Safety, Quality and Process Assurance
Quality Assurance Manual
Quality is the cornerstone of our Company´s values: Continuous Improvement, Innovations and Creativity, Integrity, Teamwork and Passion.
2. Policy & Objectives
4. Quality Management System (QMS)
6. Authority & Responsibilities
7. Compliance to ISO9001
8. Management Review & Internal Audit
9. Contract Review
10. Advance Quality, Safety and Process Planning
11. Documentation & Change Control
13. Customer Supplied Items
14. Process Control
15. Receiving Inspection
16. Inspection & Testing
17. Production & Measuring Equipment
18. Indication of Inspection Status
19. Non-conforming Items, Preventive & Corrective Action
20. Handling, Storage, Packaging, Preservation & Shipping
CYMER, LLC was formed in 1997 to satisfy customer requirements for the manufacture of custom chemical products. This business has developed well and is expanding successfully.
Additional capabilities have been added to the organization to include contract manufacturing, toll manufacturing, process development, scale-up & pilot programs, and blending and formulation.
This Quality System relates to the full range of company activities.
Quality is the cornerstone of our Company's values: Continuous Improvement, Innovations and Creativity, Integrity, Teamwork and Passion.
The CYMER, LLC quality policy is to achieve sustained, profitable growth by providing services that consistently satisfy or exceed the needs and expectations of its customers.
This level of quality is achieved through adoption of a system of procedures that reflect the competence of CYMER, LLC to existing customers, potential customers, and auditing authorities or agencies.
Achievement of this policy involves all the Cymer staff, which are individually responsible for the quality of their work, resulting in a continually improving processes and working environment for all. This policy is provided and explained to each employee by the President and General Manager.
To achieve and maintain the required level of assurance the President and General Manager retains responsibility for the Quality Management System with routine operation controlled by the Environmental, Safety and Health Manager.
The objectives of the Quality Assurance System are:
a) To maintain an effective Quality Assurance System complying with International Standard ISO9001 (Quality Systems).
b) To achieve and maintain a level of quality which enhances the Company's reputation with customers.
c) To ensure compliance with relevant statutory and safety requirements.
d) To endeavor, at all times, to maximize customer satisfaction with the services provided by CYMER, LLC.
Frank LaMonica Owner, President and General Manager.
The terms and descriptions used in this Manual are generally defined within ISO9001 - Quality Systems.
The Quality Assurance System applies to all activities of CYMER, LLC, and has been developed in accordance with ISO9001. The Quality Assurance System is fully documented and structured in 3 levels:
Level 1: Quality Manual
This document details the corporate quality policy and structure of CYMER, LLC and references appropriate Operating Procedures.
Level 2: Operating Procedures
These documents describe the actual process, and controls applied, to all activities concerned with the attainment of a quality assured product.
A list of Operating Procedures is given in the Index Section of this Quality Assurance Manual.
Level 3: Quality Planning
CYMER, LLC is a custom chemical manufacturing service company, customer satisfaction and quality are achieved by operation in accordance with the documented quality system. Specific customer requirements are identified and documented during the contract review process, allowing these requirements to be communicated and achieved, ensuring satisfaction of all customers declared needs.
See Attachment A � Organizational Chart
6.1.1 All staff are allocated with authority to perform their allocated responsibilities. The following provides a summary of the principal responsibilities of each job role, and these are clarified in greater detail within the Operating Procedures.
6.1.2 All staff share the authority and responsibility of identifying non-compliances or possible improvements, and recording these instances such that corrective action can be taken, both to rectify the immediate situation and to prevent recurrence.
6.1.3 The Managing Director continually reviews the company's resources to ensure that adequate staff, equipment and materials are available to meet customer requirements.
All Cymer employees support the Quality Management System by
6.2.1 President and General Manager
6.2.3 Administrative Assist Accounting
6.2.4 Administrative Assist Customer Service
6.2.7 Process Engineer
6.2.8 Safety Engineer
6.2.9 Shift Supervisor
6.2.11 Maintenance Leadsman
6.2.12 Maintenance Technician
6.2.13 Day Operator
6.2.13 Lab Technician
This Quality Management System is structured with policy statements relating to each area of activity being within the relevant Operating Procedure.
Management review of the suitability and effectiveness of the Quality System take place at least twice per year. During the management meetings actions are allocated and monitored to record the development of the Quality Management System.
The objectives of Management Review are:
a) To establish that the Quality Management System is achieving the expected results and meeting the Company's requirements, continuing to conform to the Standard, continuing to satisfy the customers´ needs and expectations, and functioning in accordance with the established Operating Procedures.
b) To expose irregularities or defects in the System, identify weaknesses and evaluate possible improvements.
c) To review the effectiveness of previous corrective actions, and to review the adequacy and suitability of the management system for current and future operations of the Company.
d) To review any complaints received, identify the cause and recommend corrective action if required.
e) To review the finding of internal/ external audits and identify any areas of recurring problems or potential improvements.
f) To review the reports of nonconforming items and trend information to identify possible improvements.
Internal audits of the Quality System are undertaken at least once per year to confirm that the function concerned is adhering to Procedures. A comprehensive Audit Program is compiled at least once a year; however, should particular needs be identified, the frequency of audit may be increased at the discretion of the ESH Manager.
Auditors who are trained in auditing and not directly responsible for the functions being audited undertake audits. Nonconformance observed is brought to the attention of the person responsible, and is recorded, documented and subject to timely corrective action to ensure full rectification.
CYMER, LLC offers custom chemical manufacturing services. Cymer services are tailored to meet each customer's needs. Specialty services include contract manufacturing, toll manufacturing, process development, scale-up & pilot programs, and blending and formulation.
Customer inquiries and contact information is confidential. CYMER, LLC demonstrated integrity in the protection of customer information is well known in the chemical industry. All information is considered private and confidential and is only released by specific customer request.
Confidentiality, integrity and availability of data regardless of the form the data may take: electronic, print, or other forms is guarded by CYMER, LLC
Specialist service requirements differ from one customer to another (and from one contract to another), therefore each tends to be quoted for the specific contract.
Once a proposal is accepted by the customer, or an order is placed, it is recorded and reviewed to establish that the requirements of the order are adequately defined and documented, any differences from the proposal are resolved, and CYMER, LLC is capable of fully satisfying the customers´ requirements.
In addition to the original order/ contract specification the customer may also request addition/ variation work to be undertaken by Cymer. In these circumstances the work content is documented and agreed with the customer prior to execution to ensure that no ambiguity exists.
10. ADVANCE QUALITY, SAFETY AND PROCESS PLANNING
All Design/Process activities are strictly controlled to ensure that the output information complies with customer/ contract requirements, and all input data.
Design/Process activities are planned and normally executed by specialists and are subject to regular management, review and verification by the President and General Manager, and where relevant, agreement with the Customer.
The design/process input and output items are documented, and where ambiguity exists, will be clarified and documented. All items of design/process documentation and notes are recorded in a risk assessment folder. Design output documentation is produced and reviewed to ensure that it:
Design/Process output is reviewed and approved by the President and General Manager, and is also provided to the Customer for approval prior to manufacture or operation. Validation of the design/process is achieved during commissioning of the system to confirm compliance to the customer's requirements and safety.
The design/process is required to specify any inspections or tests which may verify the design/intermediates, by practical means, at the earliest possible stage of development or production.
All changes to the design/process criteria, input or output are subject to strict review and documentation control procedures.
All documentation utilized within Cymer related to the QMS itself, or to the execution of individual customer contracts is controlled to ensure that it is issued to the appropriate personnel, under the correct level of authority, is revised and reissued as necessary, and all obsolete versions are removed from the point of use.
Such documentation typically includes:
The Quality Assurance Manual, Procedures and Quality Plans are maintained by the ESH and Quality Manager who ensures that the appropriate items, at the correct revision levels, are issued to all who need them within the Company.
National/ International Standards, Codes of Practice are maintained by the Technical Engineers who ensure that appropriate documents are available within the Company, and are issued at the correct revision levels. External suppliers of documentation are contacted regularly to ascertain that the documents held remain current.
The distribution of standard documents is controlled and recorded on Distribution Lists, which also show the current issue status. The Distribution Lists are reviewed and updated as changes occur.
All changes to documents are reviewed and approved by the person responsible for the original issue and, where appropriate, the nature of the change is indicated on the document. Master copies of the revised documents are retained as records of the changes and renewed as necessary to ensure clarity.
Each contract has a File that contains all relevant information.
Suppliers of products, materials and services, where unspecified by a customer contract, are selected on their ability to meet the company's requirements given due consideration to the quality, statutory obligations, timescale and cost. A list of approved suppliers and sub-contractors is maintained which is compiled on the following criteria:
a) Previous performance in supplying to similar specifications and requirements.
b) Stocking of high volume standard items conforming to a relevant standard, or supplied with a statement of conformity.
c) Compliance with an approved third party product/ quality registration scheme.
d) Recommendation by other similar purchasers or manufacturers of equipment.
e) A trial order and evaluation of performance.
All supplies and sub-contracts are subject to an authorized Purchase Order providing full clarification of the type and extent of supply.
Should a supplier, not appearing on the Approved Suppliers List be proposed, they will be analyzed by capability and subject to acceptance on the authority of the President and General Manager.
Goods received from customers (i.e. free issue items or equipment) are always visually inspected at the receipt stage, with any un-declared non-conformance being immediately reported to the customer.
Customer materials and equipment are acknowledged to customer upon receipt and monitored per contract/agreement.
All productive work is planned and undertaken in accordance with the company's procedures, and any specific documents agreed for individual contracts (e.g. contract specifications).
Work instructions are provided by the agreed contract specification and any documents referenced therein, alternatively work is performed in accordance with nationally accepted codes of practice.
All storage areas are maintained as secure as practical. All items received by Cymer are identified and verified in accordance with the requirements of the Delivery Note and Purchase Order, and are inspected for correct identity, quantity and any signs of damage.
All goods received are documented and, in the event of non-conformance, the items are placed in a reject area or labeled to ensure identification. The extent of the non-conformance is noted and subject to disposition review by nominated personnel.
Inspections and testing is carried out on completion Batch/Lot Record, with results being documented. Should items not be acceptable against the agreed contract criteria, they will be identified for a subsequent evaluation and decision. All reworked items are subject to a re-inspection to ensure acceptability.
During the processes of manufacture, process development, scale-up & pilot programs, and blending and formulation, the customer is also invited to check the work performed to ensure full acceptability thru document review, analytical test and evaluation.
On completion of manufacture, process development, scale-up & pilot programs, and blending and formulation, the customer is also invited to check the work performed to ensure full acceptability thru document review, analytical test and evaluation.
Production and measuring equipment held is maintained in good condition, and capable of safe and effective operation within a specified tolerance of accuracy. Test and measuring equipment is regularly inspected or calibrated to ensure that it is capable of accurate operation, by comparison with external sources traceable back to Industrial Standards.
Electrostatic protection equipment is utilized when handling sensitive compounds, and is regularly checked to ensure that it remains fully functional.
As indeterminate and finished products are inspected, Batch/Lot Record defines the status, with all non-conforming items being placed in a reject area or marked as reject for review. The status of work in progress is established by markings or associated documentation recording the inspections undertaken and their acceptability as reflected in the Batch/Lot Record.
Once non-conforming items have been noticed they are identified by location, associated documents, or specific markings to prevent their inadvertent use. All non-conforming items and customer complaints are subject to review and rectification by nominated personnel. The type and extent of non-conformity is documented in order to establish trends and identify possible areas for improvement.
The corrective action required to prevent recurrence is evaluated, documented, and its effective implementation is monitored. All rectification is subsequently re-inspected to ensure complete customer satisfaction.
All employees are encouraged to suggest improvements in methods, materials, suppliers, and sub-contractors. Cymer has established procedures for review of all activities in order to identify and evaluate all possible improvements in methods/ materials and its procedures.
The identification of materials, where it is not obvious, is confirmed by the presence of a manufacturers/ suppliers part number or description label, or other marking for each item. The identification of the item may be on the packaging or on the item itself, and this identification remains in place for as long as possible, provided it does not hamper effective use of the item. Materials and consumables are not identified by the company where they are obvious to a trained/ experienced employee, however, should a risk of misinterpretation exist between two or more types of material these will be marked in a suitable manner to ensure that no ambiguity exists.
All items with serial/lot numbers are recorded individually.
Materials and goods received, whether the property of the company or others, will, as far as practicable, be protected and their quality preserved until such time as they are transferred to a customer, or disposed of to a third party. The objective is to prevent deterioration and damage while in storage, or in the process of transportation, or commissioning.
Storage facilities are allocated which ensure that all stored records are identifiable and retrievable, and the storage areas are free from damp and other agents, which could cause premature deterioration.
Where records are maintained on computer magnetic media, and these are subject to "back-up" at regular intervals, with the "back-up" information being stored in a protected location to ensure security from loss/ damage of active data.
All records are retained for a minimum of 2 years.
The policy of the company is to ensure that all personnel are trained and experienced to the extent necessary to undertake their assigned activities and responsibilities effectively. The company generally procures and recruits employees capable of meeting the technical, skill, experience and educational requirements of the company's activities.
All staff and senior employees are responsible for recommending the training needs of others, and for ensuring that all employees allocated specific tasks are suitably qualified and experienced to execute those tasks. Once training needs are identified these are provided under the responsibility of the President and General Manager.
Full records are maintained of all training undertaken by employees.
Custom Chemical Manufacturing
124 Cymer Lane
Decatur, TN 37322
Business Development Manager Joan Roller
Cymer Custom Chemical ManufacturingTM©2012