QUALITY SYSTEMS MANAGEMENT

WHAT ARE THE POINTS YOU WILL KEEP IN MIND ABOUT THE CONCEPT OF QUALITY CONTROL AND INSPECTION IF YOU ARE THE QUALITY SYSTEMS MANAGER OF A RUBBER PRODUCTS MANUFACTURING UNIT ?

AS A QUALITY SYSTEMS MANAGER OF A RUBBER PRODUCTS MANUFACTURING UNIT , THE CONCEPT OF QUALITY CONTROL AND INSPECTION CAN BE ONLY BE IMPLEMENTED BY STRICTLY FOLLOWING THE BELOW MENTIONED POINTS:

INTRODUCTION

Quality Control :

Quality Control can be defined as the entire collection of activities which ensure that the operation will provide the optimum quality products at minimum cost .

In other words, it is a systematic control of various factors that affect the quality of the product. It depends on material, tools, machines, types of labour, working conditions, measuring instruments etc.

Inspection :

Inspection means checking of material, product or components of product at various stages , with reference to certain pre-determined factors and detecting and sorting out the faulty or defective items.

Inspection is one of the part of Quality Control process.

Quality Control Objectives

As a quality system manager my objectives for quality control would be:

1) strive to be the supplier of choice for my companies customers.

2) establish zero defects as the goal of production.

3)meet customer expectations for on-time delivery.

4)avoid waste and excessive cost without jeopardizing quality.

5)provide a safe environment for employees.

For Quality Control, I will have to

• identify the processes needed for the quality management system and their application throughout the organization

• determine the sequence and interaction of these processes

• determine criteria and methods needed to ensure that both the operation and control of these processes are effective

• ensure the availability of resources and information necessary to support the operation and monitoring of these processes

• monitor, measure and analyze these processes and

• implement actions necessary to achieve planned results and continual improvement of these processes

• document statements of the quality policy and quality objectives

• my companies quality manual

• document procedures required by ISO 9001:2000 or ISO/TS 16949:2002

• documents needed by my company to ensure the effective planning, operation and control of its processes

• keep records required by ISO 9001:2000 or ISO/TS 16949:2002

For quality control, I will have to establish and maintain a quality manual that includes:

• the scope of the quality management system

• the documented procedures established for the quality management system, and

• the description of the interaction between the processes of the quality management system.

For quality control , a documented procedure will have to be established to define the controls needed:

• to approve documents for adequacy prior to issue

• to review and update as necessary and re-approve documents

• to ensure that changes and the current revision status of documents are identified

• to ensure that relevant versions of applicable documents are available at points of use

• to ensure that documents remain legible and readily identifiable

• to ensure that documents of external origin are identified and their distribution controlled, and

• to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose

Quality Policy

For quality control, I will have to ensure that the quality policy

• is appropriate to the purpose of the organization

• includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system

• provides a framework for establishing and reviewing quality objectives and

• is reviewed for continuing suitability

Control of Monitoring and Measuring Devices

For Quality control and Inspection :

I will have to determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements.

I will have to establish processes to ensure that monitoring and measurement can be carried out in a manner that is consistent with the requirements.

When necessary to ensure valid results, measuring equipment will have to :

• be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification will be recorded

• be adjusted or re-adjusted as necessary

• be identified to enable the calibration status to be determined

• be safeguarded from adjustments that would invalidate the results

• be protected from damage and deterioration during handling, maintenance and storage If equipment is found to be out of calibration, I will have to assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. Appropriate action will be taken on the equipment and any product affected. Records of the results of calibration and verification will be maintained. When used in monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application is confirmed. This action is undertaken prior to initial use and reconfirmed as necessary.

Inspection / Monitoring and Measurement

For Quality Control and Inspection, one needs to monitor information relating to customer perception as to whether the customer requirements have been met.

Customer satisfaction needs to be monitored through continual evaluation of performance of the realization processes. Performance indicators will have to be based on objective data and include, but not limited to:

• delivered part quality performance

• customer disruptions including field returns

• delivery schedule performance (including incidents of premium freight), and

• customer notifications related to quality or delivery issues.

• customer surveys

One has to monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for produce quality and efficiency of the process.

One has to conduct internal audits at planned intervals to determine whether the quality management system:

• conforms to the planned arrangements to the requirements of ISO 9001:2000 and to the quality management system requirements established by us, and

• is effectively implemented and maintained

The internal audit program will be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods is defined.

Selection of auditors and conduct of audits ensures objectivity and impartiality of the audit process. Auditors do not audit their own work.

The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records is defined in a documented procedure.

The management responsible for the area being audited ensures that actions are taken without undue delay to eliminate detected nonconformities and their causes.

Follow-up activities include the verification of the actions taken and the reporting of verification results.

Each manufacturing process would be audited to determine its effectiveness. Products at appropriate stages of production and delivery would be audited to verify conformity to all specified requirements, such as product dimensions, functionality, packaging

and labeling, at a defined frequency. Internal audits cover all quality management related processes, activities and shifts, and are scheduled to an annual plan. When internal/external nonconformities or customer complaints occur, the audit wiil be increased.

Our internal auditors will qualify to audit the requirements of ISO/TS 16949:2002. We would apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, corrective and preventive action is taken, as appropriate, to ensure conformity of the product. We would perform process studies on all new manufacturing processes to verify process capability and to provide additional input for process control. The results of the process studies would be documented with specifications, where applicable, for means of production, measurement and test, and maintenance instructions. These documents include objectives for manufacturing process capability, reliability, maintainability and availability, as well as acceptance criteria.

We need to maintain manufacturing process capability or performance as specified by the customer approval process requirements. Control plans and process flow diagrams needs to be implemented, including adherence to the specified:

• measurement techniques

• sampling plans

• acceptance criteria, and

• reaction plans when acceptance criteria are not met

Significant process events, such as tool change or machine repair will be recorded. Reaction plans will be initiated from the control plan for characteristics that are either not statistically capable or are unstable. The reaction plans include containment of product and 100% inspection as appropriate. A corrective action plan will be completed indicating specific timing and assigned responsibilities to assure that the process become stable and capable. The plans will be reviewed and approved by the customer when required. Records needs to be maintained of effective dates of process changes. We need to monitor and measure the characteristics of the product to verify that product requirements have been met. This is carried out at appropriate stages of the product realization process in accordance with the planned arrangements.

Evidence of conformity with the acceptance criteria is maintained. Records indicate the person(s) authorizing release of the product. Product release will not proceed until all the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable by the customer.

A layout inspection and a functional verification to applicable customer engineering material and performance standards is performed for each product as specified in the control plans.

Results will be available for customer review.

For organizations manufacturing parts designated by the customer as “appearance items”, the organization will provide:

• appropriate resources including lighting for evaluation

• masters for color, grain, gloss, metallic brilliance, texture, distinctness of image, as appropriate

• maintenance and control of appearance masters and evaluation equipment, and

• verification that personnel making appearance evaluations are competent and qualified to do so.

We have to maintain documented procedures for inspection and testing activities in order to verify that the specified requirements, including key characteristics, for the product have been met.

The required inspection and testing and the accompanying records are detailed in the quality plan or documented procedures.

These procedures specify the inspection/test methods to be used, including:

• Methods of recording inspection/test results;

• Identification of authorized personnel;

• Limits of authorization;

• Training and qualification requirements.

As required, the customer, prior to use, approves acceptance sampling plans and procedures.

When 100% inspection is conducted, all of the characteristics with design requirements are inspected on every part.

In-process inspection and testing

We need to

• Inspects and tests product-in-process in accordance with the product’s quality plan and/or documented procedures and

• Holds product until the required inspection and tests have been completed or necessary reports have been received and verified, except when product is released under positive recall procedures.

All in-process inspections and tests are made at appropriate times in the manufacturing process and are performed to verify compliance with engineering requirements.

Final inspection and testing

The primary purpose of final inspection and test is to ensure that all specified receiving and inprocess tests and inspections have been performed and that the results meet the specified requirements.

As a minimum, the following NEEDS be implemented as part of the final inspection system:

• A check to ensure that all first article inspection requirements are current;

• A review of manufacturing plans to ensure that all quality requirements have been accurately implemented;

• A check to ensure that all changes have been incorporated for the units being shipped (i.e., change order, change incorporation request, corrective action implementation, trouble report, etc.);

• A final review of recorded nonconformances to ensure that they are all corrected, and / or have customer approval to ship (i.e., advanced rejection tag, open reject notice);

• A review of the customer purchase order, including applicable specifications, special instructions, etc., to ensure that all contractual requirements are complete and accurately implemented;

• A visual inspection or test of the product.

We NEED to carry out all final inspection and testing in accordance with the quality plan and/or documented procedures to complete the evidence of conformance of the finished product to the specified requirements.

No product will be shipped until all activities specified in the quality plan and/or procedures have been satisfactorily completed and the associated data and documentation are available and authorized.

Use of customer’s digital datasets as authority for design and/or inspection

Use of a customer’s digital data or dataset as authority for design and/or inspection will comply with that customer’s standards or contractual requirements. Digital datasets are used for reference only (no design or inspection authority) unless otherwise approved, authorized or compliant with customer requirements for dataset usage.

Analysis of Data

We need to collect and analyze performance measures within the Quality and Sales Departments to track the continual improvement (CI) of the quality system and to assist in determining what continual improvement projects should be initiated.

The Quality and Sales Departments gather information for these measures from inspection reports and customer data to give an indication of:

• Customer satisfaction;

• Conformity to product requirements;

• Process and product trends that can prompt preventive action;

• Supplier performance.

Advanced quality system activities, including control plans and control charts, may be used as an improvement activity for CI projects. The senior management staff reviews completed projects and determines actual benefit to use as a reference for future CI projects and activities.

Continual Improvement

The senior management team needs to ensure that continual quality improvements are implemented in an effort to reduce the variation of key characteristics called out on our or customer drawings, to prevent defects, reduce waste, increase profit, and to improve product quality and delivery. Measurement goals are determined for key quality and customer service parameters at management review meetings through the review of quality policies and objectives, audit results, preventive actions and from data collected for CI projects.

Corrective and Preventive Action

We need to maintain documented procedures for implementing corrective and preventive action and makes the appropriate changes to documented procedures resulting from corrective and

preventive actions.

Corrective action

Customer complaints, single significant product or process non-conformances and minor-but repetitive product or process non-conformances (even those product non-conformances that are dispositioned use-as-is) can cause the initiation of a corrective action.

Corrective action process needs to include:

• Root cause analysis of the problem and recording the results of the analysis;

• Determining and implementing the corrective action needed to eliminate this cause;

• Recording the results of the corrective action taken, and

• Ensuring that the corrective action taken is effective.

When timely and/or effective corrective actions are not achieved, the issue is escalated to senior management staff.

Corrective action response format

Unless otherwise specified by a customer, corrective action responses will be documented on the our corrective action form needs to include:

• A restatement of the finding;

• The immediate correction;

• The root cause of the problem;

• The corrective action that addresses the root cause;

• The corrective action verification plan;

• The follow-up that was done to check for the effectiveness of the action.

Records of the corrective actions need to be maintained. Preventive action ,we need to take into consideration information from four sources for potential preventive action:

• Statistical process control data from the waterjet machining process;

• Internal audit observations;

• Customer feedback from day-to-day conversations with Sales;

• Customer feedback from monthly surveys;

• Review of incoming materials for variation

Preventive action process needs to include:

• Determining the cause of the potential problem;

• Determining and implementing the action needed;

• Recording the results of the preventive action taken;

• Ensuring that the preventive action taken is effective.

Historical data and problem-solving tools are used to analyze and eliminate potential causes of Non-conformities.

TECHNICAL REASONS FOR TESTING

1.Rubber is a unusual and complex material. When compounded in a particular way it exhibits a unique combination of physical properties.

2. It is highly deformable with possibility of complete recovery. It’s shear and Young’s modulii are far higher than the bulk modulus.

3. Even if rubber compounds are made in identical ways, the properties may not be identical, unlike the behaviour of metal.

4. Conditions and test procedures are of paramount important in rubber testing. For example, variation in testing speed in a tensile machine may result in a significant difference in modulus.

5.Test results may differ depending upon the stress history of the test Specimen.

The above points illustrate the fact that this unusual class of material requires carefully worked out testing procedure. Methods or philosophy used for other materials cannot be simply adopted for rubber if meaningful results are to be obtained.

AS A QUALITY SYSTEMS MANAGER OF A RUBBER PRODUCTS MANUFACTURING UNIT, I WILL KEEP ABOVE POINTS IN MIND ABOUT THE CONCEPT OF QUALITY CONTROL AND INSPECTION .