are then tabulated and presented and trends identified and corrective
actions implemented throughout the organization. The communications tools
available for dissemination of this information are: e-mail; the QC database; Monthly
Reports and Quarterly Reports.
Related Documents:
104 Management Review Procedure
Related Documents:
102A Control of Documents procedure
102B New or Revision Change Form
102C Revision Log
Pyco LLC has established records that provide evidence of conformity to ISO and
company requirements, and written proof of an effective operation of the quality
management system. A documented procedure has been established that defines
the controls needed for the identification, storage, protection, retrieval, retention
and disposition of records.
Related Documents:
103A Control of Records Procedure
103B Record Control Log
8. OPERATION
8.1 Operational planning and control
Product Realization is the term used to describe the work that the company goes through
to develop, manufacture, and deliver the finished goods or services. Since Pyco LLC is a
specialty manufacturer, we are involved in product design, manufacturing, inspection and
shipment to the customer. Our primary suppliers and customers are all ISO certified
companies, therefore, our planning of product realization involves: quality objectives and
requirements for the product; acceptance inspection upon receipt of a product; and
keeping the records necessary to demonstrate product realization.
Related Documents:
300 Engineering Procedures
400 Operations Procedures
500 Manufacturing Procedures
600 Quality Procedures
Related Documents:
206 Customer Satisfaction Survey
Related Documents:
304 Engineering Drawing Procedures
Related Documents:
201 Procedures for entering the SO
Pyco Engineering is responsible for evaluating the feasibility of the design orders,
including the identification of parts needed and scheduling the order.
8.3.4 Design and development controls
Pyco does not make any changes to the design specified by the customer. The
customer has complete design control over the products being purchased by them.
8.3.5 Design and development outputs
Pyco does not have control over the design as the customer controlled and the design
analysis, calculations and documents preceding that are controlled by the customer.
8.3.6 Design and development changes
Design changes are only initiated by engineering when the customer provided design
was not feasible. Changes are evaluated before presenting the suggestion to the
customer. The customer then evaluates and makes changes to the drawing if
necessary which would then be used for production.
8.4.1 General
Pyco LLC will ensure that purchased products and services meet purchasing requirements.
The Operations Manager has developed and maintains the Vendor Qualification
Worksheet which establishes criteria for how to evaluate and choose suppliers. This
criteria must be based on the suppliers’ ability to provide products and services that meet
order specifications, especially product and service quality requirements. Records are kept
for primary suppliers on their ability to meet our and our customers' requirements.
Related Documents:
404A Purchasing Procedures
Records are maintained for all processes, equipment, and personnel. Pyco has established
and maintains procedures to identify raw materials that are received and used throughout
the production process. Inspection and testing results are recorded and indicate product
conformance or nonconformance. Inspection and testing results are maintained according
to procedures to ensure product has passed the required inspection or tests before they
are released.
Pyco has established and maintains procedures for preventing damage and deterioration
of raw materials and products in all phases of manufacture, storage and delivery.
Team members are provided with training in proper handling methods. Training covers
safe handling methods, proper use of handling equipment, and prevention of damage to
product.
Packing, packaging, and marking of products are controlled throughout the production
process to ensure conformance to customer requirements and prevent damage. The
methods of preservation and segregation for preventing damage and deterioration of raw
materials and products are controlled through procedures and work instructions. Final
product is protected and shipped to maintain the quality of the product.
Pyco does not provide aftermarket services like maintenance. It is mainly due to the
various environmental factors such as the pressure and temperature that the products are
exposed to, which would wear down the quality of the thermocouple.
Related Documents:
101A New Employee Procedures
102A Control of Records procedures
105 Training Procedures
601A Non Conformance and Corrective Action Procedures
407 Shipping Procedures
9 Performance evaluation
9.1.1 General
Pyco LLC will plan and implement the monitoring, measurement, analysis and
improvement processes needed to:
Demonstrate conformity to product requirements;
Ensure conformity of the quality management system; and
Continually improve the effectiveness of the quality management system.
Related Documents:
206 Customer Satisfaction Survey
improvement of the effectiveness of the quality management system can be made. This
shall include data generated as a result of monitoring and measurement and from other
relevant sources. The analysis of data will provide information relating to:
Customer satisfaction (see 8.2.1),
Conformity to product requirements (see 8.2.4),
Characteristics and trends of processes and products, including opportunities for preventive
action (see 8.2.3 and 8.2.4), and
Supplier performance (see 7.4.1).
Related Documents:
206 Customer Satisfaction Survey
603A Certificate of Conformance Procedure
601A Non Conformance and Corrective Action Procedure
602B Non Conformance Corrective Action Report
104 Management Review Procedure
Related Documents:
602A Internal Audit Procedure
to ensure its continuing suitability, adequacy and effectiveness. These reviews shall
include assessing opportunities for improvement and the need for changes to the quality
management system, including the quality policy and quality objectives. The input for this
review will be gathered throughout the year. Records from management reviews will be
maintained (see 7.5.3).
10 IMPROVEMENT
10.1 General
The management has taken necessary steps to make Pyco LLC to evolve itself by focusing
on continual improvement. The quarterly reviews create a stage for the corporate
managers to input suggestions to improve not just the quality of the service provided but
also the method in which they are provided and what way it is provided. Our NCCAR
form includes a preventive and a corrective action so that, when there occurs a situation
where Pyco had to do certain step in order to avoid the same issue from happening
again, Pyco would take the initiative to have them incorporated.
Related Documents:
601A Non Conformance and Corrective Action procedures
Related Document:
601A Corrective Action Procedure
601B Non Conformance Corrective Action Report
601C NCDR Label
Related Documents:
602A Internal Audit Procedure
602B Internal Audit Worksheet
602C Internal Audit Training
APENDIX A
QUALITY POLICY
Pyco LLC accepts responsibility to satisfy its customers. We
execute this responsibility through comprehensive training of
employees; adherence to establish procedures; commitment to
meeting or exceeding customer requirements; and maintaining a
company culture that fosters continuous improvement. Since
Pyco LLC is a small business, senior management will ensure that
the quality policy permeates all functional departments in the
organization. Top management will participate in monthly QC
Reviews and Quarterly Business Plan Meetings.
QUALITY OBJECTIVES
Maintain 0 internal NCRs per Quarter
Above 92% Average Customer On Time Delivery
Above 98% Average On Time delivery with Key accounts
Less than 100$ /Quarter in failure cost
0 Customer complaints
4+ Overall Company Performance score through customer satisfaction survey