Authorised by Quality Manager BUSINESS MANAGEMENT SYSTEM 1 - Quality Manual... · BUSINESS MANAGEMENT SYSTEM ... BS EN ISO 9001: AS9100 cross – reference . Title ... BSEN9100-Rev

Amphenol Limited Issue No: 19 Page 1 of 38

BUSINESS MANAGEMENT SYSTEM

Authorised by Quality Manager Date: 4 January 2016

This document, if printed is for information only, it is the users responsibility to ensure use to latest revision available on the intranet. The contents of this document remain the property of Amphenol Ltd. This document contains confidential proprietary information, and shall not be copied, disclosed, reproduced or used for any other purpose; unless written permission is granted by Amphenol Ltd. Amphenol Ltd retains the right to request the prompt return of this document.

OUR MISSION To be the first choice supplier of interconnect-based solutions to our target markets




CONTENTS – BS EN ISO 9001: AS9100 cross – reference

Title

ISO 9001: 2008 BSEN9100-Rev

C Reference Ref Page

Quality Manual Ref Page

Procedures Ref Page Work

Instructions Cover page and mission statement 1 Systems documentation and reference 2 Quality Manual Distribution 4 Quality Manual Revision Record 5 Quality Policy 5.3 7 Scope and Company Profile 8 Quality References and Terms and Conditions 8 Quality Management system 4.2.2 9 Process Map and List 4.2.2 10 Process List 4.2.2 11 Control of Records and Documents 4.2.3 - 4.2.4 12 P-QA-007 WI-QA-016/005 Management Responsibility Commitment

5.1 / 5.5.1 / 5.5.2 13 P-QA-019

Customer Focus 5.2 13 P-QA-018 Company Organisation 14 Quality Planning 5.4.2 15 P-QA-017 Quality Objectives 5.4.1 16

Internal Communication 5.5.3 16 P-HS-016 Management Review 5.6 17 P-QA-019 WI-QA-013 Independent Test House 18 Provision of Resources Provision of Resources Flow Chart

6.1 / 6.2.1 / 6.2.2 / 6.3 / 6.4 19

P-QA-011 P-QA-017 WI-HR-003/004

Planning of Product Realisation and Flow chart 7.1 / 7.2 22 P-QA-011 Product Realisation 23 Project Management 7.1.1 / 7.2 24

WI-PRJ-001

Risk management

7.1.2 24 P-QA-016

WI-PRJ-001 WI-ENG-005 WI-ENG-028




Configuration management 7.1.3 25 P-QA-003 WI-ENG-008 Control of Work Transfers 7.1.4 25 P-QA-020 Customer Communication 7.2.3 25 P-QA-018 Determination of Requirements Related to Product 7.2.1 26 P-QA-004

WI-ENG-001 WI-ENG-005 WI-ENG-028

Review of Requirements Related to the Product

7.2.2 26 P-QA-004

WI-PRJ-001 WI-ENG-005 WI-ENG-028

Design Process 7.3 / 7.3.1 / 7.3.2 / 7.3.3 / 7.3.4 / 7.3.5 / 7.3.6 / 7.3.7 27 P-QA-006

WI-ENG-001-005

Purchasing Process 7.4.1 / 7.4.2 / 7.4.3 28 P-QA-014

WI-PCH-001-003

Product Process Verification 7.5.1.1 28 P-QA-011 Control of Production and Services Provision

7.5.1 / 7.5.2 / 7.5.3 / 7.5.4 /

7.5.5 29 P-QA-011 Control of Production Process Change 7.5.1.2 29 P-QA-003 WI-ENG-002 Identification and Traceability 7.5.3 30 P-QA-011 Customer property 7.5.4 30 P-QA-018 Preservation of product 7.5.5 30 P-QA-011 Control of Monitoring and Measuring Devices 7.6 31 P-QA-002 WI-QA-003 Monitoring and Measurement of Process 8.2.3 31 P-QA-011 WI-OPS-002 Monitoring and Measuring of Product 8.2.4 31 P-QA-011 WI-OPS-002 Customer Satisfaction 8.2.2 32 Internal Audit 5.2 32 P-QA-009 WI-QA-007 Control of Non Conforming Product 8.3 33 P-QA-012 WI-QA-008 Continual Improvement 8.5.1 33 P-QA-018 Improvement 8.4 34 P-QA-018 Corrective Action 8.5.2 35 P-QA-005 WI-QA-026 Preventive Action

8.5.2 35 P-QA-013 WI-QA-026 WI-ENG-028

Foreign Object Damage (FOD) Policy

37




DISTRIBUTION Internal Hard copy (Quality Manager) All employees Intranet




REVISION RECORD

QMS Ref Page # Revision

Approved Rev #

Date DCR Ref

Quality Manual 4 Update issue status. I.S 2 02/02/2010 2679

Quality Manual 7 Insert after 'Managing Director': '(or in the MD's absence a nominated alternative Director)'.

I.S 2 02/02/2010 2679

Quality Manual 7 Replace Para with the following: 'The Nottingham office provides part of the technical design and support to our Whitstable manufacturing site. The Nottingham office specialises in Aero Engine Connectors, Rail Connectors and their associated assemblies.'

I.S 2 02/02/2010 2679

Quality Manual 10 Generate a new box in parallel with the 'Sun Contract Control’ box, labelled 'Supplier Selection and Approval'.

I.S 2 02/02/2010 2679

Quality Manual 13 Replace Org chart with latest management team chart.

I.S 2 02/02/2010 2679

Quality Manual 4 Add '(REV B)' after AS9100 in the column header. Add '(REV C)' after '7.1.2' and '7.1.3'.

I.S 3 08/02/2010 2680

Quality Manual 5 Remove reference to QinetiQ. Update issue status.

I.S 3 08/02/2010 2680

Quality Manual 6 Replace 'all. Managing' with 'all, - managing'. Replace 'Employee. In' with 'Employees - in'.

I.S 3 08/02/2010 2680

Quality Manual 9 Replace 'customer of' with 'or customer'. I.S 3 08/02/2010 2680

Quality Manual 12 Remove ' from 'commitments'. Replace 'to on a regular basis' with ', on a regular basis to'.

I.S 3 08/02/2010 2680

Quality Manual 12 Replace 'establishes' with 'established'. I.S 3 08/02/2010 2680

Quality Manual 14 Add in full stop and capital after 'importance' and awareness'. Remove hyperlink to 'Customer Satisfaction'.

I.S 3 08/02/2010 2680

Quality Manual 16 Replace 'Test House Procedures' hyperlink with 'Calibration'.

I.S 3 08/02/2010 2680

Quality Manual 17 Replace 'work and inspection' with 'work, inspection'.

I.S 3 08/02/2010 2680

Quality Manual 17 Replace 'recources' with 'resources' I.S 3 08/02/2010 2680

Quality Manual 18 Replace title 'Planning' with 'Custom Related Process Communication'.

I.S 3 08/02/2010 2680

Quality Manual 24 Remove hyperlink 'Inspection and Testing'. I.S 3 08/02/2010 2680

Quality Manual 24 Replace 'in' with 'is' I.S 3 08/02/2010 2680

Quality Manual 27 Replace 'AS9100 C' with 'AS9100 B' I.S 3 08/02/2010 2680

Quality Manual 28 Remove hyperlink 'CSIP' I.S 3 08/02/2010 2680

Quality Manual All Update issue number and DCR number on each page.

I.S 4 23/02/2010 2698

Quality Manual 5 Add line to issue status as follows 'a 23.02.10 DCR2698'

I.S 4 23/02/2010 2698

Quality Manual 6 Add 'REV B' after 'AS9100'. Replace '2000' with '2008' I.S 4 23/02/2010 2698

Quality Manual 7 Add extra sentence as follows: 'All Quality Management System Documentation is available for review by Customers and the Regulatory Authorities'.

I.S 4 23/02/2010 2698

Quality Manual 7 Replace sentence on exclusions with 'There are no exclusions to the content of ISO 9001:2008. Para 7.5.1.5 (Control of Service Operations) of AS9100:REV B is excluded.'

I.S 4 23/02/2010 2698




Quality Manual 20 Replace Para and diagram with following: 'Configuration Management is covered by the four basic functions Item Identification, Change Control, Database, and Configuration Audits prior to release. Configuration control is managed through the Engineering Database within the MAPICS Business Management System.'

I.S 4 23/02/2010 2698

Quality Manual 20 Add the following hyperlinks: 'Contract Review, Design, Document and Record Control, Release Documentation'.

I.S 4 23/02/2010 2698

Quality Manual 16 Change 'Specific responsibilities of the Director of Quality (defined as Executive responsible for Quality) and the Technical Products and Approvals Manager (defined as CECC System Manager) are as defined in BS EN 100114-1 and 2' to ' Specific responsibilities of the Director of Quality (defined as Executive responsible for Quality) and the Designated Management Representative(s) are as defined in IEC QC 001002-3.'

I.S 5 14/06/2010 2723

Quality Manual 16 At the end of the sentence add 'and in accordance with the Test House Manual, 123GB-0347.'

I.S 5 14/06/2010 2723

Quality Manual 4 & 5 Add Revision Record for all DCR’s raised against the Quality Manual. I.S 6 27/07/2010 2734

Quality Manual

All relevant

pages All changes to Quality Manual by DCR’s to be highlighted in Bold Italics I.S 6 27/07/2010 2734

Quality Manual 16

Change ‘designated management representative(s)’ to ‘CESS Systems Manager (or DMR, Designated Management Representative)’ I.S 7 05/08/2010 2741

Quality Manual 9 Add details of Level 4 addition to QMS I.S 8 21/09/2010 2745

Quality Manual 2 Update contents page. Configuration management, insert 4.3(Rev B) I.S 9 24/03/2011 2798

Quality Manual 16 Replace ‘as defined in QC 001002-3’ with ‘as defined in IEQC 03-1’ I.S 10 06/04/2011 2803

Quality Manual 6 Update Quality Policy accordingly I.S 11 20/09/2011 2831

Quality Manual All Review quality manual in line with requirements of revision C I.S. 12 09/03/2012 2872

Quality Manual 10 & 11 Update process map and list to include Purchasing and reword Despatch to Packing Despatch I.S. 13 21/05/2012 2894

Quality Manual All General review of Quality Manual to ensure process approach is achieved I.S. 14 30/06/2012 2914

Quality Manual All Make minor adjustments as per DCR documentation T.H 15 24/01/2013 2959

Quality Manual 34 Change statement of Continual improvement and detail of activity T.H 16 18/04/2013 2978

Quality Manual All Various Minor Amendments and inclusion of FOD Policy p38 T.H 17 26/01/2014 3022

Quality Manual 14 & 16 Organisation Chart and Company Objectives T.H 18 09/03/2015 3070

Quality Manual All Annual Review , Title change and various minor amendments T.H 19 04/01/2016 3110




QUALITY POLICY

Amphenol Ltd Quality Policy is:

“Customer Satisfaction Through People Dedicated to Excellence”

1. Our Goal is to exceed our customer expectations through the quality of our products and services. This is achieved through our drive for continuous improvement in quality, cost and delivery.

2. Quality and Quality Improvement is every Amphenol employees’ responsibility and ultimate goal.

3. Our directives, processes, systems and goals are based on requirements from International standards, the expectations of our customers, our knowledge and experience. Knowledge of and compliance with these directives and processes is the foundation of our improvement activities.

4. Preventing failures is more important than stopping defects. We apply methods and tools from preventative Quality Assurance in a systematic way, learning from opportunities to eliminate root causes without delay.

5. Our suppliers contribute substantially to the quality of product and services, therefore, our suppliers must live up to the same high quality standards we have adopted.

6. Communication and employee empowerment is the cornerstone of our principles; this is accomplished by our ongoing commitment to training and our employees’ direct involvement in continuous improvement.

Our Business Management System will meet the requirements of:

BS EN AS9100: Rev C ISO 9001: 2008

S Roberts Managing Director




SCOPE

The purpose of this Business Management System is to formally document the company’s quality management system in order to demonstrate the company’s quality systems, planning and top management involvement. It is also a working tool to instruct and guide all employees on the relationships between system processes and product quality and to inform customers of any additional, agreed, quality requirements. The contents of the Business Management System may not be copied or duplicated in any form or made available to any third party without prior consultation with the Quality Manager. All Quality Management System documentation is available for review by customers and the regulatory authorities. If this manual, or part of it, becomes damaged or lost it must be reported immediately. Amphenol LTD reserve the right to deviate from any procedure contained within this manual subject to approval by the Managing Director [or in the MD’s absence] a nominated alternative Director as long as there is no breach of any imposed legal or regulatory requirements. COMPANY PROFILE

Amphenol UK Operations is an innovative and leading edge manufacturer of both connectors and interconnect systems for applications within the Mil-Aero, Telecom, and Industrial markets. Our products cover technologies within both fibre optic and copper products. Specific recent solutions incorporate signal conditioning, electro-optic transceivers and line protection units. Cabled systems utilise over moulding and open loom manufacture of both copper and fibre products. Our UK Operations consists of two divisions with 150,000 square feet of manufacturing space, allowing Amphenol UK to supply the world with a diverse range of interconnect solutions. The Whitstable location manufactures Military and Avionics, RF connectors, Filter/EMP products, Fibre Optics, Cable Assembly and Hermetic products. The Nottingham office provides part of the technical design and support to our Whitstable manufacturing site. The Nottingham office specialise in Aero Engine connectors, Rail connectors and their associated assemblies. Note on Exclusions There are no exclusions to the content of ISO 9001:2008 or AS9100 Rev C NORMATIVE REFERENCES

AS9100 Quality Management Systems – latest revision status ISO 9001 Quality Management Systems – latest revision status TERMS AND DEFINITIONS

For the purposes of this document the Terms and Definitions of AS9100 and ISO 9001 apply




QUALITY MANAGEMENT SYSTEM General Requirements The Business Management System documentation has 4 levels to its structure. The four levels comprise: Level 1 - this manual which systematically sets out to describe from an overview how the quality system is achieved. Figure 1 shows the general plan of processes which shows the sequence and interaction of the process Level 2 - procedures describe the main processes and include any regulatory or customer certified procedures. It is the function of level 2 procedures to set out the control of activities within each department and control the actions between each department. The level two documentation is when required supported by instructions, drawings, flowcharts, data cards and methods of manufacture as appropriate for individual processes (this list is not exhaustive). Level 3 - controlled documentation comprises of specific work instructions, manufacturing data, reference documents, visual standards, flowcharts etc. Level 4 – Controlled documentation blank forms with reference to work instructions and general requirements as detailed The overall function of the business management system is to establish documented criteria by which all activities within the company affecting quality are planned, deployed and maintained. The Business Management System shall enhance customer satisfaction, providing a frame-work for continuous improvement. Standards/Legislation Where the quality system, product or service is required to comply with national or international standards, legislation, customer specific or defence, requirements, controlled copies of the relevant documents will be retained. These may relate to the company as a whole, particular products or markets. During the contract review stage consideration shall be given to any special regulatory requirements.




Process Map

Busin

ess

Plan

ning

/St

rate

gy

Info

rmat

ion

Tech

nolo

gy

Inte

rnal

and

Ex

tern

al

Com

mun

icat

ion

Qua

lity

Man

agem

ent

Pers

onne

l De

velo

pmen

t/Tr

aini

ng

Hum

an

Reso

urce

Pl

anni

ng a

nd

Cont

rol

Fina

nce

Depa

rtm

ent

Corr

ectiv

e an

d Pr

even

tive

Actio

n

Cont

rol o

f Non

Co

nfor

min

g Pr

oduc

t

Docu

men

t Co

ntro

l

Insp

ectio

n an

d Te

st

Manufacturing

Core

Pro

cess

es

Deliv

ery

Supporting Process

Management Process

Input Results

Packing and Despatch

Order Processing Contract Review

Purchasing

Provision of Resources

Design




Process List

Process Name Process Owner Process Effect Measures

Order Processing / Contract Review Sales and Marketing Manager/ Finance Director

Customer Concerns PPM Quote Turn Around Time

On Time Delivery

Purchasing Purchasing Manager On Time Delivery

CAR Response Time Supplier PPM

Design Technical Director On Time Delivery

Customer Returns Specific to Design Press Log

Provision of Resources Human Resources Manager Staff Turn Over Ratio Absence Monitoring

Manufacturing / Process Operations Director

Scrap % of Revenue Number of Concerns

Cost of Quality On Time Delivery

Customer Concerns PPM

Packing and Despatch Operations Manager Customer On Time Delivery Customer Concerns PPM




Control of Records and Documents All drawings, specifications and quality documents used within the scope of the Business Management System are subject to issue control and authorisation. Standards such as International Standards that are held by the company are retained with an index of all standards being maintained. The retention of quality records shall be achieved in such a manner that no significant deterioration of the records will take place and that any customer and regulatory requirements are met

Prior to destroying records, permission must be gained from the Quality Management Representative. All records shall be retained for 10 years unless otherwise specified by contract or regulation. Customers with signed contractual agreements must be notified prior to the destruction of any records.




MANAGEMENT RESPONSIBILITY Management Commitment The Managing Director has direct responsibility for quality, having the authority and responsibility of ensuring that the quality programme is implemented and maintained. He shall ensure that at all appropriate levels, the commitment to quality is understood throughout the organisation; He is committed, on a regular basis, to review the following areas:

• Quality Management System • Management Responsibility • Resource Management • Product Realisation • Measurement, Analysis and Improvement

The Quality Manager is the appointed Management Representative, with responsibility for the maintenance of the quality system and has the freedom and unrestricted access to higher levels of management in order to resolve quality management issues. He ensures that all processes are established and compliant with any legal requirements imposed by regulatory bodies and that agreed customer requirements are complied with. The Quality Manager reports directly to the Managing Director and has responsibility as follows:

• Ensures maintenance and implementation of required and existing Business Management System processes.

• Reports to top management and management team on the performance of Business Management System the need for any improvement

• Ensures the promotion and communication of customer requirements throughout the company at appropriate levels.

Customer Focus Amphenol Limited is committed to ensuring that customer requirements are met and we exceed their expectations. The senior management team ensure that our customer requirements are clearly communicated. The management team will ensure that product conformity and on time delivery performance are measured and reviewed ensuring that appropriate action is taken if planned results are not or will not be achieved




Company Organisation Top level organisation is shown below; all individual quality management system responsibilities are contained within related procedure and policies. It is accepted also that appropriate delegation of authority can be given to an appointed representative.

Steve RobertsGeneral Manager

Wendy MorganAdministration Supervisor /

P.A. to GM

Laura SmithHuman Resources Manager

George MummeryManufacturing

Engineering Manager

Graham DowleSales Director

TBAOperations Director

Tony HollandQuality Systems Manager

Suzanne ButcherFinancial Controller

Steve FowlerTechnical Director

Claire TyeOperations Manager




Quality Planning Quality planning is the responsibility of the senior management team who define and document how the responsibilities for quality within the company will be met. Plans will be consistent with our quality system, and documented to suit our method of operation, whilst ensuring at all times that customer requirements are met. Satisfaction of these requirements is achieved by effective implementation of all processes and related Quality Systems procedures and work instructions in day to day activities. Quality system planning and reviewing is performed prior to the addition of significant changes that may have an impact on Amphenol Limited’s, Business Management System in order to minimise the risk of negative effects. Business Management System Model

Communication and flow of information is of vital importance. This can be demonstrated as an integrated part of processes that require customer awareness. The process model above demonstrates the overview of this process.

Continuous ImprovementEmployee induction

Notice boardsTraining

Measurement analysis dataQuotes

ContractsFeedbackQueries

ConcessionsMeetings

Defined responsibilityManagement review

Quality objectives

Team involvementSales

DesignProduction

QualityPurchase

Administration

Communication

INPUT

Forms planned arrangements

OUTPUT




Quality Objectives Amphenol Limited’s senior management ensure that quality objectives are flowed down and communicated to all levels of the organisation, performance to these objectives are communicated to all Amphenol Limited’s employees on a regular basis by senior management. In addition, performances to the key defined objectives are reviewed at the management reviews. In the absence of any overriding contractual requirements the safety and reliable of the product will be considered and addressed.

Goal Review Frequency Responsibility

Customer Concerns Monthly Quality Manager

Customer P.P.M Reject Ratio Monthly Quality Manager

Supplier P.P.M Monthly Quality Manager

Scrap Ratio Monthly Operations Director

On Time Delivery Monthly Operations Director

Order Intake Monthly Sales Director

Revenue Monthly Finance Director

Not Right First Time Monthly Manufacturing/Production

Managers Internal Communication Amphenol Limited ensures that the performance and effectiveness of the Quality Management System is shared in the following ways: • Company Intranet • Employee team briefs – Managing Director • Performance data posted on visual management boards • Accessibility to Fracas Database for the status of corrective and preventative action




Management Review Management review of the Business Management System is carried out at monthly intervals via the Amphenol Limited monthly Ops Review and is used as a tool in order to monitor the effectiveness of the system. An annual Quality Management Review may be carried out where specific concerns need to be addressed. Each review shall have a process approach with defined review of input and subsequent outputs. Management Review Model

Management Review Meeting

Corrective actionsPreventive actionsCustomer feedback

Internal audit resultsProcess performance data

Training needsResource needs

PoliciesProcedures

Business changesPrevious meeting actionsBusiness and quality plan

Quality objectivesKPI

Performance information

AS9100ISO9001

Polices and proceduresQuality manual, procedures

Work instructionsCustomer/regulatory requirements

Management review minutes

Improvements to systems and processesEnhanced customer satisfaction

Set actions for improvements to take placeResource needs identified for group

Management Review Team:Managing Director

DirectorsSenior Managers

INPUT

OUTPUT




Independent Test House Note: The test house is an independent facility and is mentioned here for reference only.

The Test and Environmental Compliance Manager with responsibility for test house functions reports to the Technical Director.

The boundaries, authorities and responsibilities of the Test House are summarised as follows:

• Qualification Approval and Maintenance of Approval testing for all MIL-DTL (DESC) and proprietary products, including liaison with the various approval authorities and the preparation and submission of reports.

• Carrying out mechanical, electrical and environmental testing associated with the development and

approval of Amphenol Ltd’s product range.

• Operation of the Test House as an Independent Approved Test House as defined in accordance with the Test House Manual, 123GB-0347.




PROVISION OF RESOURCES The Managing Director shall ensure that sufficient physical resources and personnel are available to undertake required management, performance of work, inspection, test and auditing activities. Individual managers identify the need for such resources and personnel, and ensure that when available they are either deployed or employed effectively and consistently. All employees involved in management, performance of work and verification activities that have a discernible effect on the quality of product or service provided for the customer shall be trained to an appropriate level of competence as determined by the planning of the defined processes or associated to process objectives. The level of competence shall be such that customer requirements and satisfaction can clearly be met. Each functional manager is responsible for the identification of training competence requirements for all employees whose work in any way affects the quality of the product or maintenance of the quality system. All employees will receive induction training, which incorporates an explanation of the company’s:

• Quality Policy Statement • Health and Safety and Environmental Policies • The company mission and vision • Key departmental and any specific objectives and key performance indicators

Amphenol Limited considers and addresses many differed aspects of the work environment

• Facilities • Health & Safety • Environment laws and regulations • Housekeeping • Special working conditions – i.e. ESD / Lighting, Authorised, Access, Environmental controls

Additionally Amphenol Limited ensured that for new procedures or significant changes to an existing process consideration is given to:

• Workspace • Associated facilities for the workspace • Equipment required • Services for support




Process Flow Chart: Provision of Resources Process Owner: Human Resources Manager

Requirements defined by department heads based on business

requirements

Is additional labour required?

Request submitted to senior management team for approval

Is request Approved

Internal and External vacancies posted

Are applicants acceptable

Hire personell

End

Probation review Quality induction

Health & Safety induction

Skills matrixOngoing performance appraisal

TrainingTerminate employment Do hires meet objectives set?

Yes

No

Yes

No

Yes

Input

Process Effectiveness Measure- Absence monitoring

- Staff turn around ratio

Output




PLANNING OF PRODUCT REALISATION Customer Related Process Communication Planning of product realisation is achieved via the review of the customer requirements in conjunction with the existing known capacity and programmed work, all new work is reviewed via the contract review process. Contract Review and Order Processing Process Process Owner: Sales and Marketing Director

Receive Customer Order

Check for existing Quote

Computer generated Part Code

Customer Drawing No. quoted

Release / Certification requirements

Any other requirements, items and conditions not

shown above

Check Price file for Contract Pricing

Raise IMR(WI-ENG-012)

Check Amphenol Cross Ref. screen, if any

discrepancies raise CDCWI-ENG-004

As per WI-QA-022

Check with Sales Mgmt / QA / Contract / Finance /

Marketing / ECO

NO

All checks complete for Contract Review

(P-QA-004) - sign Order Sheet / Stamp

Print off Order Acknowledgement

Check Order Acknowledgement

against Customer order

File office copy with Customer order

Send top copy of Order Acknowledgement to

customer

Key into Computer

NO

Coordinator checks – New Order /

Amendment or Confirmation?

Check Details (Add Ack No)

Coordinator carries out Contract Review (P-QA-004)

which incorporates the following:

NEW ORDER / AMENDMENT CONFIRMATION

INPUT

Process effectiveness measures

- Quote turn around time- On time delivery

- Customer Concerns PPM

OUTPUT




Product Realisation In order to ensure products comply with the defined requirements, the process of Product Realisation is summarised as below: Manufacturing Process Process Owner: Operations Manager

Demand Created by MRP Contract Review Customer Order

Schedules released and orders printed

Material issed drawn or manufactured in accordance

with order requirements

Components and required parts for orders are kitted

Floor stock items selected by operators

Product manufactured in accordance with production

documentation

Parts are packed

In process inspection / testTo define characteristics

Are parts required for an external

customer?Book parts to stock

Book parts to stock

Process to stores or next department as defined on the

router

Run and Print pick list

Pick parts

Pack and despatch parts with C of C to customer

Process Effective Measure- Scrap % revenue- On time delivery

- Customer concerns – PPM- Number of concerns

- Cost of quality

Feeder Areas Assembly Areas

No

Yes

INPUT

OUTPUT




Product Realisation (Continued) Packaging and Despatch Process Owner: Operations Manager

Is product for an external customer?

Book parts to stock

Demand from customer

Run pick list

Pick Parts

Any special requirements

detailed on certificate of conformance?

Ensure C of C is signed by authorised signatory and relevant action is taken

Package and despatch parts with signed C of C to customer

Process Effectiveness Measure- Customer Concern PPM

- Cost of Quality - Customer On Time Delivey

Yes

INPUT

OUTPUT

No




Project Management Effective product management is the cornerstone of Amphenol Limited mission to ensure that our strategic direction is focused on achieving new business opportunities that are released to market with customer requirements for quality cost and delivery are fully released. The project management process defines design, development and qualification phases of product development in order to control, coordinate and track the project status. Risk Assessment Amphenol has established a process for managing risk in order to ensure that the applicable requirements are met in relation to the organisation and product. Amphenol Limited has formulated a business continuity plan “The Red Book” to ensure continuity of supply to our customers in the event of significant disruptions to our manufacturing customer service process. The Risk Management process is defined as below: Risk Management Overview

Identify Risk Risk CommunicationRisk ControlsRisk MitigationDefine Risk Type

Internal Risk

Quality Design Planning

Management

Inform internal departments of risk

and actions

Business Continuity plan

D-FMEAP-FMEA

Improvement Plans

Internal business case

Customer concession

Preventive action

Contract reviewDesign review

Production Management

review

External Risk

CustomerSales

QualityManagement

Supplier

Customer complaintSupplier

conformance

Inform customer of risk and actions

Supplier development

activities

Risk management plan for customer




Configuration Management Overview Configuration Management is covered by the four basic functions, below:

1. Item Identification 2. Change Control 3. Database 4. Configuration Audits, prior to release

Configuration control is managed through the Engineering Database within the MAPICS Business Management System. Control of Work Transfers If business needs dictate that work is to be transferred outside of Amphenol’s approved manufacturing facilities, this process will be facilitated under control conditions ensuring that all customer specific requirements are adhered to at all times. Amphenol may outsource when required calibration and maintenance this is completed in accordance with approved source change process. Customer Communication Formal communications channels are established and maintained between Amphenol Limited and our customers to ensure that customer requirements are fully realised. Internal communications are established and maintained between sales & marketing, project management, engineering, quality assurance and operations to ensure that customer requirements are known and fully understood at all times. In relation to objectives for quality cost and delivery, the contract review procedure ensures that this requirement is met.




Determination of Requirements Related to the Product Prior to the acceptance of a contract the customer requirements are defined and communicated to the responsible or affected functions e.g.

• Project Management • Design Engineering • Operations • Quality Assurance • Sales & Marketing • Continuous Improvement • FOD / Foreign object elimination prevention. Amphenol will develop programmes geared

at awareness and training of all employees. In order to ensure proper documentation of all requirements and importantly to determine if they can be met. Review of Requirements Related to the Product The scope of work and all customer requirements and associated risks are fully understood and if necessary clarify with the customer. Any discrepancies between the contract and the order are resolved before acceptance of the contract.




Design Where components, products or systems are required, and are outside the scope of our standard products they will be subjected to our design process. All new designs are subjected to final sign off approval prior to release to production. This approval for product released is dependent on sign off and approval by the Quality Assurance and Operations Director Process Flow Chart: Design Process Owner: Technical Director

Design Input

File for each new design project should contain- Design input data- Design functional requirements- Design Plan- Design review of data and results- Design change and respective ECN- Customer proposal drawings- Joint engineering tasks (JET)- Project action requests (PAR)- Design and process FMEA (If applicable)

Design Plan

Design Activity

Design review including review of outputs

Design verification

Approve for sign off to productiong

INPUT

OUTPUT

Process Effectiveness Measure- On time delivery

- Customer returns specific to designed products

- Production request for engineering (Log)




Purchasing Sub contractors and suppliers will be selected on the basis of cost, delivery, technical competence and including their ability to meet and maintain quality requirements in accordance with pre defined criteria, this criteria is defined by both commercial and quality assurance departments

Before a new sub-contractor is used for the purchase of goods, material or service, they will be fully evaluated to establish suitability. Existing suppliers will be evaluated on an ongoing basis, to ensure development and improved performance, Process Flow Chart: Purchasing Process Owner: Purchasing Manager

Tender Process for Key New Project Requirement

identified by the buyer

EndIs approval given by Purchasing Manager

Pre tender presentation compiled WI-PCH-003

New vendors complete NDA financial checks

Review quotations on receipt

Does Vendor have AS9100 / ISO9001?

Complete new vendor request form

Does vendor pass manufacturing capability

assessment?Vendor refused

Vendor added to approved vendor listFlow down specific requirements, supplier

quality manual which is P-SQA-021, Amphenol T&C of purchase and

FAIR requirements

Process Effectiveness Measure- On time delivery

- CAR response time- Supplier PPM ratio

No

Yes

No No

Yes Yes

INPUT

OUTPUT




Control of Product and Service Provision Processes for the manufacturing, inspection, verification test are identified and carried out under controlled conditions to ensure the quality of product and services. Documented procedures defining these processes are provided by means of drawings, specifications, workmanship standards, process and manufacturing instructions. Inspection and test is conducted at specific points during the manufacturing process. Manufacturing routers provide evidence that all manufacturing and inspection/verification operations have been completed. Controlled conditions also include as applicable:

• Accountability of all products during production (e.g. part quantities, split orders, non conforming product)

• Provision for the prevention, detection and removal of foreign objects. Product Process Verification A representative item from each production run is used to verify that production process, documentation is capable of maintaining product quality. First article inspection is performed in compliance to AS9102 Control of Product Process Change Production process changes are controlled, documented and approved by process engineering/design engineering requirements and quality assurance department and where applicable by either the regulatory authority or customer. Results of these changes are assessed to confirm that there is no affect on product conformity.




Control of Production Equipment

Product equipment, tools and software programs used to control/monitor production realization process, are validated prior to release and are maintained. Product equipment, tools and software programmes are maintained and inspected periodically. Storage equipment including preservation checks are established for production equipment or stored tooling.

Identification and Traceability

Amphenol Limited maintains the identification of the product by way of coding product with a unique Amphenol Whitstable reference ‘AMB’ in addition to part description and week of manufacture. Traceability is maintained to unique batch number referencing for example, unique serial numbers, date codes and part descriptions to determine the source of material used to build the product. Appropriate records are maintained for the retrieval of the traceability of delivered/manufactured product.

Customer Property

All customer property shall be identified verified and stored in a manner so as not to cause any deterioration or compromise its intended use. Customer property is also the provision of intellectual property including but not limited to:

• Drawings • Specifications • Electronic data

All Documents, Records, gauging, stamps or other customer supplied products is to be returned on notification from the customer or when business with the customer has ceased. Preservation of Product The movement, protection and identification of materials is the responsibility of the relevant departments where material reside, this responsibility includes the safe handling and protection of materials and products during transfer between departments. Secure storage is provided for the isolation and protection of materials and goods pending use or despatch. At regular intervals stock levels are assessed for accuracy along with deterioration where appropriate stock rotation shall apply. All goods despatched by the company are suitably packed to withstand all expected commercial handling conditions en route. Where there is contractual packaging requirement this will be met during contract review.




Control of Monitoring and Measuring Devices All equipment within the company that is used for the purpose of test and measurement is subject to a periodic test of its accuracy. All equipment is therefore maintained to a known standard with records for each piece of equipment being maintained. The frequency of calibration is defined within the database of records for each piece of equipment. The system is worked so as not to allow any piece of equipment to be out of calibration. Monitoring and Measurement of Process Amphenol Limited processes are monitored to ensure their continuing ability to achieve planned results. If planned results are not achieved corrective action is taken. In the event of process non conformity, appropriate actions are taken to correct the non conforming process, evaluate whether the process non conformity has resulted in product non conformity, if this is the case then the relevant remedial action is taken in accordance with Amphenol Limited non conformance control and corrective and preventative action process. Monitoring and Measuring of Product The extent and sequence of inspection and tests are specified in documented procedures, including process and manufacturing instructions in order to demonstrate that specified requirements are met. The amount and nature of the inspection or test required is completed to ensure that the specified requirements are met. Sampling inspection in accordance with statistical sampling plans may be used when required.




Internal Quality Audits The Quality Manager is responsible for ensuring that the requirements of the Quality Management System are effective and implemented. A programme of audits will be scheduled, on the basis of status and importance, to ensure that each process in every part of the organisation is subject to an audit at least once per year and more frequently where appropriate. A plan of audits will be produced at the start of each year.

The audits will take into account the company quality management systems and the requirements of BS EN ISO 9001: 2008 and AS9100 C. The Audit shall take a process approach with the scope based around the process, and controlling documentation. With the output objective of process based improvements via the identification of non-conformance or opportunities for improvement. Internal Audit Model Auditors shall be competent Internal audit practitioners and have appropriate knowledge of ISO9001 and AS9100 standards appropriate to their auditing scope. A trained auditor independent of the area being assessed will complete audits, as appointed by the company.

Objective evidence

Audit planPrevious audit findings

Outstanding corrective actionInternal audit procedure

Quality ManagerAudit Team

Auditee

Audit Process

QMS improvement action request trends

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Control of Non Conforming Product Processes to control the movement and segregation of non conforming goods ensure that goods that do not meet the required specification are clearly identified and segregated to prevent unauthorised usage, despatch or mixing with conforming goods. Non conforming goods received from a supplier are clearly identified and segregated with documentation being raised to record the nature of the fault and to accompany the goods back to the supplier. Continual Improvement The Managing Director along with the company management team are committed to the activity of continuous improvement. This can take the form of audit results, corrective/preventative actions, analysis of data etc to improve current process or drive key discussions out Management Review. Continuous Improvement Model

ContinuousImprovement

Q.C.D

Audit resultsCustomer complaints

Internal rejectsScrap

Corrective actionPreventive action

Customer feedbackSupplier feedback

Management reviewMeasurement analysis Improvement

Team InvolvementManaging Director

ManagersSales

ProductionQuality

AdministrationCustomersSuppliers

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Improvement Key to the organisation is the effective use of measurement and analysis and Improvements, this is achieved via the identification of Objectives and targets along with key performance information. This activity is summarised in the list and process model below: Customer satisfaction Conformance to product requirements Characteristics of processes, product and trends Suppliers performance Business objective improvement Continuous Improvement This list is not limited. See process model below: Measurement Analysis and Improvement Model

PDCAMeasurement Analysis

Product / Process System Improvement

Management teamCustomer

Customer satisfactionInternal audits

Process measurementsProcess effectivenessProduct measurementCustomer complaints

Internal rejectsKey characteristicsQuality objectives

Corrective/preventiveBusiness quality plan

Management reviewMeasurement analysis Improvement

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Corrective/Preventive Action Amphenol Limited have established a corrective and preventative action system used for the recording and analysis of quality related problems to determine trends and root cause of non conformances. The system is used for the tracking of corrective and preventative actions in order to measure effectiveness. Corrective/preventative action may be as a result of internal, customer system or product audits, customer and internal reject or the results of the management review. Amphenol will ensure that all products in the value stream affected by the concern will be identified and actioned in accordance with Amphenol corrective and preventive action procedures. Corrective Action Requests for corrective action can be in the form of:

• Audit non conformance reports • Supplier quality corrective action request • Customer return note • Internal/external Fracas report

These maybe submitted to the process owner or supplier for the identification of root cause to initiate the appropriate corrective action. The originator ensures that the necessary corrective action request is in place ensure that the corrective action request is closed in a timely manner. Routine quality activity centre held where status of corrective action reviewed escalation invoked to senior management team if corrective action is not actioned appropriately Preventative Action Non conformances are analyzed to determine the preventative actions needed, this analysis may include a review of dispositions of non conforming batches, operations during internal and customer audits, internal and customer rejects. The depth of this analysis is dependent upon the criticality of the non conformance in relation to quality, cost, delivery and safety. Relevant information on preventative actions taken may be submitted for the management review process.




Corrective/Preventive Action Model

Implement Root CauseEffective Action

Product Non-conformanceProcess Non-conformance

Customer ComplaintInternal Audit Non-conformance

Potential problems

Corrective action procedurePreventive action procedure

Internal auditsNon conformance procedure

Change control

Elimination ofProducts/process

Non conformances

Management teamCustomerSuppliers

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FOREIGN OBJECT DAMAGE POLICY All Amphenol products shall be protected from damage attributed to a foreign object that could cause potential damage and /or failure. Most Foreign Object Damage (FOD) can be attributed to poor housekeeping, facility deterioration and improper care during assembly and/or manufacture. An effective FOD prevention program identifies potential problems and provides effective awareness and employee training.

Definitions

Foreign Objects Debris: (FOD) Any substance, fragment or rubbish alien to an item that could potentially cause damage.

Foreign Object Damage: (FOD) Any damage attributed to a foreign object that can be expressed in physical or economic terms which may or may not degrade the products safety and/or performance characteristic.

Potential FOD: The condition where foreign object debris may cause damage and/or failure should the product be put into use. Examples of Potential FOD in the workplace include: • Wire clippings • Solder Balls • Solder Wire cuttings • Debris lying around on work bench (Use of abrasive substances such as Emery Cloth/sandpaper is NOT to

be used on product assembly benches or where cross contamination could cause a potential FOD issue. • Used Components • Metal burrs • Shavings • Oil and Chemicals • Dust on Machines/ Rubbish on floors • The use of Card board boxes • Packaging and WIP Containers containing any of the above • Airborne debris (Debris from vents / extraction systems or overhead structure. • Debris/Shavings being transferred to other departments (cross contamination)

FOD Critical Areas: Defined within Amphenol Ltd as: - an area where the manufacture, assembly, testing, storage or despatch of an Amphenol product takes place. All incidents of actual or potential FOD shall be investigated and reported to management or line supervision. Actual incidents shall also be recorded on the FRACAS system.

Internal Audits Internal Audits of FOD Critical Areas shall include a FOD assessment of the area, and ensure that 5C requirements are being adhered too. Areas which fail to maintain a strict FOD control regime will be reported to the SMT.

Food and Drink Food and drinks are not to be consumed at the work stations in FOD Critical Areas.




Training FOD training shall be given during the induction of all employees to the company by the Quality Manager. Further training shall be carried out to increase employee awareness on a regular basis and it should cover the causes and effects of FOD. It is required for all employees and contractors and shall be maintained and updated on an ‘as required’ basis. The training is to cover the following topics: • Causes and effects of FOD • Clean as you go principles • Housekeeping and formal 5C practices Housekeeping It is the responsibility of employees to maintain a clean and orderly work area. Clean as You Go practices shall be employed to prevent FOD migrating into products, WIP packaging and other areas where damage may be caused. All employees should ensure the work area is clean: • Prior to starting an operation • As an operation progresses and work debris accumulates • When an operation cannot continue • At the end of shift • If you drop something or hear something drop –pick it up! • Bench tops shall not shed particles (to avoid damaging product and FOD) Note: The 5C Method for improving workplace organisation using controls (i.e. Clearout, Configure, Clean & Check, Conformity, and Culture), has a positive impact on FOD prevention! Product Protection A FOD Barrier should be used to protect components that are exposed to potential damage. Connectors shall have protectors, caps, plugs, and protective covers used to seal-off and provide protection once built. Staples are not to be used on any WIP Packaging or final product packaging. Design Considerations The reduction of damage potential and elimination of FOD hazards should be taken into consideration when carrying out any of the following: • Factory layouts • Moving of equipment • Identification and elimination of potential foreign objects areas • Setting up work benches • 5C practices and events • Component packaging • Jigs and Fixtures Contractors All Contractors working on site shall be made are aware of the FOD policy when carrying out the following: • Working in a FOD critical area and what requirements are required. • Cleaning of floors and machines. • General Maintenance to machines and facilities. • New installations.