170726 Metallurgical Solutions - ISO 9001-2015 Compliant Quality … · 2019-02-06 · 7.3 Awareness ... 02/01/2019 PAGE 2 OF 21 8.5.5 Post-delivery activities ... MSI provides ‘Introduction

REVISION DATE: 07/26/2017

Metallurgical Solutions

ISO 9001:2015

Quality Management System Manual

MSI QUALITY MANUAL REVISION DATE: 07/26/2017 LAST UPDATED: 02/01/2019 PAGE 1 OF 21

Table of Contents 4 Context of the organization .................................................................................................................................... 3 4.1 Understanding the organization and its context ................................................................................................ 3 4.2 Understanding the needs and expectations of interested parties .................................................................... 3 4.3 Determining the scope of the QMS .................................................................................................................... 4 4.4 QMS and its processes ......................................................................................................................................... 4 5 Leadership ................................................................................................................................................................. 5 5.1 Leadership and commitment ................................................................................................................................ 5 5.1.1 General .................................................................................................................................................................. 5 5.1.2 Customer focus .................................................................................................................................................... 5 5.2 Policy ....................................................................................................................................................................... 5 5.2.1 Establishing the quality policy ........................................................................................................................... 5 5.2.2 Communicating the quality policy ................................................................................................................... 5 5.3 Organizational roles, responsibilities and authorities ...................................................................................... 6 6. Planning .................................................................................................................................................................. 6 6.1 Actions to address risks and opportunities ........................................................................................................ 6 6.1.1 ............................................................................................................................................................................... 6 6.1.2 ............................................................................................................................................................................... 6 6.2 Quality objectives and planning to achieve them ............................................................................................. 6 6.2.1 ............................................................................................................................................................................... 6 6.2.2 .............................................................................................................................................................................. 6 6.3 Planning of changes .............................................................................................................................................. 7 7 Support ...................................................................................................................................................................... 7 7.1 Resources ................................................................................................................................................................. 7 7.1.1 General .................................................................................................................................................................. 7 7.1.2 People ................................................................................................................................................................... 7 7.1.3 Infrastructure ....................................................................................................................................................... 7 7.1.4 Environment for the operation of processes .................................................................................................... 7 7.1.5 Monitoring and measurement resources .......................................................................................................... 7 7.1.5.1 General ............................................................................................................................................................... 7 7.1.5.2 Measurement traceability ............................................................................................................................... 8 7.1.6 Organizational knowledge ................................................................................................................................ 8 7.2 Competence........................................................................................................................................................... 8 7.3 Awareness .............................................................................................................................................................. 8 7.4 Communication .................................................................................................................................................... 9 7.5 Documented information .................................................................................................................................... 9 7.5.1 General ................................................................................................................................................................ 9 7.5.2 Creating and updating....................................................................................................................................... 9 7.5.3 Control of documented information ............................................................................................................... 9 8 Operation ................................................................................................................................................................ 10 8.1 Operational planning and control ...................................................................................................................... 10 8.2 Requirements for products and services ........................................................................................................... 10 8.2.1 Customer communication ................................................................................................................................ 10 8.2.2 Determining the requirements for products and services ........................................................................... 10 8.2.3 Review of the requirements for products and services ................................................................................. 10 8.2.4 Changes to requirements for products and services ..................................................................................... 10 8.4 Control of externally provided processes, products and services ................................................................... 11 8.4.1 General ................................................................................................................................................................ 11 8.4.2 Type and extent of control ............................................................................................................................... 11 8.4.3 Information for external providers .................................................................................................................. 11 8.5 Production and service provision ....................................................................................................................... 11 8.5.1 Control of production and service provision................................................................................................... 11 8.5.2 Identification and traceability ......................................................................................................................... 12 8.5.3 Property belonging to customers or external providers ............................................................................... 12 8.5.4 Preservation ...................................................................................................................................................... 12


8.5.5 Post-delivery activities ..................................................................................................................................... 12 8.5.6 Control of Changes ........................................................................................................................................... 12 8.6 Release of products and services ........................................................................................................................13 8.7 Control of nonconforming outputs ....................................................................................................................13 8.7.1 ...............................................................................................................................................................................13 8.7.2 ..............................................................................................................................................................................13 9 Performance evaluation ......................................................................................................................................... 14 9.1 Monitoring, measurement, analysis and evaluation ........................................................................................ 14 9.1.1 General ................................................................................................................................................................ 14 9.1.2 Customer satisfaction ....................................................................................................................................... 14 9.1.3 Analysis and evaluation .................................................................................................................................... 14 9.2 Internal audits...................................................................................................................................................... 14 9.3 Management review ............................................................................................................................................ 15 9.3.1 General ............................................................................................................................................................... 15 9.3.2 Management review inputs ............................................................................................................................. 15 9.3.3 Management review outputs ........................................................................................................................... 15 10 Improvement ......................................................................................................................................................... 15 10.1 General ................................................................................................................................................................. 15 10.2 Nonconformity and corrective action .............................................................................................................. 16 10.2.1 ............................................................................................................................................................................ 16 10.2.2 ............................................................................................................................................................................ 16 10.3 Continual improvement .................................................................................................................................... 16 Addendum A Customer RFQ – Order Entry Process ............................................................................................. 17 Addendum B Purchasing – Vendor Approval Process ........................................................................................... 18 Addendum C Process Realization ............................................................................................................................ 21


4 Context of the Organization

4.1 Understanding the organization and its context

Company Metallurgical Solutions Incorporated (MSI) is a leading heat treater of high-speed, low alloy, and tool steels in bulk or machined form. We have been working in Rhode Island since 1989 under the guidance of two families. It is the last commercial molten-salt heat treater in New England. We also have performed Ferritic Nitro-carburizing (FNC) surface finishing since 2009.

Industry The heat treating industry has been with us as long as metal working has. MSI came about in response to a decline in the

practice of salt-bath heat treatment of tool steel. Salt-bath heat treatment is significantly more forgiving (consistent

temperature and rapid heat transfer yield a finer grain size) a process and the preferred method for consistent quality results.

Customers MSI has a variety of customers, both large and small, that use our services for cutting and tool manufacturers. The business is broken up with approximately 38% military/defense, 20% OEM Manufacturers, 28% Tool & Die, 10% Food Processing, and 2% Mining & Processing, and 2% Paper Products.

Competition There are no competitors of MSI for salt-bath heat treatment within New England. Outside of that area there are some

competitors but proximity to customers prevents them from actively working in the New England area.

Context MSI has identified its issues (internal - strengths & weaknesses and external - opportunities & threats) that may affect its business. They are listed in the ‘Risk Management Plan’. Top management reviews any potential or actual changes in the issues during the ‘Management Review’.

4.2 Understanding the needs and expectations of interested parties MSI has identified the parties interested in the business and determined their requirements which are relevant to the MSI

Quality Management System (QMS).

Top management reviews any potential or actual changes in interested parties and/or their requirements during the

‘Management Review’.

INTERESTED PARTY REQUIREMENTS

Customers

• Consistent quality based on their requirements

• 100% on-time Deliveries

• Costs per the Quote/Purchase Order

• Good lines of communication on status of the job

Owners

• Company continues to grow in value and size

• Growth in market share and markets

• Everyone promote a good work environment

• Employees pursue competency in their jobs

Employees

• Knowledge of what is expected of them

• Clear quality requirements on a job-to-job basis

• Steady employment

• Safe and comfortable work environment

Vendors

• Clearly stated requirements

• Sufficient lead times

• Competitive pricing vs other similar vendors or industry standard

• Clearly stated feedback in the event of a nonconformance

Community • Maintain a clean quiet facility appropriate to the neighborhood

Regulators (NBC & DEM) • Participate in annual reviews

• Comply with Solid Waste Containment regulations


4.3 Determining the scope of the QMS The scope of the QMS of Metallurgical Solutions, Inc., located at 85 Aldrich St., Providence, Rhode Island, 02905, is associated

with commercial heat treating and surface conditioning ferrous and non-ferrous metals.

The QMS ‘Quality Manual’ addresses all the required clauses of the ISO 9001:2015 International QMS Standard except 8.3 –

‘Design and Development of Products and Services’ (because MSI only provides services for products that Customers have

designed & developed) and 8.5.5 ‘Post-Delivery Activities’ (because MSI provides no post-delivery warrantees, training, etc.).

Documented procedures and records are identified on the ‘Master Document Matrix’.

The ‘Metallurgical Solutions Organization & Quality Management System’ flow chart provides the description of the

interaction between QMS processes.

4.4 QMS and its processes MSI has established, documented, implemented, and maintains a QMS and strives to continually improve its effectiveness in

accordance with the requirements of ISO 9001:2015 International QMS Standard. The flow chart below describes the inputs

and outputs and interactions between the processes and the QMS.

The criteria and methods needed to ensure the effective operation and control of these processes are identified on the

‘Monitoring and Measurement Matrix’.

Resources needed for these processes are determined during the ‘Management Review’ and MSI top management is

responsible for ensuring their availability.

Assignment of responsibilities and authorities for these processes are identified through functional process flow charts

(appendices) and the ‘Responsibilities and Authorities Matrix’.

The evaluation of these processes and the need for the implementation of any changes needed to ensure these processes

achieve their intended results and improvement of processes and the QMS are determined during the ‘Management Review’.

MSI maintains information to support the operation of its processes and retains documented information to have confidence

that the processes are being carried out as planned.

These documents are identified in the ‘Master Document List’.

Metallurgical Solutions Organization & Quality Management System


4.4.2 MSI maintains information to support the operation of its processes and retain documented information to have confidence

that the processes are being carried out as planned.

5 Leadership

5.1 Leadership and commitment

5.1.1 General Top management demonstrates leadership and commitment by accepting accountability for the effectiveness of the MSI QMS.

They have established the ‘Quality Policy’ and ‘Quality Objectives’ for the QMS that are compatible with the context and

strategic direction of MSI.

Top management has integrated QMS requirements into the business processes and promotes the use of the process approach

and risk-based thinking.

One function of the ‘Management Review’ is to ensure that the resources needed for the QMS are available.

The ‘Quality Policy’ and ‘Quality Objectives’ are compatible with the context and strategic direction of MSI and its QMS

requirements are integrated into their business processes.

MSI provides ‘Introduction to ISO 9001:2015’ training that promotes the use of the process approach and risk-based thinking.

It also communicates the importance of effective quality management, conformance to the QMS requirements, and continual

improvement.

Top management ensures that the QMS achieves its intended results by engaging, directing and supporting persons to

contribute to the effectiveness of the QMS. They call for support by other relevant management roles to demonstrate their

leadership as it applies to their area of responsibility in the ‘Roles, Responsibilities, and Authorities Matrix’.

5.1.2 Customer focus Top management demonstrates leadership and commitment with respect to Customer Focus by ensuring that customer and

applicable statutory and regulatory requirements are determined, understood and consistently met.

During ‘Customer Requirement Reviews’, they determine and address the risks that can affect conformity of services, the

ability to enhance customer satisfaction, and the viability of taking on the service (see ‘MSI - Customer RFQ - Order Entry

Process’ flow chart’).

The “Introduction to ISO 9001:2015’ training encourages all employees to maintain a focus on enhancing customer satisfaction.

Customer Focus is the goal of MSI because of the nature of the business as a provider of a critical service. Attention to detail

of customer requirements, coupled with the aim of enhanced customer satisfaction, is critical to MSI’s success.

5.2 Policy

5.2.1 Establishing the quality policy “The policy of Metallurgical Solutions Incorporated, is to provide a service consistent with customer requirements. MSI

recognizes that in order to meet customer requirements, implementation and maintenance of a Quality Assurance System is

crucial. It is the policy of MSI to demonstrate total dedication to the attainment of 100% quality in the services provided to its

Customers and continual improvement of its Quality Management System.”

5.2.2 Communicating the quality policy MSI communicates the ‘Quality Policy’ to employees during on-boarding, during an annual “all hands” meeting, and on

posters in the plant. It also makes it available to relevant parties, as appropriate per the ‘Master Communication Plan’.

In addition, the ‘Quality Policy’ is periodically reviewed at the ‘Management Review’ to determine its continuing suitability.


5.3 Organizational roles, responsibilities and authorities Top management, consisting of the President, Vice President, General Manager, Facilities Engineer, and Office Manager has

defined and communicated responsibilities and authorities within MSI.

Key positions within MSI, that are responsible for ensuring the QMS is consistently applied to all service realization activities

are included, along with their responsibilities and authorities, in the ‘Roles, Responsibilities and Authorities Matrix’, ‘Quality

Policy’, ‘Job Descriptions’, and other Work Instructions.

These responsibilities include ensuring the MSI QMS conforms to requirements of the ISO 9001:2015 International QMS

Standard, ensuring processes are delivering their intended outputs, reporting on the performance of the QMS and on

opportunities for improvement to top management, ensuring the promotion of customer focus throughout MSI, and

maintaining the integrity of the QMS when planning and implementing changes to it.

6. Planning

6.1 Actions to address risks and opportunities

6.1.1 When top management plans for the QMS, they consider the issues referred to in 4.1 and the requirements referred to in 4.2 as

well as determine the risks and opportunities that need to be addressed by using any one of a variety of Risk Management

tools, including but not limited to: SWOT (Strengths, Weaknesses, Opportunities and Threats) analysis or Force Field analysis

as appropriate to the level of application. The use of these tools by top management and the employees at MSI ensures that

the QMS can achieve its intended results, enhance desirable effects, prevent or reduce undesired effects, and achieve

improvement of the QMS.

6.1.2 Top management plans actions to address these risks and opportunities. The plans are identified in the ‘Risk Management

Plan’ and include how to integrate and implement the actions into the QMS processes.

Effectiveness of the actions taken are evaluated after completion and at the ‘Management Review’ (in relationship to

nonconformance’s, complaints, and other failures).

Actions taken to address risk and opportunities are proportionate to the potential impact on the conformity of services.

6.2 Quality objectives and planning to achieve them

6.2.1 Top Management, in order to support business objectives of broadening and diversifying the customer base, branching out with equipment/processes and increasing profitability has established ‘Quality Objectives’ at relevant functions, levels, and processes needed for the QMS. The ‘Quality Objectives’ are consistent with the ‘Quality Policy’, measureable, take into account applicable requirements, relevant to conformity of services and to enhancement of customer satisfaction, monitored, communicated, and updated as appropriate. Charts document the ‘Quality Objectives’ and the ‘Quality Objective Support Matrix’ maintains plans for achieving them.

The MSI ‘Quality Objectives’ are measurable whenever practicable. The ‘Quality Objectives’ are consistent with the MSI

‘Quality Policy’, taking into consideration its commitment to provide customers with the highest quality services and to meet

or exceed customer expectations. They are:

1. 100% on-time order delivery

2. Deliver all services free of any defects

MSI also tracks Productivity (weight/man-hour) for each week.

6.2.2 When planning to achieve the ‘Quality Objectives’, top management maintains a ‘Quality Objective Support Matrix’ to

document what actions are being done, what resources are required to do them, who is responsible for their accomplishment,

the actions’ due dates, and how to evaluate the results.


6.3 Planning of changes The MSI QMS ‘Quality Manual’ serves as the ‘Quality Plan’.

Changes to the QMS are planned and the implementation reviewed during the ‘Management Review’. Appropriate elements

of the ‘Quality Manual’ are reviewed and revised if major changes are made to the ‘Quality Plan’.

During the ‘Management Review’, top management considers the purpose of the changes and their potential consequences,

the integrity of the QMS, the availability of resources, and the allocation or reallocation of responsibilities and authorities.

7 Support

7.1 Resources

7.1.1 General Top management determines and provides the resources (people, equipment, facilities, etc.) needed for the establishment,

implementation, maintenance, and continual improvement of the QMS during the ‘Management Review’.

They consider the capabilities of and constraints on existing internal resources and identify what needs to be obtained from

external providers (consumables, utilities, calibration) when performing customer requirement reviews.

7.1.2 People Top management determines and provides the personnel needed for the effective implementation of its QMS during strategic

business planning sessions and the ‘Management Review’.

Personnel needed for the operation and control of its processes are also identified during ‘Customer Requirement Reviews’.

Effective use of recruiting and training services provide those resources.

7.1.3 Infrastructure MSI leadership determines, provides and maintains the infrastructure necessary for the operation of its processes and to

achieve conformity of its services.

They maintain a 14,000 square foot facility located at 85 Aldrich St., Providence, Rhode Island, 02905 for the receipt, heat

treatment, inspection, storage, and shipment of customers’ ferrous and non-ferrous metal. There is a 2,700 sq. ft. office located

at 94 Aldrich St.

Equipment used for these services include fluidized beds, carburizing, vacuum, and atmospheric furnaces, salt-baths,

induction heating equipment, test equipment (hardness, salt titration, etc.), surface finishing and cleaning stations.

Documents are managed on a computer using Word and Excel. Cooltreat software is used for process documents such

(Process Sheets, Shipping Labels, etc.) and Quickbooks is used for order and billing management.

7.1.4 Environment for the operation of processes MSI has determined that basic room temperatures and humidity are the environment necessary for the operation of its

processes and to achieve conformity of its services and maintains it through appropriate use of standard heating systems.

They provide a suitable environment that is a combination of human and physical factors, such as: temperature (heating and

cooling), light, ventilation, and hygiene.

Where needed, MSI has the ability to control the atmosphere within some furnaces.

7.1.5 Monitoring and measurement resources

7.1.5.1 General MSI has determined and provides the resources needed to ensure valid and reliable results when monitoring or measuring is

used to verify the conformity of services to requirements.

They ensure that the resources provided are suitable for the specific type of monitoring and measurement activities being

undertaken and maintained to ensure their continuing fitness for their purpose.

MSI retains the ‘Monitoring and Measuring Matrix’ as evidence of fitness for purpose of the monitoring and measurement

resources.


7.1.5.2 Measurement traceability When measurement traceability is a requirement, or is considered by MSI to be an essential part of providing confidence in

the validity of measurement results, measuring equipment is calibrated at specified intervals against measurement standards

traceable to international or national measurement standards. Where no such standards exist, the basis used for calibration

or verification is recorded.

MSI measuring equipment is logged in the ‘Measuring and Monitoring Equipment Matrix’ and a sticker is affixed to a piece of

measurement equipment shows its calibration status.

All equipment is safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and

subsequent measurement results.

Part of the MSI calibration and nonconformance system calls for validation of previous measurement results that may have

been adversely affected when measuring equipment is found to be unfit for its intended purpose, and take appropriate action

as necessary.

7.1.6 Organizational knowledge MSI has been in operation since 1989. Organizational knowledge specific to the operation of its processes and to achieve

conformity of its services is maintained in both electronic and paper media.

When considering changing needs and trends (during service and market analyses, ‘Management Review’, etc), top

management reviews its current organizational knowledge and determines the appropriate means to acquire or access any

necessary additional knowledge and required updates from internal and/or external sources.

The repositories of this knowledge include, but are not limited to:

KNOWLEDGE LOCATION

• User manuals

• Technical support documents

• Reference materials

Shop Office or Main Office

• Supply Chain Quickbooks

• Quality Manual

• Quality Objectives

• Management Review Minutes

• Process Sheets

Main Office

• Forms

• Process flow charts

• Customer Relationship Information

• Return Material Authorization Documents

Appropriate Folder on the Network

• Shipping data

• Process Sheets Cooltreat system

7.2 Competence MSI has determined the necessary competence of employees and sub-contractors working under its control that affects the

performance and effectiveness of the QMS. MSI ensures that they are all competent because of their appropriate education,

training, or experience. These contributing elements of competency are initially documented in the ‘Qualifications Required

for Employment by Roles Matrix’.

If new competencies are required, MSI, where applicable, takes actions to acquire the necessary competence, and evaluates the

effectiveness of the actions taken.

MSI retains an ‘Employee Training Matrix’ to be updated when competency requirements change and/or training, education,

or experience is acquired.

7.3 Awareness MSI provides training and periodic reviews to ensure employees are aware of the ‘Quality Policy’, relevant ‘Quality Objectives’,

and their contribution to the effectiveness of the QMS, including the benefits of improved performance and the implications

of not conforming to the QMS requirements.

This information is retained in the ‘Master Communication Plan’.


7.4 Communication MSI has determined the internal and external communications relevant to the QMS, including on what it communicates,

when to communicate, with whom to communicate, how to communicate, and who communicates.

This information is maintained in the ‘Master Communication Plan’.

7.5 Documented information

7.5.1 General The MSI QMS includes documented information required by ISO 9001:2015 including, but not limited to the ‘Quality Policy’,

and ‘Quality Objectives’. It also contains information determined by MSI as being necessary for the effectiveness of the

QMS such as the, ‘Master Communications Plan’, ‘Roles, Responsibilities, and Authorities Matrix’, ‘Master Document

Matrix’, or ‘Nonconformance Report’, ‘Corrective Action Request’, etc.

The flow chart of the ‘MSI Organization & Quality Management System’ provides the description of the inputs and outputs and interaction between the processes and the QMS.

7.5.2 Creating and updating MSI identifies documents with unique names summarizing the functions described. For some documents that describe

multiple versions of a function (ex. Process Sheet) a unique identification number is included.

Information is maintained in an appropriate format including electronic or printed documents.

When a change of a document is needed, the copy is marked-up with the intended changes, reviewed, and approved by the

appropriate authority. The new document is created, logged in the ‘Master Document Matrix’, stored in the appropriate

location with the needed security controls. While obsolete documents are appropriately disposed, marked-up copies are

retained for historical perspective in an ‘Obsolete’ folder in the ISO Network.

The Quality Representative or designee has the authority for final approval of documents and assigns a revision date to each

new or revised document (mm/dd/yyyy) and, whenever possible, it is noted in the document’s footer.

After approval, the documents are listed in the ‘Master Document Matrix’.

7.5.3 Control of documented information

7.5.3.1 MSI management may access “read only” or “form” documents on the ISO drive and appropriate sub-folders appropriate for

their use.

Production Control issues Process Realization documents (ex. ‘Process Sheet’, drawings, etc.) to the work area.

The electronic documents are password protected to prevent unauthorized modification.

7.5.3.2 MSI maintains a ‘Master Document Matrix’ for the control of documented information for the management of change control

(version control) through the ‘date-of-revision’ of the documents maintained on the list.

Documented information of external origin determined by MSI to be necessary for the planning and operation of the QMS is

identified on the ‘Master Document Matrix’ and controlled, as appropriate.

The ‘Master Document Matrix’ addresses the storage and preservation, retention and disposition of records maintained as

required by the QMS.

All documents retained as evidence of conformity to the QMS are protected in the Main Office or on the ISO Drive to allow

review but prevent unintended alterations.


8 Operation

8.1 Operational planning and control MSI plans, implements and controls the processes (see 4.4, Figure 1) needed to meet the requirements for the provision of

services and to implement the actions determined in Clause 6 (Actions to address risks and opportunities).

In determining the requirements for its services, MSI creates a ‘Process Sheet’ for each new job which includes customer

requirements and drawings, if necessary.

Criteria for processes and the acceptance of services are defined in the drawings, specifications or ‘Process Sheet’.

The quote documents and the supporting documentation are maintained and retained in the ‘Customer File’ to provide

evidence that processes have been carried out as planned and to demonstrate the conformity of services to their requirements.

MSI performs a customer requirement review to outline and describe the process and to control planned changes and review

the consequences of unintended changes, and taking action to mitigate any adverse effects, as necessary.

Outsourced processes are controlled, as necessary (see ‘MSI - Purchasing - Vendor Approval Process’ flow chart).

8.2 Requirements for products and services

8.2.1 Customer communication Customer feedback, including customer complaints are handled through e-mails or phone calls with the top management.

Customer complaints are documented in the ‘Complaints & Compliments’ folder on the ISO Network.

Communications regarding handling or controlling customer property and establishing specific requirements for contingency

actions, when relevant, are handled through the General Manager.

8.2.2 Determining the requirements for products and services Customer requirements are specified and determined at the time of order or request-for-quote (RFQ) by the customer with

top management or based on the customer Purchase Order (PO), including any special delivery requirements (see ‘MSI -

Customer RFQ - Order Entry Process’ flow chart).

Requirements not stated by the customer but necessary for specified or intended use, where known statutory and regulatory

requirements applicable to the service, and any additional requirements considered necessary by MSI are identified at this

time.

8.2.3 Review of the requirements for products and services

8.2.3.1 MSI conducts a quote review for all new orders received all other orders are repeat orders based on prior quotes. The purpose

of this review is to ensure that all orders are adequately defined and that orders, which are outside the capability of MSI to

produce are not to be accepted. The General Manager or designee enters the order into the ‘Cooltreat Database’. The General

Manager reviews the ‘Estimate’ to determine the consumable material availability.

Order acknowledgements are sent if requested (see ‘MSI - Customer RFQ - Order Entry Process’ flow chart).

8.2.3.2

MSI retains documented information or records in the ‘Quote File’ on the results of the reviews and on any new requirements identified or requested by the customer for services to be provided.

8.2.4 Changes to requirements for products and services If a purchase order’s requirements are changed, the General Manager would review the change, revise the quote and ‘Process

Sheet’, and notify the Production Supervisor who would ensure the appropriate changes are made on the floor.

8.3 Design & Development This is not applicable to the MSI QMS (see 4.3).


8.4 Control of externally provided processes, products, and services

8.4.1 General MSI ensures externally provided services conform to requirements (see ‘MSI - Purchasing – Vendor Approval Process’ flow

chart).

MSI has determined the controls to be applied to Vendors providing consumable material and additional services.

Top management has determined and applies the criteria of 1. Availability, 2. Price, 3. Quality, 4. Service for the evaluation,

selection, monitoring of performance, and re-evaluation of vendors.

MSI purchases consumable material and additional services only from ‘Approved Vendors’ in Quickbooks. Products and

vendors are reviewed for quality, price, availability and performance. Vendors and the consumables or services approved are

entered into Quickbooks.

MSI retains documented information of these activities and any necessary actions arising from the evaluations in the PO’s for

purchases from new vendors, in the ‘Approved Vendor List’, and in the ‘Management Review Minutes’.

Vendors that do not meet specifications delineated within their purchasing requirements may be considered for removal from

the ‘Approved Vendor List’ depending on the frequency or impact of the defect. Purchasing may take that action and review it

at the ‘Management Review’.

The Grandfathered Vendor Clause (good historical performance) is in effect as of 10/25/16.

8.4.2 Type and extent of control MSI has established and implemented the activities necessary for ensuring that purchased consumable material meets

specified purchase requirements as detailed in the ‘MSI - Purchasing – Vendor Approval Process’ flow chart.

Shipping/Receiving checks materials for identity/count against the Bill of Lading and for any damage. They put the material

away, sign the Packing Slip to indicate approval, and give it to the Office Manager for payment and filing in the ‘Vendor

Folder’ in the main office file.

MSI does not perform source inspections.

8.4.3 Information for external providers Purchasing information and requirements are detailed on either the purchase order or within a contract with vendors of

services or materials.

Review of purchase requirements and acceptance of purchase orders are performed per the ‘MSI - Purchasing – Vendor

Approval Process’ flow chart.

Purchase Orders are reviewed, where appropriate, for consumable materials and additional services, methods, processes and equipment, release of services, competence requirements, external provider’s interaction with MSI, control and monitoring of the external provider’s performance, and any needed source inspection that MSI, or its customer, intends to perform at the external providers’ premises.

Purchase orders are reviewed for completeness and accuracy by the Office Manager before they are sent to vendors.

8.5 Production and service provision

8.5.1 Control of production and service provision MSI implements service provisions under controlled conditions.

Documented information that defines the characteristics of the services to be provided, or the activities to be performed, are defined and detailed in the customer’s Purchase Order, ‘Process Sheet’ and the ‘Quote Folder’. The ‘Quote Folder’ includes the documented information on the results to be achieved.

The availability and use of suitable monitoring and measuring resources are identified on the ‘Monitoring and Measurement Matrix’. The implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for services, have been met are identified on the ‘MSI - Process Realization Process’ flow chart. In-process and final inspections are performed before release and delivery of service, including any post-delivery activities (if applicable).

MSI provides suitable infrastructure and environment for the operation of processes, including the appointment of competent persons. The ‘Training Matrix’ is maintained as the appropriate documented information retained as evidence of competence.


Process fool-proofing is applied to equipment or processes to prevent human error, if applicable.

Where the resulting output cannot be verified by subsequent monitoring or measurement, MSI validates those processes.

8.5.2 Identification and traceability MSI uses suitable means to identify outputs, when it is necessary, to ensure the conformity of service. Identification numbers on ‘Process Sheets’ are assigned to operations performed and are maintained throughout the heat treatment process.

Output released for shipping is identified by methods such as the Quality Release section on the ‘Process Sheet’.

‘Process Sheets’ and documented information in the ‘Customer Folder’ are used to identify the status of outputs with respect to monitoring and measurement requirements throughout heat treatment.

Where traceability is a requirement, MSI controls the service through a unique number on the ‘Process Sheet’ and the service for each lot is kept separate from other lots.

Records are maintained in the ‘Customer Folder’.

8.5.3 Property belonging to customers or external providers MSI exercises care with customer supplied property while it is under MSI’s control or being processed by MSI.

MSI identifies, verifies, protects and safeguards customer property provided for heat treatment.

If any customer property is lost, damaged, or otherwise found to be unsuitable for use, MSI reports this to the customer and

maintain records, including a ‘Nonconformance Report’. The customer is notified by email and records of the damaged or

unsuitable product are maintained in the ‘Customer Folder’.

8.5.4 Preservation MSI uses adequate methods of handling, storage, and packaging of materials and product to insure conformance to

specifications.

All components and product are protected from loss, deterioration, or contamination throughout the heat treatment process.

All components and product are protected from loss or damage while in storage at MSI.

All material is positively identified while in storage with a ‘Product Tag’ or ‘Hardness Tag’, and ‘Process Sheet’. All finished

product is packaged using materials meeting commercial or customer requirements (as necessary) while providing adequate

protection against cosmetic and environmental damage.

Delivery of material and finished product is done using the MSI truck or standard common carriers except where specified by

customer requirements.

Any material or finished product requiring special handling, storage, packaging, or delivery, is performed in accordance with

specified contractual agreements.

8.5.5 Post-delivery activities This is not applicable to the MSI QMS (see 4.3).

8.5.6 Control of Changes MSI reviews and controls changes for heat treatment provision, to the extent necessary to ensure continuing conformity with

requirements.

When trends in heat treatment indicate a need, specifications are reviewed and changes are made in the process sheets.

The General Manager authorizes any changes made and any action arising from the review of customer requirements when

new orders are received.


8.6 Release of products and services MSI implements planned arrangements, at appropriate stages to verify that the service requirements have been met.

When consumable materials or customers’ parts are received in, the Receiver checks materials as received for identity/count against the Bill of Lading and for damage. If damaged material is received it is documented with a ‘Nonconformance Report’ and the customer is notified.

The General Manager verifies damaged materials. The ‘Nonconformance Report’ is used to track vendor deficiencies.

Operators perform in-process checks during applicable process steps and results are recorded in the ‘Process Sheet’.

A Final inspection is performed before final release and documented in the ‘Process Sheet’. The release to the customer does not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by the Vice President and, as applicable, by the customer.

MSI retains documented information on the release in the Main Office files, including evidence of conformity with acceptance criteria and traceability to the person(s) authorizing the release.

8.7 Control of nonconforming outputs

8.7.1 Nonconforming customer parts and consumable materials identified at receiving are identified with a ‘Nonconformance

Report’. The customer or vendor is contacted to determine whether the material should be returned, disposed of or recycled.

For nonconforming output identified during heat treatment, or at packaging, the ‘Nonconformance Report’ is completed and

attached to the ‘Process Sheet’ and is immediately moved to the Factory Office (if small parts) or a designated hold area.

The Quality Manager or designee will follow-up with a completing a ‘Corrective Action Request’ if the defect is significant or

frequent.

When nonconforming output is detected after delivery to the customer, action appropriate to the effects, or potential effects,

of the nonconformity are taken. Customer complaints are handled by the General Manager and the product is returned for

rework or concessions are made. If the complaint warrants, as agreed upon with the customer, causes of the nonconformity

are investigated and corrective actions are taken and follow-up is performed to verify the effectiveness of the corrective

actions.

When nonconforming product is corrected it is subjected to re-verification to demonstrate conformity to the requirements.

A summary of nonconforming outputs is one of the ‘Management Review’ inputs and completed ‘Nonconforming Reports’ are

retained.

8.7.2 Records of the nature of nonconformities identified during the manufacturing process are maintained in the ‘Nonconformance

Folder’.

Records of the nature of nonconformities identified after delivery, and any subsequent actions taken, including concessions

obtained, are maintained in the ‘Nonconformance Folder’.


9 Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General MSI has determined what needs to be monitored and measured, the methods for monitoring and measurement, analysis and

evaluation needed to ensure valid results, and when the monitoring and measuring is performed.

The ‘Monitoring and Measurement Matrix’ serves as the plan for the implementation of the monitoring, measurement,

analysis, and improvement processes needed to demonstrate conformity of the service.

Internal audits are performed to ensure conformity of the QMS.

The results from monitoring and measurement of incoming materials or components and in-process or final service are

analyzed and evaluated before appropriate action (acceptance, rejection, ‘Nonconformance Report’ or ‘Corrective Action

Request’) is taken.

Top management evaluates the performance and the effectiveness of the QMS during ‘Management Reviews’ and the results

are noted in the ‘Management Review Checklist and Minutes’.

9.1.2 Customer satisfaction MSI monitors customers’ perceptions of the degree to which their needs and expectations have been fulfilled. MSI obtains

information through methods including, but not limited to, sales’ direct e-mails or phone calls, analyzing the trend of business

activity, and unsolicited customer feedback such as complaints or compliments.

If customer complaints are significantly severe or repetitive, a ‘Corrective Action Request’ will be issued without undue delay and verification of the actions taken will be reported to top management.

Evidence of customer satisfaction will be documented through customer letters, emails and/or customer surveys.

The information is one of the topics of the ‘Management Review’.

9.1.3 Analysis and evaluation The ‘Management Review Checklist/Meeting Minutes’ serve as the tool for the identification of the data that is collected and

analyzed to determine and demonstrate the suitability and effectiveness of the QMS and to evaluate where continual

improvement of the effectiveness of the QMS can be made. This includes data related to customer satisfaction, conformity to

service requirements, performance and effectiveness of the QMS, if planning has been implemented effectively, the

effectiveness of actions taken to address risks and opportunities, the performance of external providers, the need for

improvement to the QMS.

This information and other relevant sources is considered at the ‘Management Review’.

9.2 Internal audits

9.2.1 MSI conducts an internal audit of the entire QMS at least annually to provide information on whether the QMS conforms to

MSI’s own requirements and to the requirements of ISO 9001:2015 and to ensure the QMS is effectively implemented and

maintained.


9.2.2 The internal quality audit is used as a tool in determining the effectiveness of the QMS and adherence to work procedures.

Audits are conducted against the requirements of the ISO 9001:2015 International Standard and company procedures and

work instructions.

Internal Quality Audits are conducted by the Internal Quality Auditors or Authorized Contract Personnel to ensure objectivity

and the impartiality of the audit process. Internal Auditors cannot audit their own work.

The ‘ISO 9001:2015 Audit Checklist’ is used to conduct and document the Internal Quality Audit. If nonconformities or

opportunities for improvement are identified, they are documented on an ‘Internal Audit Report’. Corrective actions are taken

without undue delay and verification of the actions taken are reported.

Results of the audit and corrective action verification are communicated to top management. Records of the Internal Quality

Audits, captured with the ‘ISO 9001:2015 Audit Checklist’ and ‘Internal Audit Report’, are maintained as required.

9.3 Management review

9.3.1 General Top management reviews the QMS, at least semi-annually, to ensure its continuing suitability, adequacy, and effectiveness. This review includes assessing opportunities for improvement and the need for changes to the QMS, including the quality policy and quality objectives.

Top management utilizes a checklist approach to the ‘Review Inputs’ (9.3.2) and ‘Review Outputs’ (9.3.3).

Records of the ‘Management Review’ are maintained using the ‘Management Review Checklist/Meeting Minutes’.

9.3.2 Management review inputs The ‘Management Review Checklist/Meeting Minutes’ contains all of the items needed to be covered in order for top management to make an informed decision about the suitability, adequacy, and effectiveness of the QMS including, but not limited to (where applicable): status of actions from previous management reviews, changes in external and internal issues that are relevant to the QMS, information on the performance and effectiveness of the QMS, customer satisfaction and feedback from relevant interested parties, the extent to which quality objectives have been met, process performance and conformity of services, nonconformities and corrective actions, monitoring and measurement results; audit results, the performance of external providers, adequacy of resources, the effectiveness of action taken to address risks and opportunities; opportunities for improvement.

9.3.3 Management review outputs The outputs of the ‘Management Review’ include decisions and actions related to: opportunities for improvement, the need

for any changes to the QMS, and any resources needed to support it.

The ‘Management Review Checklist/Meeting Minutes’ serve as evidence of the results of ‘Management Reviews’.

10 Improvement

10.1 General MSI strives to continually improve the effectiveness of the QMS through the use of the ‘Quality Policy’, ‘Quality Objectives’, audit results, analysis of data, corrective actions, risk and opportunities identified and ‘Management Review’.

Top management works to improve services and to meet requirements as well as to address future needs and expectations. Potential opportunities to correct, prevent, or reduce undesired effects of services are identified during customer requirement reviews.

Internal Audits are conducted and the results are used for improving the performance and effectiveness of the QMS.


10.2 Nonconformity and corrective action

10.2.1 When a nonconformity occurs, including any arising from complaints, MSI reacts to the nonconformity and, as applicable,

takes action to control and correct it and deals with the consequences.

The ‘Corrective Action Request’ has sections in it that call for a: Description of the nonconformity, determination of the extent

of the nonconformity in terms of the service, process, area, or organizations involved that may need to be part of the

corrective action, determination of the root cause(s) of the nonconformity, the corrective action(s) to take and the

effectiveness of those actions, the impact on risk management, any needed changes to the QMS, and any other any other

required follow-up.

The area responsible for the nonconformity will determine and implement the corrective actions.

Corrective actions taken are appropriate to the intensity or frequency of the nonconformities found.

10.2.2 Completed ‘Corrective Action Requests’ are retained as evidence of the nature of nonconformities and subsequent actions to

address them as well as the results of the corrective actions.

A summary of corrective actions is one of the ‘Management Review’ inputs.

10.3 Continual improvement MSI continually improves the suitability, adequacy and effectiveness of the QMS.

Top Management uses the Management Review Inputs and Management Review Outputs sections of the ‘Management Review

Checklist/Meeting to determine the suitability, adequacy and effectiveness of the QMS and to evaluate where continual

improvement of the effectiveness of the QMS can be made.

The result is listed in the ‘Management Review’ outputs.


Addendum A - Customer RFQ – Order Entry Process


Addendum B Purchasing – Vendor Approval Process




Addendum C Process Realization