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QUALITY AND R&D
Quality Management System
Purpose and Scope
To ensure deployment of an effective Quality Management System in accordance with the requirements of IS/ISO/TS 16949 : 2002. The scope of application extends to all the processes / activities in the organization.
General Requirements.
A quality management system is established, documented, implemented and maintained in line with the requirements of IS/ISO/TS 16949 : 2002.
This has been achieved by identification of core and all the support processes of the quality management system through the use of process maps, flow charts along with the sequence and interaction.
Appropriate use of control plans determines the criteria and methods for effective operation and control of identified processes. Use of Documented procedures as required by this standard, standard operating procedures and work instructions where relevant ensures availability of information to support the operation and monitoring of these processes.
Monitoring, measurement and analysis of processes is ensured through Stage and final inspection, internal audits, performance measurements and statistical process control techniques (like APQP and FMEA) deployment.
Periodic internal audits, application of appropriate corrective and preventive actions and consolidation of all this data through management reviews enable continual improvement of performance, product performance and that of entire Quality Management system.
All the outsourced processes are appropriately controlled to ensure product conformity and these have been identified and documented. However the responsibility of meeting customer requirements lies with the organization.
Documentation requirements.
User friendly system of Quality management system documentation ensures availability of:
a) Documented statements off quality policy and quality objectives.
b) A quality manual
c) Documented procedures required by the standard.
d) Documents needed to ensure effective planning, operation and control of processes
and
e) Quality records.
Documents described under a) to e) fulfill the requirements under IS/ISO/TS 16949 : 2002.
Quality Manual
( 1 ) The Quality Manual includes the scope of the quality management system, details of exclusion and justification (section 2.0), reference to the documented procedures list (Master document index), a description of the interaction between the processes and the company quality policy (Annexure).
The documented Quality System comprises the following:
A) Quality Manual
B) Documented procedures /Standard Operating Procedures
C) Work Instructions/Test Methods/Quality Secification/Manufacturing Specification/Standard Specification/Standard Requirement/Standard Calibration Instruction / Standard Checking Methods.
D) Control Plan, Forms and Records
( 2 ) The system procedures, work instructions and test methods are supplemented by specifications and drawings, written or visual reference standards of acceptability and verification methods at various stages of the process.
Control of documents
( 1 ) All documents and data relating to the requirements of Quality Management System are controlled either by hard copy or electronically. Prior to their issue they are reviewed and approved by authorized personnel. These controls ensure that :-
a) The relevant and current versions of necessary documents are available when required.
b) Obsolete documents are promptly removed from all points of issue or use.
Obsolete documents retained for legal and/or knowledge preservation purposes are suitably identified (stamped as “SUPERCEDED”.
c) Documents of external origin (documents generated outside the organization and received for use in the organization ) such as Indian / International Standards are identified and controlled. Whenever amendment to these standards take place, the revised standards are procured.
d) Changes or modifications to documents are reviewed and re-approved by authorized person.
e) The revision status is identified and recorded on each document.
f) The documents remain legible and readily identified.
i)Appropriate documents (e.g. Drawings, Standards, CAD, inspections instructions, test methods, work instructions, operational sheets, quality manual, system procedures, material specification and etc) and its supporting medium ( eg. Paper, magnetic, electronic or optical
ii) computer disc, photograph or master sample ) are available at all location where operations essential to the effective functioning of the quality system are performed.
Documented procedure is also established to assure the timely review, ( within two working weeks ) distribution and implementation of all customer engineering standards/specifications and changes. Record of date on which each change is implemented in production is maintained.
Records are updated as and when there is change in standards / specification or if these changes affect documents of production part approval process such as control plan, FMEAs etc.
Control of Records
( 1 ) Quality records are established and maintained to provide evidence of conformity to requirements and the effective operation of the quality management system. Quality Records shall remain legible, readily identifiable, and retrievable. Records also include customer-specified records, if any.
( 2 ) The company has established a procedure for the identification, storage, protection, retrieval, retention time, disposition and disposal of quality records. The control of records shall satisfy regulatory and customer requirements.
Production part approvals, tooling records, purchased orders and amendments are maintained for a length of time that the part (or family of parts) is active for production requirements plus one calendar year unless otherwise specified by the customers.
This requirement does not supersede any statutory requirements.
Customer Focus
Top management has established procedures to ensure that customer needs and requirements are determined and fulfilled with the aim of enhancing customer satisfaction Refer to doc. Customer Satisfaction Feed back form.
Quality Policy
Top management has defined and documented the appropriate company quality policy and objectives for, and commitment to quality
The company ensures that Policy is communicated, understood and implemented throughout the organization. It is reviewed at the Management Reviews for continuing, suitability and effectiveness.
Quality Objectives
( 1 ) Top management has ensured that the documented quality objectives, which are measurable and consistent with the quality policy, are established and maintained at relevant functions and levels within the company
( 2 ) The quality objectives and measurements shall be included in the business plan and used to deploy the quality policy. It should address customer expectations and be achievable within a defined time period
Quality Management System Planning
(1) The quality planning and objectives shall be consistent with the requirements of the quality system and following the techniques outlined in the Advanced Product Quality Planning and Control Plan reference manual, the Potential Failure Mode and Effects Analysis reference manual and the Production Part Approval Process manual and their respective documented quality system procedures [L-3-SOP-QA-01(APQP), L-3-SOP-QA-02(FMEA), L-3-SOP-QA-03(PPAP). L-3 –SOP-QA-04 (MSA)]
The documented system procedures for Advanced Product Quality Planning for new products and engineering changes are established and implemented by Production and Maintenance departments and followed by cross functional advanced product quality planning team. As applicable, this quality planning process covers the product cycle from development stage through to manufacturing processes, verification activities and servicing.
Integrity of quality management system is maintained when changes to quality management system are planned and implemented.
( 2 ) Planning activities are carried out with focus on defect prevention rather than defect detection and include applicable safety considerations in the product development, production processes and operational and training activities as well as ensuring that customer requirements are met.
( 3 ) The quality planning includes, as applicable: the development and review of FMEAs (for processes only), control plans, special characteristics, product safety and required resources, the overall compatibility of development, manufacturing processes and applicable standards and legal requirements. If applicable, FMEAs are reviewed and approved by customer. Sources of nonconformities identified by FMEAs and capability studies, are addressed by the APQP team, using mistake proofing methodology during planning of processes, facilities, equipment and tooling, and during problem solving if applicable.
( 4 ) Where required and prior to the acceptance of a contract of a new product, a feasibility review is conducted by qualified personnel in the Production and Quality Assurance departments in order to ensure that processing capabilities are available and do meet the requirements of the contract or order. Where applicable, the feasibility review is part of the contract review.
(5) As applicable, cross-functional teams develop control plans for the manufacturing of prototypes, pre-launch activities and full production of products. When required, control plans are approved by the customer. Control plans are reviewed and revised if a product or process is changed, if processes become unstable or non-stable or non-capable, or if verification activities are revised.
(6 ) Quality records of these planning activities are maintained as per applicable master list of quality records.
Responsibility for quality
Any person having responsibility for product quality shall have authority to stop the production when he comes to know or notices any non-conforming product is being produced. All the shifts will have personnel responsible for quality.
Quality management system performance
The management review shall also include all requirements of the ISO/TS 16949:2002 including customer specific requirements if any, and its performance trends as an essential part of the continual improvement process. The management review is conducted with a multi-disciplinary approach. The review output shall include any decisions and actions related to improving the effectiveness of the quality management system and /or improving product related to customer requirements and resources need.
Business Plan
At the beginning of each calendar year, the top management develops a comprehensive business plan for the year, including short (1-2 years) and long term (3 years or more) forecasting and planning. The business plan is a controlled document. In periodic management meetings, the plan will be reviewed and updated to reflect current status and to implement corrective action as required, and to ensure that the plan is adhered to and communicated throughout the organization as appropriate.
Product Approval Process
ACD shall establish Production Part Approval Process (PPAP) and shall fully comply with all the requirements set fourth in the PPAP reference manual. This includes engineering change validation, which verify that changes are properly validated.
Sample submission of production parts for consequent customer approval is the responsibility of the of the Sales department together with Quality Assurance department as per the methods and guidelines specified in the PPAP reference manual.
PPAP is requested for a part number, engineering change level, manufacturing locations, material suppliers and production process environment. Any changes to these conditions require customer notification and possible resubmission of production parts for approval As appropriate, PPAP shall be extended for ACD’s supplier/vendor.
Review inputs.
Review input includes information on current performance and improvement opportunities related to the following:-
a)Results of audits,
b)Customer feedback,
c)Process performance and product conformance,
d)Status of preventive and corrective actions,
e)Follow-up actions from earlier management reviews,
f)Changes that could affect the quality management system,
g)Recommendations for improvement.
Input to management review shall include an analysis of actual and potential field failures and their impact on quality and safety of environment.
Review outputs
Review output includes actions related to:-
a)Improvement of the quality management system and its process,
b)Improvement of product related to customer requirements,
c)Resource needs.
d)Results of management reviews are recorded.
Infrastructure
The company infrastructure ensures that all necessary resources are made available, to ensure that objectives and targets relevant to the provision of products and services, to its customers, are realized and product conformity is maintained. These resources include:
(1) Suitable buildings, workspace and utilities. (Process Control )
(2) Suitably maintained appropriate tooling (Tooling Management)]
(3) Suitably maintained process equipment (both hardware and software)
(4) Calibrated inspection and measuring equipment (Calibration and Verification of Inspection, Measuring and Test Equipment)]
(5) Computer hardware and software
(6) Communication media (including e-mail and internet access)
A multi-disciplinary approach is be used to develop facilities, processes and equipment plan in conjunction with the APQP process. Production facilities, equipment and processes are planned in the production quality planning stage. Lean manufacturing principles and the link to the effectiveness of existing operations should be focused.
The APQP team is assigned to identify relevant issues and define appropriate methods to measure the effectiveness of the production operation. The overall equipment effectiveness is measured.
Initial effectiveness evaluation of the production system is conducted in conjunction with the production trail run. The focus is on overall work plan, appropriate automation, operation and line balancing, storage, optimizing inventory level, ergonomics, etc. All new machine purchased will be subject to machine trial run.
The APQP team will evaluate the effectiveness of the initial production system and sign-off in quality planning once it is accepted.
In addition to the initial assessment in the quality planning phase, manufacturing capabilities and effectiveness are assessed regularly by the top management.
Tooling Management shall be established and maintained to control :-
Maintenance and repair facilities.
Storage, recovery and set-up
Tool change programs for perishable tools and tool modification, including tool design documentation.
Appropriate technical resources for tool and gauge design, fabrication, full dimensional inspection and system to track and follow-up on these activities if any of this work is subcontracted should be established.
Contingency Plan will be prepared to reasonably maintain the supply of products to customers in the events of an emergency.
Identification and Traceability.
The company has established a procedure for identifying the product, from receipt of materials and during all stages of production and delivery as mentioned in control plan for identification and treaceability.
The inspection and test status of products with respect to monitoring and measurement requirements, including raw materials, is identified, to indicate the conformance or nonconformance of products. When required by customer, additional verification/identification requirement shall be met Incoming Inspection and Testing, In-process inspection and Testing, Final Inspection and Testing.
Customer Property and Customer-owned Production Tooling.
The organization has established a procedure for identifying, controlling, protecting customer property as mentioned in control plan customer property.
The customer property received by the company is either the product drawings or the pattern. Proper records are maintained.
Delivery Performance
ACD is committed to 100% on-time shipment/Delivery to meet customer's production and service requirements. Delivery performance is monitored and corrective action is taken as required. Customers are informed of delivery problems as appropriate.
Control of monitoring and Measuring Devices (Calibration and Verification of Inspection, Measuring and Test Equipment)]
The company has determined and documented the monitoring and measurement to be undertaken and provided suitable devices to check evidence of conformity to specified requirements. Monitoring, measuring and test equipment is controlled, calibrated and maintained to ensure that measurement uncertainty is both known and consistent with the required measurement capability. Measurement system analysis is done as per the procedure and the analytical methods and acceptance criteria used conform to those in customer reference manuals (where required) on measurement systems analysis.
The measurements to be made and the required accuracy are identified on relevant documentation and the appropriate inspection, measuring and test equipment is made available
All inspection, measuring and test equipment is uniquely identified and calibrated / verified at prescribed intervals by equipment traceable to International or National Standards.
Calibration and Verification procedures are established for inspection, measuring and test equipment including equipment type, identification, calibration frequency, and acceptance criteria.
Through the use of calibration/verification records, the calibration/verification status of all inspection, measuring and test equipment is identified together with the results of previous calibration / verification checks.
Should inspection, measuring and test equipment be found to be out of calibration/verification, the validity of previous inspection results using that equipment are assessed and documented.
Adequate facilities are provided for the handling, preservation and storage of inspection, measuring and test equipment.
Inspection, measuring and test equipment is safeguarded from adjustments, which would invalidate calibration/verification.
When used in the monitoring and measurement if specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.
Records of calibration/verification activities of inspection, measuring and test equipment include any updates resulting from engineering changes, any nonconformance of calibration/verification, confirmation of successful calibration./verification as well as notification to the customer in case that suspect material has been shipped. Where applicable, employee owned equipment is included.
MEASUREMENT, ANALYSIS AND IMPROVEMENT
General
Monitoring, measurement and improvement processes are planned and implemented to demonstrate the conformity of product, to ensure the conformity of the quality management system and to continually improve the System. Methods used are documented in the Quality procedures, Control Plans, Work Instructions and Test Methods. Limited use is made of statistical techniques to analyze data, for discussion at management reviews. Besides, appropriate statistical tools for each process shall be determined during APQP and included in the Control Plans.
Monitoring and Measurement
Customer satisfaction
( 1 ) Information as to whether customer perceive that their requirements have been fulfilled are monitored at the management reviews. Trends in customer satisfaction and key indicators of customer dissatisfaction are defined and corrective and preventive actions are taken when required. The method used for obtaining this information are documented in the corrective and preventive actions procedures.
( 2 )Besides, customer satisfaction with the organization shall be monitored through continual evaluation of performance of the realization process.
( 3 ) Some of parameters used for customer satisfaction are given below:
Delivered part quality performance.
Customer disruptions including field returns.
Delivery schedule performance ( including premium freight )
Customer notifications related to quality or delivery issues.
( 4 ) ACD shall also monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for product quality and efficiency of the process.
Internal Audit (Internal Quality Management System Audit Procedures )]
( 1 ) Internal Quality Audits are conducted to verify whether quality activities comply with planned arrangements and to determine the effectiveness of the Quality System. The internal auditors shall be qualified to audit the ISO/TS 16949:2002 requirements, either by skills, educations or experience.
( 2 ) Audits are scheduled as given in the procedure on the basis of the status and importance of the activity. The audit shall cover all the ISO/TS 16949 requirements, ( including customer specific requirements, if any ) and all work shifts and work station / sites. Audits and follow-up actions are carried out in accordance with the documented procedures, by a trained auditor, who is independent of the area to be audited.
( 3 ) The results of the audits and any corrective actions are recorded and the personnel having responsibility for the area audited are notified, in order that corrective action may be implemented, without undue delay.
( 4 ) Re-auditing of deficient aspects is performed and further action taken, if necessary. Follow-up activities verify and record that the corrective action has been successfully and effectively implemented.
( 5 ) Results of internal audits form an integral part of the Management Review.
( 6) Besides, the quality system audit, manufacturing process audit and product audits are also planned and carried out. Specific check lists are prepared before the audit is conducted.. Internal Quality System Audit Procedure
(7) The internal auditors of the company are qualified to audit as per the requirements of IS/ISO/TS 16949 :2002.
Monitoring and Measurement of Processes
Monitoring and measurement of manufacturing processes
( 1 ) Within the procedures, work instructions, control plans, test methods or allied documents, the measurement of processes identifies:-
i) Characteristics which directly affect process performance
ii) The scope, type and frequency of measurement
iii) Methods for ensuring consistency, validity, review and timely access of quality measurement data
( 2 ) Operators in Production follow the above detailed documented operating or work instruction to ensure effective process monitoring. Established inspection activities as per control plans provide evidence of effective process control. All documented instructions are accessible at the workstation.
( 3 ) These methods demonstrate the ability of the processes to achieve planned results. When these planned results are not achieved, corrective action is taken to ensure conformity of the products.
( 4 ) The I/C Production is responsible for the implementation of processes according to Control plans and other applicable procedures in order to ensure that process capability or process performance is maintained according to customer approval of production parts via PPAP. Important occurrences during production are recorded. Control Plans are revised as appropriate if the degree of capability exceeds requirements. Reaction plans from the Control Plan are initiated by Production if processes are unstable or non-capable. Corrective action is taken as required. Reaction plans are approved by customer, if required.
( 5 ) If the customer specifies higher or lower capability or performance requirements, the APQP team will update the control plan after the necessary studies confirm that these requirements can be met.
( 6 ) Maintenance Dept. establishes and maintains documented procedures for the set-up of equipment and tooling by qualified personnel. The procedure, which is available to set-up operation includes first-off approval and last-off comparison, where appropriate.
(7) Records of effective dates of process changes, if any are maintained by Production.
(8) APQP team shall also identified the need of statistical process control for controlling and verifying process capability and product characteristics in production. SPC requirements are part of the Control Plan.
( 9 ) To control and verify process capability and special characteristics, statistical process controls activities are defined and implemented by production according to documented procedure and are followed by operators during processing of parts and products. Most of statistical process control for dimensions are being specified in the drawing by the customers.
( 10 ) During APQP process and as applicable, the need and type of statistical tools or each process are identified and determined and are included in the Control Plan.
( 11 ) Management and designated personnel in Production, Maintenance, Sales and Quality Assurance have the necessary knowledge of statistical concepts (variation, common causes, special causes and over adjustment) to identify the need of statistical process control and ensure its effective implementation.
Monitoring and Measurement of Product
( 1 ) General
It is the responsibility of Quality Assurance to establish and maintain documented procedure which specify in detail all verification activities to ensure that product received, in production and during production and products to be shipped, meet specified requirements. Verification activities are in accordance with the Control Plan.
( 2 ) Acceptance Criteria for Attribute Characteristics
If not otherwise specified and approved by the customer, acceptance criteria for data sampling are zero defect. Appropriate acceptance criteria for other methods are documented and approved by the customer.
( 3 ) Receiving Inspection and Testing
Incoming materials are not used or processed until they have been inspected or otherwise verified conforming to the specified requirements. Where incoming materials are required for urgent production purposes they are released after being identified and recorded, to ensure that they may be recalled at a later stage should they subsequently be found not to conform to the specified requirements. Suppliers are notified of all supplies, which fail to meet specified requirements.
The incoming quality system can form one or more of the following methods
· Receipt and evaluation of statistical data by ACD
· Receiving inspection and/or testing.
· 2nd. or 3rd. party assessment or audits of subcontractor site,
· Part evaluation by accredited laboratory.
(4 ) In-process Inspection and Testing
Work in progress is inspected and tested as required according to documented procedure. Process monitoring/control methods are used, where applicable, to establish conformance to the specified requirements. Jobs do not further progress until the required inspection and tests have been carried out. Any non-conforming works or items are identified and segregated, where possible, pending disposition. Processing will be done prevent defects rather than detect defect
( 5 ) Final Inspection and Testing.
Final Inspection and Testing, is carried out in accordance with control plan for final inspection to complete the evidence of conformance of the finished job to specified requirements. Jobs are not deemed complete until all the activities specified in the documented procedure have been satisfactorily completed.
If product is designated as "Appearance Items" by customer, to ensure quality, Production will ensure that all required equipment and a suitable environment is provided and properly maintained. This includes the appropriate lighting for evaluation areas, master for characteristics of finishing and appearance as well as trained and qualified personnel.
( 6 ) Layout Inspection and Functional Testing
As requested and defined by the customer, a layout inspection and functional testing of parts or products produced, is carried out. Inspection and test results are available for customer review upon request.
( 7 ) Manufacturing process and product audits
Each manufacturing process will be audited by internal auditor to determine its effectiveness. Prior to shipping of all product, the warehouse staff performs a visual inspection or Doc-Audit to ensure that the packaging, condition of packaging, labeling and other specified requirements are met and that the correct product is in the container(s). Besides, product audit shall also be planned to ensure the compliance of product requirement.
( 8 ) Inspection and Test Records
Records are maintained which demonstrate evidence of conformity, to defined acceptance criteria. These records indicate the authorizing release of product. For rejected product or material, the procedure for control of nonconforming product applies. All inspection and test records identify the inspection authority.
Control of Nonconforming Product
The company has established procedures to ensure that items or jobs, which are non-conforming, unidentified and/or suspected, are prevented from use. This control provides for identification, evaluation, segregation (where practical), disposition and notification to the functions concerned. The suspected and/ or nonconformance products shall be clearly indicated by using visual identification and/or quarantine areas.
The responsibility for the review and disposition of non-conforming items or work is assigned to specific personnel.
The company has established a procedure for the recording, investigation and analysis of customer complaints.
Non-conforming items are reviewed in accordance with the documented procedures and may be accepted, reworked to meet the specified requirements, repaired or scrapped.
Where appropriate, Production together with Quality Assurance analyze nonconforming product and the causes of non-conformity are identified and corrected. A prioritized reduction plan is established and results are monitored.
Product that has been reworked, is re-inspected as per Control Plans. The Quality Assurance and Production department are responsible to ensure that sorting and/or rework instructions are established and available to operators who perform the sorting and/or rework. No visible marks during re-work are acceptable on products for service applications, unless authorized by the customer.
When nonconforming product is detected after delivery or use by the customer, action will be taken appropriately to the effects or potential effects of the nonconformity. Customer will be informed promptly.
Quality Assurance Department obtains PPAP approval for changes of product or process. Requested or proposed changes from suppliers are evaluated and approved prior to submission to the customer for approval. Customer authorized quantities and expiration dates of engineering deviation are recorded and controlled by Production department. This control includes compliance with original requirements after the deviation expires. Product shipped with authorized deviation is identified as such on all containers or packaging.
Analysis and Use of Company-Level Data
Data is collected from relevant sources such as records from internal audits, corrective actions, nonconforming product, supplier performance, customer complaints and customer feedback and analysed to provide information relating to
a)Customer satisfaction
b)Conformity to product requirements
c)Characteristics and trends of processes and products including opportunities for preventive action and
d)Suppliers.
Based on these analysis results, trends of product quality, the cost of poor quality, the effectiveness and efficiency of operational activities and customer satisfaction are established. Timely corrective and preventive actions are taken as required, including benchmarking, if possible.
Trends of quality, process performance and current quality levels for key product and service features are compared with objectives which may lead to action to support the following
a)development of priorities for prompt solutions to customer related problems
b)determination of key customer related trends and correlation for status review, decision making and longer term planning
c)information system for timely reporting of product information arising from usage.
Improvement
Continual Improvement
( 1 ) The company has established programs to continuously improve the quality, service (including timing, delivery) and price that benefit all customers.
( 2 ) The company continually seeks opportunities to improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive action and management review.
(3) The Management Representative is responsible to ensure that a comprehensive continual improvement philosophy and approach is implemented throughout the organization and that functions concerned have the necessary knowledge of quality improvement concepts.
( 4 ) The APQP Team, coordinate quality activities and projects for innovative improvements as required Employees are encouraged by management to participate in this activity.
( 5 ) It is the responsibility of the APQP team to continuously improve product characteristics with priority on special characteristics. It is the responsibility of Production and Quality Assurance Department to establish a prioritized action plan in order to continually improve process which is stable, capable and meet performance requirements. The performance data of product quality and operational activities are analyzed in order to take required actions for the improvement of quality, effectiveness and efficiency. These quality improvement activities shall include the improvement of product characteristics with focus on cost elements or price. All customers shall be benefited from these continuous improvement efforts.
( 6 ) It is also the responsibility of the Head of Quality Assurance Department to identify the need for improvement projects for product quality and productivity, to implement these projects or to refer them to the APQP team, as appropriate.
( 7 ) As applicable, it is the responsibility of the Management Representative or Head of Dept./Sections to ensure that the members of the APQP Team and other functions involved in the continual improvement process have the knowledge of the measures, methodologies and techniques required for continuous improvement activities.
Corrective Action
( 1 ) The company has an established procedure for corrective action, to eliminate the cause of nonconformities and prevent recurrence. It includes the following;
i) Reviewing nonconformities including customer complaints
ii) Determining the causes of nonconformities
iii)Evaluating the need for action to prevent recurrence
iv)Determining and implementation action needed
v) Recording the results of action taken and reviewing effectiveness
Documented problem solving methods are available to personnel and are applied as appropriate. For External problems or deficiencies, the method or technique prescribed by the customer is used.
As appropriate, corrective and preventive actions are supported by mistake proofing.
Corrective action impact shall be studied and the implemented corrective actions shall be extended and applied to other similar activities, processes and products, to eliminate the cause of a non- conformity.
QA department shall re-inspect and analyses products returned from customers and dealerships. If appropriate, corrective action that could include process changes is taken to prevent recurrence.
Records are maintained and are made available to the customer upon request.
Preventive Action
( 1 ) The company has an established procedure for preventive action, to eliminate the causes of potential nonconformities and or other undesirable potential situation and prevent its occurrence. Preventive actions shall be appropriate to the effects of the potential problems. It includes the following :-
i) Evaluating and analysis of operations, records, customer complaints to detect and eliminate potential causes of non-conforming product.
ii) Initiating preventive actions and application of controls to ensure they are effective.
iii) Reviewing and implementing changes to procedures resulting from preventive actions.