INFORMATION ONLY

Cleanzone

Technology Ltd.

QUALITY MANUAL

Dungarvan, Co. Waterford

~NFORMATION ONLY

REVISION mSTORY

03

Update as per recommendations from Pre-Audit on 18th Aug 2009

Sept 2009

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INFORMATION ONLY

TABLE OF CONTENTS

Section

Title

Page

1. SCOPE
1.1 General ·lof3
1.2 Application 20f3
2. References lof1
3. Terms and Defmitions lof1
4. Quality Management Systems lof4
4.1 General Requirements lof4
4.2 Documentation Requirements 30f4
4.2.1 General 30f4
4.2.2 Quality Manual 30f4
4.2.3 Control of Documents 30f4
4.2.4 Control of Records 40f4
5. Management Responsibility lof6
5.1 Management Commitment lof6
5.2 Customer Focus lof6
5.3 Quality Policy 20f6
5.4 Planning 20f6
5.4.1 Quality Objectives 20f6
5.4.2 Quality management system planning 30f6
5.5 Responsibility, authority and communication 30f6
5.5.1 Responsibility and authority 30f6
5.5.2 Management Representatives 40f6
5.5.3 Internal Communication 40f6
5.6 Management Review 50f6
5.6.1 General 50f6
5.6.2 Review Input 50f6
5.6.3 Review Output 50f6
6. Resource Management lof3
6.1 Provision of Resources 10f3
6.2 Human Resources lof3
6.2.1 General 10f3
6.2.2 Competence, training and awareness 20f3
6.3 Infrastructure 20f3
6.4 Work Environment 30f3 7. Product Realization 1 of 7

7.1 Planning of product realisation lof7

7.2 Customer-related processes 1 of 7

7.2.1 Determination of requirements related to the product 1 of 7

Section

Title

Page

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TABLE OF CONTENTS

7.2.2 Review of requirements related to the product 20f7

7.2.3 Customer communication 30f7

7.3 Design and Development 30f7

7.3.1 Design and development planning 30f7

7.3.2 Design and development inputs 30f7

7.3.3 Design and development outputs 30f7

7.3.4 Design and development review 30f7

7.3.5 Design and development verification 30f7

7.3.6 Design and development validation 3 of 7

7.3.7 Control of design and development changes 3 of 7

7.4 Purchasing 3 of 7

7.4.1 Purchasing process 3 of 7

7.4.2 Purchasing information 4 of 7

7.4.3 Verification of purchased product 4 of 7

7.5 Product and service provision 4 of 7

7.5.1 Control of production and service provision 4 of 7

7.5.2 Validation of processes for production and service provisionS of 7

7.5.3 Identification and traceability 5 of 7

7.5.4 Customer property S of 7

7.5.5 Preservation of product 6 of 7

7.6 Control of monitoring and measuring equipment 6 of 7

8. Measurement, analysis and improvement 8.1 General

8.2 Monitoring and measurement 8.2.1 Customer Satisfaction 8.2.2 Internal Audit

8.2.3 Monitoring and measurement of processes 8.2.4 Monitoring and measurement of product

8.3 Control of nonconforming product 8.4 Analysis of data

8.S Improvement

8.S.1 Continual Improvement 8.S.2 Corrective Action

8.S.3 Preventative Action

8.6 Corrective Action 8.7 Preventative Action

10fS 10fS 10fS 10fS 20fS 30fS 30fS 30fS 40fS 40fS 40fS 40fS 40fS 40fS S of5

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Cleanzone Technology Ltd. Quality Manual
Document Ref: 1.0 Scope Revision: 03
Date: 18 Sept 09
Page: Page 1 of3 1.0 SCOPE

1.1 General

Cleanzone Technology's mission statement is - To be the best, versatile, high tech, technically competent company with a huge emphasis on customer service and satisfaction through Quality, Right First Time and being a Team Player.

a) Product and services offered by this organisation consistently meet the customer and applicable legal requirements, and

The Directors of Cleanzone Technology Ltd fully support the need for a comprehensive and effective quality management system to ensure that the:

. b) Enhancing customer satisfaction through the effective application of this system, including processes for continual improvement of the system whilst maintaining conformity to customer and applicable legal requirements.

1.2 Application

The Quality management system is designed to operate within the requirements of ISO 9001 :2008. In applying the requirements of this Standard, any clauses that are not applicable to this organisation due to the nature of the organisation's business are excluded from the scope of this quality management system. Such exclusions are described more fully under section 7.0 Product Realisation.

The requirements of this quality manual extend to all staff and establish a Quality Standard for the provision of services outlined herein:

INFORMATION ONLY

Cleanzone Technology Ltd. Quality Manual
Document Ref: 1.0 Scope Revision: 03
Date: 18 Sept 09
Page: Page 2 of3 Cleanzone Technology Ltd is a service company geared to service the industrial and commercial sectors as set out below:

The company is divided into two divisions as follows:

Maintenance

Cleanzone Technology Ltd will provide maintenance to the plant in two ways:

(a) Permanent Engineers and Technicians on-site under the supervision of the Client or appointed supervision by Cleanzone Technology Ltd.

(b) Contracted planned preventative maintenance visits. It is of the utmost importance that the quality of air going to a clean room is maintained. We plan to maintain this air with regular mechanical and electrical checks on the air handling units and associated equipment supplying air to these rooms. We have pre-determined checks that will, if carried out, keep the units running at 100% for 12-week intervals. The filters on these units will be checked and replaced when necessary. Both primary and secondary filters have a limited lifetime and that is monitored using the differential pressure across both filters.

Other equipment will be L.P. Hot water pumps and chilled water pumps, DX refrigerant split units i.e, air conditioning units. A full report will be furnished to the client on completion.

The objective at all times is that the site will be maintained to the highest preventative maintenance standards, in order to achieve the best possible effectivity availability of the equipment.

· 'NFORMATION ONLY

Cleanzone Technology Ltd. Quality Manual
Document Ref: 1.0 Scope Revision: 03
Date: 18 Sept 09
Page: Page 3 of3 Cleanroom and Equipment Validation Execution

The clean room is a modem phenomenon. What is a clean room?

The ISO 14644-1 standard, defines it as "A room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimise the introduction, generation and retention or particles inside the room and in which other relevant parameters, e.g. temperature, humidity· and pressure are controlled as necessary."

The validation execution section of Cleanzone Technology Ltd will perform all appropriate tests to ensure that the above parameters are met and maintained. This will involve testing of HEP A filters, which filter the air entering the room. This is called HEPA Filter Integrity Testing and is carried out using an aerosol challenger in conjunction with a state of the art photometer to analyse the readings. Taking particle counts readings, i.e. reading the amount of particles that are in the air, this is carried out using a particle counter. The differential pressure between the areas will be checked; the differential pressure across the filters will be checked. The temperature and humidity will be checked. Air changes will be calculated and air movement checked and Lux readings taken.

Compressed air, breathing au and nitrogen gas testing will be performed in accordance with customers' cGMP and applicable legal requirements'.

All of the above tests will be performed to the classification the clean room was designed to and a report will be issued with the findings.

INFORMATION ONLY

Cleanzone Technology Ltd. Quality Manual
Document Ref: 2.0 Normative Revision: 03
References
Date: 18 Sept 09
Page: Page 1 of 1 2. NORMATIVE REFERENCES

The following documents were used as reference during the preparation of the Quality Management System:

• National Standard ISO 9000-2008 - Quality Management Systems - Fundamentals and Vocabulary

• National Standard ISO 9001-2008 - Quality Management Systems - Requirements

• National Standard ISO 9004-2000 - Quality Management Systems - Guidelines for Performance Improvements

INFORMATION ONLY

Cleanzone Technology Ltd. Quality Manual
Document Ref: 3.0 Terms and Revision: 03
Definitions
Date: 18 Sept 09
Page: Page 1 of 1 3. TERMS AND DEFINITIONS

Throughout this quality manual, wherever the term 'service' IS used it means HV AC maintenance or validation service.

• Customer owned property - Any type of instrumentation, equipment and tools that belong to a Cleanzone Technology Ltd.

• Customer supplied product - Any type of service or material supplied to Cleanzone Technology Ltd to be utilized in the provision of the service to customers.

• Service - Throughout this quality manual, wherever the term 'service' is used it means BV AC maintenance or validation service.

• Quality Records - Documentation of those activities wherein records of the activities must be maintained will be specified in a standard operating procedure or work instruction level documents, as applicable

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Cleanzone Technology Ltd. Quality Manual
Document Ref: 4.0 Quality Revision: 03
Management Systems
Date: 18 Sept 09
Page: Page 1 of4 4. Quality Management Systems

4.1 General Requirements

Cleanzone Technology Ltd which was formed in November 2001 shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of ISO 9001 :2008. A copy of the company's quality policy is attached in Appendix 1 and the quality objectives are outlined in section 5.4.1.

Cleanzone Technology Ltd aims to enhance customer satisfaction through the effective application of the quality management system including the processes for continual improvement of the system and the assurance of conformity to customer and applicable legal requirements.

Our aim to be The Best will be reflected in the standard of our work and in the safe and efficient way we carry out this work. This Quality Manual outlines the work we perform and the quality management system implemented.

Cleanzone Technology Ltd shall

a) Determine the processes needed for the quality management system and their application throughout the organisation. The processes necessary for the effective and efficient operation of the organisation are defined within this quality management system and are subject to continuous assessment for their suitability and use. These include processes for management activities, resource planning and allocation, product and service realisation and performance measurement as well as outsourcing and contracting of key personnel. Cleanzone Technology LTD will embrace all the principles of current Good Manufacturing Practices

INFORMATION ONLY

Cleanzone Technology Ltd. Quality Manual
Document Ref: 4.0 Quality Revision: 03
Management Systems
Date: 18 Sept 09
Page: Page 2 of4 (cGMP) and adhere to our clients Quality System and the requirements of the Food and Drug Administration (FDA), and the Irish Medicines Board (IMB).

b) Determine the sequence and interaction of these processes as well as their contribution to the organisation's performance. These are defined by the use of organisational process flow charts within the quality management system. Please refer to Appendix 2 for the organisational flow charts.

c) Determine the criteria and methods needed to ensure that both the operation and control of these processes are effective. To achieve this, standard operating procedures, method statements as required, controlled validation and maintenance sheets and training programmes and appropriate measurement criteria are implemented and maintained. A list of all standard operating procedures and controlled validation and maintenance sheets are enclosed in Appendices 3 and 4.

d) Ensure the availability of resources and information necessary to support the operation and monitoring of these processes. For the effective operation and monitoring of key services, the necessary resources including in-house and outsourced personnel, equipment, material and information are determined, planned and provided for by management. Please refer to Appendix 2 for the organisational flow charts and SOP 12.0006 Management of Outsourced personneL

e) Monitor; measure and analyse these processes where applicable .. To understand the process performance, appropriate methods are in place for measuring, monitoring, analysis and feedback as well as reporting of data through organisation as outlined in sections 8.2 and 8.4.

f) Implement actions necessary to achieve planned results and continual improvement of these processes. To achieve target and sustained improvement, necessary management action are identified, planned and implemented. Actions

INFORMATION ONLY

arising from management reviews are implemented to achieve desired results as well as continual improvements of these processes.

Cleanzone Technology Ltd. Quality Manual
Document Ref: 4.0 Quality Revision: 03
Management Systems
Date: 18 Sept 09
Page: Page 3 of4 4.2 Documentation Requirements

4.2.1 General

The quality management system includes a documented statement of the company's quality policy attached in appendix 1 herein, quality objectives, a quality manual, standard operating procedures as outlined in Appendix 3, reports provided to customers and service level agreements determined by the organisation to be necessary to ensure the effective planning, operation and control of its processes. Please refer to Appendix 1 for the Company's Quality Policy.

4.2.2 Quality Manual

This defines the scope of the quality management system relevant to ISO 9001:2008 standard with appropriate exclusions as well as the organisation policies, process interactions and organisational structure. It also refers to established quality procedures and processes. The scope is the 'provision of HV AC maintenance and cleanroom and equipment validation and compressed air, breathing air and nitrogen gas testing services in accordance with customers' cGMP and applicable legal requirements' .

4.2.3 Control of Documents

The Standard Operating Procedure 'SOP on SOPs' 11.0001 defines the process for the approval, review, issue and maintenance of quality management system documents.

INFORMATION ONLY

Cleanzone Technology Ltd. Quality Manual
Document Ref: 4.0 Quality Revision: 03
Management Systems
Date: 18 Sept 09
Page: Page 4 of4 New or revised controlled documents are reviewed and approved for adequacy prior to issue, training and distribution. Current documents are available throughout the company as outlined in the SOP on SOPs 11.0001. Obsolete documents are identified and stamped obsolete and withdrawn to prevent inadvertent use and to ensure that all employees are working from the current correct documents. Customer specifications and procedures are controlled at the customers' site.

4.2.4 Control of Records

Quality records are taken to mean all quality documentation including the quality manual, standard operating procedures, validation and maintenance sheets, calibration records, training records, management reviews, audit reports, copies of all validation and maintenance reports in hard and soft format and associated DVD's and customer files. All quality records are held for 10 years after which time they may be destroyed. Quality records are stored on site in the document store and are readily identifiable and easily retrievable. All documents issued to clients by Cleanzone Technology Ltd are controlled by stamp as outlined in SOP on SOPs 11.0001. Training records are controlled as per Training SOP 12.0003. Training records of employee site inductions for intended works are controlled by the customer.

INFORMATION ONLY

Cleanzone Technology Ltd. Quality Manual
Document Ref: 5.0 Management Revision: 03
Responsibility
Date: 18 Sept 09
Page: Page 1 of6 5.1 Management Commitment

5. Management Responsibility

The Directors of Cleanzone Technology Ltd commits to enhance the quality management system by demonstrating the commitment to leadership and involvement in the quality improvement programme.

This includes involving all employees through effective teamwork and communication to achieve strategic quality objectives and overall company goals through:

(a) Communicating to the employees the importance of meeting customer and

legal requirements

(b) Developing, approving and promoting the company's quality policy (c) Ensuring that quality objectives are established and measurable

(d) Conducting management reviews

(e) Ensuring the availability of resources such as personnel, equipment and material for sustained service capability and improvement.

5.2 Customer Focus

The Directors of Cleanzone Technology Ltd are responsible for ensuring that customer requirements are determined and fulfilled and meeting those requirements with the objective of enhancing customer satisfaction.

In order to understand and meet customer requirements, management need to:

• Identify the customer and establish their current and future needs through discussion and annual contract review and site visits

• Document and communicate these requirements into understood and realistic requirements. These may include service and process requirements required by

INFORMATION ONLY

Cleanzone Technology Ltd. Quality Manual
Document Ref: 5.0 Management Revision: 03
Responsibility
Date: 18 Sept 09
Page: Page 2 of6 the Customer's quality system and legal requirements, timing, delivery and resource requirements as identified and documented in the service level agreements and/or method statements.

5.3 Quality Policy

5.4.1 Quality Objectives

The quality policy of Cleanzone Technology Ltd will be implemented and maintained through the company training programme which will ensure that it is understood operated and implemented throughout the organisation. A copy of the Company's Quality Policy is enclosed in Appendix 1.

5.4 Planning

The following are Cleanzone Technology's quality objectives for 2009 as agreed at the Management Review

• To provide a high standard of service to all our customers and ensure a customer satisfaction ~9%

To develop a website to capture a broader customer base requiring maintenance and cleanroom validation

• To generate customer feedback during annual contract review and ensure any

issues and improvements are identified and implemented

• To increase our client base by achieving ISO 9001 :2008 certification

• To improve our service by focusing our continuous improvement efforts on maintaining and expanding our client base

• To ensure all customer requirements as outlined in the Service Level Agreements are met

INFORMATION ONLY

5.4.2 Quality Management System Planning

Cleanzone Technology Ltd. Quality Manual
Document Ref: 5.0 Management Revision: 03
Responsibility
Date: 18 Sept 09
Page: Page 3 of6 In planning or revising the quality management system, management defines the processes for its operations in order to fulfil their stated quality objectives effectively and efficiently as outlined in section 5.4.1

The result is to establish, document, implement and maintain a quality management system that complies with the quality policies including those for continual improvement.

When changes to the quality management system are planned and implemented, management ensures through the management review and document control processes that such changes do not affect the integrity and operation of the quality management system.

5.5.1 Responsibility and authority

5.5 Responsibility, authority and communication

The Directors of Cleanzone Technology Ltd have a responsibility to define and communicate the responsibility and authority of employees in relation to quality. This will enable them to contribute to the achievement of the company quality policy and quality objectives and increase their participation/involvement and commitment.

All employees have a responsibility for the quality of services provided by the company. The responsibility of all employees in the management, performance and verification of work affecting the business operation and the effectiveness of the quality management system are documented in job descriptions and relevant

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Cleanzone Technology Ltd. Quality Manual
Document Ref: 5.0 Management Revision: 03
Responsibility
Date: 18 Sept 09
Page: ' Page 4 of6 procedures. These are communicated to employees through training. Please refer to Appendix 2 for organisation chart.

5.5.2 Management Representatives

The organisation's Quality Management representative is the Managing Director. Irrespective of other responsibilities, he has defined responsibility and authority to:

• Ensure that the requirements of ISO 9001 :2008 standard and the quality management system processes are implemented and maintained.

• Ensure all employees adhere to the quality systems and procedures referenced within the quality manual

• Manage, monitor and evaluate the performance of the quality management system

• Promote awareness of customer requirements throughout the company

• Communicate the processes of the quality management system and their effectiveness to all employees in the company

5.5.3 Internal Communication

The effectiveness of the quality management system is continually reviewed and reported throughout the company by means of communication processes which may include team meetings, training and e-mails.

INFORMATION ONLY

Cleanzone Technology Ltd. Quality Manual
Document Ref: 5.0 Management Revision: 03
Responsibility
Date: 18 Sept 09
Page: Page 5 of6 suitability, adequacy and effectiveness.

This review shall include assessing

5.6 Management Review

5.6.1 General

Cleanzone Technology Ltd is committed to achieving a sustained and continual improvement of quality at all levels in the company. This will be realised through the implementation and maintenance of the quality management system.

The Directors of Cleanzone Technology Ltd shall review the status and performance of the quality management system at planned intervals to ensure its continuing

opportunities for improvement and identify the need for changes to the quality management system, including the quality policy and quality objectives and records of management reviews will be recorded on the management review form F -0020.

5.6.2 Review Input

The input to management review shall include information on:

• Results of audits

• Customer feedback including compliments, queries and customer complaints

• Service performance and conformity

• Status of non conformances, corrective and preventative actions

• Follow-up actions from previous management reviews

• Changes that affect the quality management system

• Recommendations for improvement

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Cleanzone Technology Ltd. Quality Manual
Document Ref: 5.0 Management Revision: 03
Responsibility
Date: 18 Sept 09
Page: Page 6 of6 5.6.3 Review Output

The output from the management review shall include any decisions and actions related to:

(a) Improved effectiveness of the quality management system and its processes (b) Improvement of the service in relation to customer requirements

.,

( c) Resources requirements

(d) Revised quality and business objectives

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Cleanzone Technology Ltd. Quality Manual
Document Ref: 6.0 Resource Revision: 03
Management
Date: 18 Sept 09
Page: Page I of3 6. Resource Management

6.1 Provision of Resources

The organisation shall determine and provide the resources needed to

a) Implement and maintain the quality management system and continually improve its effectiveness and

b) Enhance customer satisfaction by meeting customer requirements

Employees shall be selected on the basis of their ability, training and experience. The majority of personnel shall be sourced in-house, if any additional personnel are required, their selection procedure shall be in line with company policy.

6.2 Human Resources

6.2.1 General

The quality management representative shall be responsible for ensuring that all employees are fully aware of the requirements of the Quality Management System.

All new staff shall be inducted to the Company Safety Statement and Quality Manual upon starting employment. The Directors. shall monitor closely any new employees and shall provide assistance and advice should it be required.

All employees performing work affecting conformity to service requirements shall be competent on the basis of appropriate education, training, skills and

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Cleanzone Technology Ltd. Quality Manual
Document Ref: 6.0 Resource Revision: 03
Management
Date: 18 Sept 09
Page: Page 2 of3 expenence as outlined in the Training SOP 12.0003. It shall be company policy to encourage continual professional development (CPD).

6.2.2 Competence, training and awareness

The company shall:

a) Determine the necessary competence for all employees performing work affecting conformity to predefined tasks or functions

b) Develop training plans with appropriate assessment to ensure competence of employees

c) Develop training plans to ensure complete familiarity with all requirements of the work processes, standard operating procedures

d) Ensure all employees are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives

e) Review the training needs for all employees periodically but at a minimum annually to take account of changing circumstances and requirements

f) Maintain appropriate records of education, training, skills and experience of all employees.

6.3 Infrastructure

The Directors of Cleanzone Technology Ltd shall determine, provide and maintain the infrastructure required to achieve conformity to service requirements. Infrastructure shall include

a) Buildings, workspaces and associated utilities

b) Process and test equipment and tools.

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Cleanzone Technology Ltd. Quality Manual
Document Ref: 6.0 Resource Revision: 03
Management
Date: 18 Sept 09
Page: Page 3 of3 c) Supporting services such as transport (company vans), communication (mobiles phones) and information systems (laptops) and overnight allowances.

6.4 Work environment

The company will define suitable work environmental conditions for staff to enable them to maximise organisational performance. This includes on site work activities and required training activities assessed and reviewed with clients.

Requirements for the work environment are detailed in the Company Safety Statement.

INFORMATION ONLY

The planning of service must consider the following:

a) Quality objectives and the requirements of the process. This shall include the capability of equipment and training and competence of employees.

b) The determination of any additional processes, documents, equipment, or resources that may be required to complete the service.

c) Required verification, validation, monitoring, inspection and test activities specific to the equipment and service provided and the criteria for acceptance

d) Records needed to provide evidence that the equipment and completed service meet requirements.

Cleanzone Technology Ltd. Quality Manual
Document Ref: 7.0 Product Realization Revision: 03
Date: 18 Sept 09
Page: Page 1 of7 7.0 Product Realization

7.1 Planning of Product Realization

7.2.1 Determination of requirements related to the product

7.2 Customer-related processes

Cleanzone Technology Ltd is responsible for:

a) Identifying the customer requirements for the service. These include the requirements specified by the customer (i.e, job description, delivery requirement and post delivery services)

b) In the event that some requirements are not stated but are necessary for the intended use of the customers' processes such as statutory and regulatory requirement related to the services provided, these requirements are to be communicated to relevant parties by any appropriate means.

c) Any additional requirements specified by Cleanzone Technology Ltd are identified and communicated to the customer

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Cleanzone Technology Ltd. Quality Manual
Document Ref: 7.0 Product Realization Revision: 03
Date: 18 Sept 09
Page: Page 2 of7 7.2.2 Review of the requirements related to the product

Cleanzone Technology Ltd reviews the customer requirements before work is accepted. All of the customer requirements are recorded on a quotation and discussed with all employees as appropriate.

(a) The product requirements must be defined and recorded and include at least the following:

• Contact name

• Customer N arne

• Work description

• Delivery Dates(s) - dates of intended start, completion and duration of work

• Pricing

• Customer address

• Invoice address

• Purchase Order

(b) Any difference between the quotation or proposal or work description as stated by the customers, Cleanzone Technology Ltd employees should identify requirements and notify either of the Directors.

(c) Ensure the availability of employees and resources necessary to meet the requirements of the intended work

Where a customer order is received by verbal means, and no written statement of requirements is available, the order requirements shall be verbally agreed before their acceptance.

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Cleanzone Technology Ltd. Quality Manual
Document Ref: 7.0 Product Realization Revision: 03
Date: 18 Sept 09
Page: Page 3 of7 On the receipt of a purchase order management shall carry out a further review where applicable to ensure:

The stated requirements are in conformance with the proposed work Any discrepancies found shall be notified to the customer

7.2.3 Customer Communication

The management shall determine and implement effective arrangements for communicating with customers in relation to

a) Service information

b) Enquiries, contracts, order handling including amendments

c) Customer feedback including customer complaints.

7.3 Design and Development

Cleanzone Technology Ltd has no design function and so this clause does not apply to the company.

7.4 Purchasing

7.4.1 Purchasing process

Cleanzone Technology Ltd has an established purchased process to ensure that purchased products conform to specification, please refer to SOP 12.0002 'Purchasing of Goods' .

Cleanzone Technology Ltd evaluates and selects its suppliers based on their ability to supply product in accordance with our requirements.

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Cleanzone Technology Ltd. Quality Manual
Document Ref: 7.0 Product Realization Revision: 03
Date: 18 Sept 09
Page: Page 4 of7 Suppliers shall be evaluated and selected on the basis of their ability to meet product requirements, including any specific quality requirements. Please refer to SOP 12.0002 'Purchasing of Goods'.

Suppliers will be re-evaluated using the following criteria:

• Continual approval

• Ongoing assessment of delivery, service, and quality performance and records of the re-evaluation will be recorded on form F-0018 Supplier Review form.

7.4.2 Purchasing information

The purchase order shall contain a clear description of the material ordered, including details such as type, specification, description, and quantity.

The purchase requisition will be reviewed prior to the order being placed. A record of the Purchase order will be kept for a period of ten years and will then be destroyed.

7.4.3 Verification of purchased product

Purchased products are verified upon receipt, as outlined in SOP 12.0002 'Purchasing of Goods'.

7.5 Production and service provision

7.5.1 Control of production and service provision

Production and any service provisions shall be planned and carried out under the following controlled conditions:

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Cleanzone Technology Ltd. Quality Manual
Document Ref: 7.0 Product Realization Revision: 03
Date: 18 Sept 09
Page: Page 5 of7 a) The specification or other information that describe the scope of work shall be

available

b) Standard operating procedures and method statements shall be available

c) Suitable Equipment shall be used

d) The availability and use of monitoring and measuring equipment

e) The implementation of monitoring and measurement

f) Specified release, delivery and post-delivery activities shall be implemented. An agreed date of commencement and completion shall be determined between the customer and Cleanzone Teclmology Ltd.

g) All work is documented including quality plans, procedures, where necessary.

7.5.2 Validation of processes for production and service provision

The services provided by Cleanzone Technology Ltd cannot be directly measured or validated so this clause does not apply to the company.

7.5.3 Identification and traceability

Cleanzone Technology Ltd shall identify the equipment status with respect to monitoring and measurement requirements throughout the provision of the validation and maintenance service.

Cleanzone Technology Ltd shall control the unique identification of all monitoring and measuring equipment and maintain calibration records.

Cleanzone Teclmology Ltd shall control and maintain customer files and records of all completed works which are readily identifiable and traceable in the report format.

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Cleanzone Technology Ltd. Quality Manual
Document Ref: 7.0 Product Realization Revision: 03
Date: 18 Sept 09
Page: Page 6 of7 7.5.4 Customer Property

All employees of Cleanzone Teclmology Ltd shall exercise care when customer property is under their control or use. Cleanzone Technology Ltd shall identify, verify, protect and safeguard customer property.

No customer property with the exception of customer standard operating procedures would be stored or held at the premises of Clean zone Technology Ltd.

7.5.5 Preservation of product

The conformity of the HV AC maintenance and validation service to customer requirements and applicable legal requirements is preserved during execution of work and final report delivery to the customer.

For business continuity and preservation of product all business and IT back up systems are managed by retention in a hard drive and all company documents and records are retained for 10 years in both soft and hard format on data drive.

Three sets of equipment and associated documentation necessary to perform HV AC maintenance and validation services are stored in each of the three company vans.

INFORMATION ONLY

Cleanzone Technology Ltd. Quality Manual
Document Ref: 7.0 Product Realization Revision: 03
Date: 18 Sept 09
Page: Page 7 of7 7.6 Control of monitoring and measuring devices

Measuring and monitoring devices that are used to demonstrate the conformance of a process to specified requirements are controlled according to the calibration SOP 12.0001 'Tracking of Test Equipment and Calibration Equipment'. Each device will have asset number and an associated calibration record.

Cleanzone Technology Ltd establishes processes to ensure that monitoring and measurement can be carried out, and carried out in a manner that is consistent with monitoring and measurement requirements. To ensure valid results all measurement equipment is:

a) Calibrated at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standard and calibration records maintained

b) adjusted or re-adjusted as necessary

c) Has identification to enable the calibration status to be determined

d) Is safeguarded from adjustment that would invalidate the measurement results

e) Is protected from damage and deterioration during handling, maintenance and storage.

Cleanzone Technology Ltd shall assess and record the validity of previous measuring results when equipment is found not to conform to requirements. The company will take appropriate action on the equipment and any service affected.

Records of the results of calibration and verification shall be maintained as detailed in section 4.2.4 control of records.

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Cleanzone Technology Ltd. Quality Manual
Document Ref: 8.0 Measurement, Revision: 03
analysis and improvement
Date: 18 Sept 09
Page: Page 1 of5 8. Measurement, Analysis and improvement

8.1 General

Planning for· monitoring, measurement, analysis and improvement activities occurs at two levels:

1) The service level - ensuring and demonstrating conformity of the monitoring and measuring equipment. The Directors are responsible for allocating resources for ensuring that the appropriate tools and measuring and monitoring equipment used for maintenance and validation activities are inspected to ensure that they are fit for intended use and are within calibration; and the maintenance of the calibration records. Such activities are reviewed during Management Review meetings, where customer satisfaction is analysed to determine where improvements at the service level can be made.

2) The system level - ensunng and demonstrating conformity of the quality management system to the requirements of ISO 9001:2008 and to our own . established procedures and policies as well as the achievement of objectives.

Planning at the system level includes scheduling internal audits and measuring customer satisfaction.

8.2 Monitoring and measurement

8.2.1 Customer Satisfaction

Customer Satisfaction is considered during Management Review Meetings. Customer satisfaction data is collected and reported from site feedback, customer compliments, repeat business and new business.. Senior management ensures that data regarding

INFORMATION ONLY

Cleanzone Technology Ltd. Quality Manual
Document Ref: 8.0 Measurement, Revision: 03
analysis and improvement
Date: 18 Sept 09
Page: Page 2 of5 product and process conformance, supplier performance, and customer satisfaction is collected, recorded and analysed.

Although measurements of such performance indicators may be collected, as becomes available, such data is analysed during Management Review Meetings. Customer satisfaction data is a vital tool in driving improvement of the quality management system.

8.2.2 Internal Audits

Cleanzone Technology Ltd conducts periodic internal audits to determine whether or not the quality management system conforms to the requirements of ISO 9001 :2008, our standard operating procedures and whether or not the system has been effectively implemented and maintained.

Such audits are in accordance with the Internal Audit procedure SOP 11.0005. This procedure defines the requirements for nominated personnel to perform audits and for recording the results and reporting them to management. The Management Representative is responsible for scheduling and managing regular internal quality audits.

Every area of the company that affects product quality will be scheduled for internal audits, according to the status and importance of the activities being audited taking into consideration the results from previous audits.

Audits are performed by nominated personnel who are independent of the area being audited. Findings are recorded on non conformance forms F-0008, which are submitted to Management who ensure that corrective actions are implemented in a timely manner. Audit findings and results are reviewed at Management Review meetings.

INFORMATION ONLY

Cleanzone Technology Ltd. Quality Manual
Document Ref: 8.0 Measurement, Revision: 03
analysis and improvement
Date: 18 Sept 09
Page: Page 3 of5 8.2.3 Monitoring and Measurement of Processes

Cleanzone Technology Ltd applies suitable methods for monitoring and measuring the quality management processes necessary to meet customer requirements and applicable standards. These methods confirm the continuing ability of each service provided by Cleanzone Technology Ltd to achieve the planned results. When planned results are not achieved, corrective actions are discussed with the customer and appropriate action agreed.

8.2.4 Monitoring and Measurement of the Product

The provision of the HV AC maintenance or validation service will be monitored to ensure and verify customer requirements are met. The monitoring activities are carried out at the appropriate stages of the work in accordance with planned arrangements. Any rework/retests are clearly identified.

Once the work is completed, a report is generated as outlined in SOP on Report Generation 11.0002. The Directors are responsible for the final approval of the report and release of the report for issuance to the customer.

8.3 Control of nonconforming product

Cleanzone Technology Ltd shall ensure that any product which does not conform to requirements is identified and controlled to prevent its unintended use and delivery, please refer to SOP on Non conforming product 12.0004.

Cleanzone Technology Ltd shall deal with any non conforming product by

lNFORMATION ONLY

Cleanzone Technology Ltd. Quality Manual
Document Ref: 8.0 Measurement, Revision: 03
analysis and improvement
Date: 18 Sept 09
Page: Page 4 of5 taking action to eliminate the detected nonconformity as outlined in SOP 12.0004 Non Conforming Product.

Goods received from suppliers and found to be nonconforming are also segregated into designated areas. Items that do not conform to specification are returned to the supplier as outlined in SOP on Purchasing of Goods 12.0002.

Non conforming equipment is clearly identified as not working and stored in a dedicated kanban area until it is sent for repair or removed from service. Nonconfonnities are recorded and analysed to determine trends, consider improvements and provide input to Management reviews.

8.4 Analysis of Data

Cleanzone Technology Ltd collects and analyses data from the quality objectives to determine the suitability and effectiveness of the quality management system and to evaluate where continual improvement can be made e.g. in report generation and turnaround. This shall include data generated as a result of monitoring and measurement and other relevant sources.

The analysis of data shall provide information relating to:

a) Customer satisfaction, collated during annual contract review and site feedback

b) Conforming to business continuity and IT systems infrastructure as per section 8.2.4

c) Characteristics and trends of processes and products including opportunities for preventive actions

d) Suppliers as outlined in the SOP on Purchasing of Goods 12.0002.

'NFORMATION ONLY

Cleanzone Technology Ltd. Quality Manual
Document Ref: 8.0 Measurement, Revision: 03
analysis and improvement
Date: 18 Sept 09
Page: Page 5 of5 8.5 Improvement

8.5.1 Continued Improvement

Cleanzone Technology Ltd continually seeks to improve the effectiveness of quality management system through the use of the quality policy, quality objectives, audit reports, data analysis, customer feedback, corrective and preventative actions and management reviews.

8.6 Corrective Actions

Cleanzone Technology Ltd takes immediate actions to eliminate the cause of nonconformances in order to prevent recurrence. The corrective actions process includes identifying nonconformities, establishing a resolution time, evaluating the need for action to avoid recurrence, implementing the corrective action, recording the results of corrective actions and reviewing the effectiveness of corrective actions taken. Please refer to SOP 11.0004 on Corrective and Preventative Action.

Cleanzone Technology Ltd determines preventative actions to eliminate the cause of potential nonconformities in order to prevent their occurrence. Preventative actions are appropriate to the effects of the potential problems. Please refer to SOP 11.0004 on Corrective and Preventative Action.

8.7 Preventive Action

INFORMATION ONLY

Appendix 1 - Quality Policy

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I I

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......

INFORMATION ONLY

Cleanzone Technology Ltd.

INTEGRATED QUALITY l\'lANAGEMENT SYSTEM POLICY:

Cleanzone Technology's ~ssion statement is - To be the best, versatile, high tech, technically competent company with an emphasis on customer service and satisfaction through Quality, Right First Time and

~ei~g a Team Player. Cleanzone Technology Ltd was formed in November 2001with'a goal to be The Best. Our aim to be The Best

,;

will be reflected in the standard of our work and in the safe and efficient way we carry out this work. Cleanzone Technology Ltd will embrace all the principles of current Good Manufacturing Practices (cGMP).

Cleanzone Technology Ltd is committed to managing quality, environmental health and safety matters as an Integral part of our business. In particular it is out policy to ensure the integrity of processes and facilities at

all times and at all places. We will do this by adhering to the following principles. <Q

We will comply with all applicable legal requirements and will implement programs and procedures to assure compliance. Strict compliance with standards will be a key ingredient in the training, performance review and incentives of all employees. Our clients Quality System, the Food and Drug Administration (FDA), and the Irish Medicines Board (IMB), will guide us.

We will employ management systems and procedures specifically designed to prevent activities/conditions that pose a threat to human health, safety and the environmerit. We will recycle where we can.

We will communicate our commitment to quality toour employees, customers and suppliers. We will solicit their input ill meeting our objectives and targets and will in turn offer assistance to ensure customer goals and requirements are continually adhered to and enhanced.

We will continuously seek opportunities to improve our adherence procedures and principles and will report our progress to all parties.

tiL_;,~·

Johnny Curran

Chairman and M?naging Director

Date

~' ..

COMPANY STAMP

2'_-~,_J ~26o~ Date

INFORMATION ONLY

Appendix 2 - Organisation Flow Charts

INFORMATION ONLY

Organisation Chart

INFORMATION ONLY

CLEANZONETECHNOLOGY LTD (C.T.L)

Johnny Curran Chairman & Group Operations Director

I

J

GerDuhig Managing Director & Quality Management Representative

I

C.T.L. VALIDATION VALIDATION TEAM LEAD VALIDATION TEAM MEMBERS

C.T.L.lVlAINTENANCE NUUNTENANCETEAMLEAD lVlAINTENANCE TEAM MEMBERS

Validation Execution commissioning! monitoring and witnessing

Contract Maintenance Permanent Allocation or Call Out Maintenance Site Engineers

Health and Safety Cleanroom validation Filter Integrity Tests Particle Counts Monitoring

Help Desk

Mobile Support

Call Out Validation

Health and Safety Delivery of Maintenance Mobile Support HeIp Desk

Contract Maintenance Permanent Allocation Call out Maintenance Site Supervision

INFORMATION ONLY

Appendix 3 - List of SOP's - Current at time of Quality Manual Rev Sign Off

Cleanzone

Techn%jJ90llMATION ONLY

Kilrush Business Park, Dungarvan, Co. Waterford.

Phone: 058 44065 Fax: 058 44069 E-Mail: info@cleanzone.ie

SECTION 1

OPERATION STANDARD OPERATING PROCEDURES

TITLE

NUMBER

METHOD OF USING A SHORTRIDGE FLOWHOOD AND MULTIMETER

9.0001

AEROSOL PHOTOMETER

9.0002

METHOD OF USING A DOP SOLUTIONS AEROSOL GENERATOR

9.0003

METHOD OF USING A CLIMET PARTICLE COUNTER

9.0004

METHOD OF USING A TEMPERATURE AND HUMIDITY PROBE, LUX METER AND A SOUND LEVEL METER

9.0005

METHOD OF USING A VANE ANEMOMETER

9.0006

METHOD OF USING A FACTAIR F3000 SAFE-AIR TESTER

9.0007

METHOD OF USING A HIGH PRESSURE REGULATOR F3002

9.0008

INFORMATION ONLY

Cleanzone .' "",\ "! -:;~ '"IN ONLY

.•. ~iU H 'v

Technology Ltd.

Kilrush Business Park, Dungarvan, Co. Waterford.

Phone: 058 44065 Fax: 058 44069 E-Mail: info@cleanzone.ie

SECTION 2

VALIDATION STANDARD OPERATING PROCEDURES

TITLE

GRILLE VOLUME READINGS ON A SUPPLY HEPA FILTER DEVICE

PROCEDURE FOR CALCULATING ROOM AIR CHANGE RATES

HEPA FILTER INTEGRITY (LEAK) TEST

CLASSIFICATION OF AIRBORNE . CLEANLINESS PARTICLE COUNTING.

MEASUREMENT OF LIGHT INTENSITY, SOUND LEVELS, TEMPERATURE AND HUMIDITY LEVELS

ROOM DIFFERENTIAL AIR PRESSURE

ENCLOSURE (INDUCTION) INTEGRITY TEST ON CONSTRUCTION JOINTS, SEAMS AND DOORS

VALIDATION & TESTING OF LAMINAR FLOW BOOTHS

VALIDATION & TESTING OF CLASS III SAFETY CABINETS, GLOVE BOXES & ISOLATORS

VELOCITY READINGS IN A LAF UNIT/HEPA FILTER DEVI,CE

OBTAINING BRANCH DUCT VOLUME READINGS

FLOOR CONDUCTIVITY TESTING FOR CLEANROOMS

CLEANROOM RECOVERY TEST

AIRFLOW VISUALISATION FOR CLEANROOMS

MONITORING AND TESTING OF COMPRESSED BREATHING AIR, COMPRESSED AIR AND NITROGEN

NUMBER

10.0001

10.0002

10.0003

10.0004

10.0005

10.0006

10.0007

10.0008

10.0009

10.0010

10.0011

10.0012

10.0013

10.0014

1 f\ f\fl1::;

Cleanzone . t.nRMATION ONLY

Technology ifWoo'

Kilrush Business Park, Dungarvan, Co. Waterford.

Phone: 058 44065 Fax: 058 44069 E-Mail: info@cleanzone.ie

SECTION3

QUALITY STANDARD OPERATING PROCEDURES

SOP ON sOP'S

11.0001

TITLE

NUMBER

SOP ON REPORT GENERATION

11.0002

CUSTOMER FEEDBACK SOP

11.0003

CORRECTIVE AND PREVENTATIVE ACTION SOP

11.0004

INTERNAL AUDITING SOP

11.0005

NON CONFORMANCE SOP

11,0006

Cleanzone INFORMATION ONLY Technology Ltd.

Kilrush Business Park, Dungarvan, Co. Waterford.

Phone: 058 44065 Fax: 058 44069 E~Mail: info@cleanzone.ie

SECTION 4

GENERAL STANDARD OPERATING PROCEDURES

TITLE

NUMBER

TRACKING TEST EQUIPMENT CALmRATION SOP

12.0001

PURCHASING OF GOODS SOP

12.0002

TRAINING SOP

12.0003

NON CONFORMING PRODUCT SOP

12.0004

MANAGEMENT OF OUTSOURCED PERSONNEL SOP

12.0006

INFORMATION ONLY

Appendix 4 - List of Validation and Maintenance Check Sheets

INFORMATION ONLV

Validation Check Sheets Index

Reference No:

Description

CNCS 1 CNCS2 CNCS3 CNCS4 CNCS5 CNCS6 CNCS7 CNCS8 CNCS9 CNCS 10 CNCS 11 CNCS 12 CNCS 13 CNCS 14 CNCS 15 CNCS 16 CNCS 17 CNCS 18 CNCS 1.9 CNCS 20 CNCS 21 CNCS 22 CNCS 23 CNCS 24 CNCS 25 CNCS 26 CNCS 27· CNCS 28 CNCS 29 CNCS 30 CNCS 31 CNCS32 CNCS 33 CNCS 34 CNCS 35 CNCS 36 CNCS 37 CNCS 38 CNCS 39

Air Distribution System Initial Start Report

Air Distribution System Pre Commissioning Report Air Handling Unit Supply Fan Performance Report Air Handling Unit Return Fan Performance Report Air Handling Unit Extract Fan Performance Report Branch Volume test Sheet .

Main Branch Volunie Checklist

Grille Test Sheet

Diffuser Test Sheet

V.A.V Test Sheet

Branch Volume Test Sheet Summary Sheet HEPA Filter Integrity Test Sheet

Particle Counts

Filter Velocity/volume results

HEPA Filter VelocityNolume Results Lighting Profile

Air Differential Pressure test

Grille Volume Test Sheet Temperature/Relative Humidity Profile Equipment Used

Air Changes Per Hour Noise Level Under GrilleS

Laf Diffuser VelocityNolume Test Sheet

Fume Hood VelocityNolume Test Sheet Downflow Booth VelocityNolume Test Sheet Extract Hood VelocityNolume Test Sheet Sterilisation Tunnel VelocityNolume Test Sheet Glove Breach TesWelocity Test Sheet Gauntlet Breach TesWelocity Test Sheet

Not In Use

Not In Use

Vacuum Cleaner Hepa Integrity Test Sheet Compressed Air Test Sheet

Sound Level Readings

Compressed Breathing Air Test Sheet Nitrogen Gas Test Sheet

Hepa Velocity Results (Velgrid)

Differential Particle Counts for compressed gasses Accumulative Particle Counts for compressed gasses

INFORMATION ONLY

Maintenance Check Sheets Index

Reference No:

Description

M1 M2 M3 M4 M5 M6 M7 M8 M9 M10 M11 M12 M13 M14 M15 M16 M17 M18 M19 M20 M21 M22 M23 M24 M25 M26 M27 M28 M29 M30 M31 M32 M33 M34 M35 M36 M37

Air Handling Unit Supply Fan Checklist Return Fan Checklist

Extract Fan Checklist

Fume Cupboard Checklist

Split DX Refridgerant Unit Checklist Cooling Tower Checklist

Pumps Checklist

Pressurisation Unit Checklist Evaporative Humidifier Checklist Electric Humidifier Checklist

Steam Humidifier Checklist Dehumidifier Checklist

Dust Extractor Checklist

Air Compressor Checklist Boiler/Burner Checklist

Oil Tanks & Transfer Pumps Checklist Calorifier Checklist

Unit Heater Checklist

Electrical Transformers Checklist Sliding Doors Checklist Automatic Shutter Door Checklist Controls Checklist

Buffer Tanks Checklist

Main Branch Volume Checklist Automatic Sliding Doors Checklist Downflow Booth Checklist

Fresh Air Intake Checklist Scrubber Blower Checklist

Executive Summary Comment Sheet Executive Summary Action Sheet

Executive Summary Action & cost Approval Sheet Laminar Flow Booths Checklist

Dust Collector with Extract Fan Checklist LAF Checklist

Fan Coil Unit Checklist Close Control Unit

Air Handling Unit Supply Fan with Humidifier Checklist

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