SECTION 1.0: PROCESS AUDIT STRATEGY AND PLANNING

Transcription

1 SECTION 1.0: PROCESS AUDIT STRATEGY AND PLANNING a. Have Annual Quality Targets been agreed and submitted to Electrolux or other customers? 7.7f Objectives and quantifiable targets are required to be established for improvements along with records demonstrating progress made in achieving them. b. Have the trends in meeting the above objectives been analysed and action taken where the targets are not being achieved? 7.7f 8.4, The organization is required to monitor it s ability to meet Quality Targets and identify where improvements need to be made, developing clear action plans for improvement where targets are not met. c. Is there a system to establish quality costs that monitors internal failures, external failures, prevention, and appraisal? 7.7a - The organization is required to establish a system for collection, analysis and monitoring of quality related costs. Methods of financial reporting may include, for example: Determination of quality related costs o Prevention o Inspection and testing o Internal and external failure Process related costing o Conformity and non-conformity costs based upon identified processes Quality related losses o Internal and external material losses (non-fulfilment of quality requirements) d. Have specific improvement projects been identified? e. Are there appropriate measurables for improvement projects? 7.7e f f. Have Quality Plans been prepared defining controls for new product introduction and changes to existing products resulting in approved control plans? The method of determination of quality costing is required to be defined by the organization. The supplier is required to continually improve on the effectiveness of the quality, service, process, product and quality management system through use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review or other appropriate mechanisms. Evidence is to be made available to demonstrate that the organization has identified specific improvement projects based upon such information. Improvement projects defined above need to have specific milestones and targets. The success or otherwise of such projects need to be evaluated and monitored by management. The organization is required to plan and develop the processes needed for product realisation. This requires that the organization adopts some form of Advanced Product Quality Planning process is in place, which ensures that product and process characteristics that ensure products meet customer and regulatory requirements are identified at the earliest possible stage. The end result of this process will be some form of control plan defining the product and process requirements required to achieve conformance of product to specified requirements. Such processes shall also ensure the effective communication of changes following changes to specified requirements. EL29002A 2006 Interps_Rev.a Page 1 of 14

2 SECTION 1.0: PROCESS AUDIT - SECTION NAIRE (Cont d) g. Is there an effective process for ensuring Electrolux specifications and changes to them are reviewed and communicated to the functions concerned? h. Does an effective process exist for communicating changes to products and processes where these can potentially affect the form, fit or function of the product? i. Are Process Risk Assessment/F.M.E.A. prepared and utilized (after definition of process flow) with input from all relevant departments? j. Is there evidence that corrective actions resulting from Process Risk Assessment/F.M.E.A are implemented and that such Risk Assessment are updated and re-issued at product or process change? 7.2g g k - 7.2l - The organization is required to have a process to ensure the timely review of customer engineering standards and specifications and to ensure the timely control and deployment of such instructions through to product realization. Where changes are made, the effect of the change needs to be evaluated and effectively deployed to ensure the integrity of products and processes. This will normally result in the revision and modification to control plans or other process/product documentation. FMEA s (Failure Mode and Effect Analysis) are expected to include definition of process or product attributes, potential mode of failure and assessment of severity, potential cause, likelihood of occurrence, Controls to prevent or detect and likelihood of detection, action to be taken to mitigate potential problem along with responsibilities, timescales and closure of actions. Alternative methods of risk assessment may be utilised providing they fulfil the same intent. Risk assessments/fmeas need to be reviewed and updated following changes in input criteria. In addition, process changes arising from such changes need to be followed through into the product realization processes. k. Have Electrolux or other customer s preliminary process capability requirements been met? 7.2q - EL29003 requires that Preliminary Process Capability requirements are performed on all critical process characteristics with a target to achieve minimum potential process capability of 2.0 Ppk. Ppk 1.66 is acceptable for a limited period (max 1 year). Customer preliminary process capability requirements are required to be identified, measured and corrective action taken in order to achieve target values EL29002A 2006 Interps_Rev.a Page 2 of 14

3 SECT. 2.0 PURCHASING. a) Are suppliers regularly assessed and selected for quality system and performance capability? 7.3i The organization is required to evaluate and select subcontractors on the basis of their ability to meet requirements including quality system and any specific quality assurance requirements. The supplier is required to define the type and extent of control exercised over subcontractors, dependent upon: the type of product impact of subcontracted product on the quality of final product quality and audit reports and/or quality records of the previously demonstrated capability and performance of subcontractors (where applicable) b) Is there an effective system for ongoing monitoring of supplier performance capability? These controls are to be applied to raw material, components, subcontract manufacturers and services that may affect the quality of the product (e.g. calibration, testing, transportation, offsite storage etc). The organization is required to monitor supplier performance on an ongoing basis to defined requirement to ensure continued acceptability of supplied product c) Are procedures established ensuring corrective action on Supplier Classification and Performance? d) Are purchasing specifications issued by the organization to sub suppliers adequately defined? e) Is there an effective system for approval/ validation of parts and where necessary, processes both internal and external prior to commencement of production at the supplier s facility? f) Is there a system for management of engineering changes provided to and received from suppliers? 7.3j k The organization is required to ensure that where problems are identified by the organisation with supplier performance that effective action is taken to improve performance. Purchasing information is required to describe the product to be purchased, including, where appropriate Requirements for approval of product, procedures, processes and equipment, Requirements for qualification of personnel, and Quality management system requirements. The organization is to ensure the adequacy of specified requirements prior to their communication to the supplier. An initial sample submission is required to be provided by each sub-supplier of component parts where specified in the control plan or required by customer. The results of the first sample inspection are to be documented and should contain statements on: Geometry Material (special attention to hazardous material) Function Reliability For important characteristics, proof of capability is to be produced. The scope, documentation and requirement for any required witness inspections at the sub-contractor or third party premises is to be coordinated and agreed between the supplier and the subcontractor in line with customer requirements. A system needs to be established to ensure that relevant engineering changes are communicated to and responded to suppliers. EL29002A 2006 Interps_Rev.a Page 3 of 14

4 SECT. 3.0 CONTROL OF PRODUCTION a) Are procedures and work instructions defining manufacturing operations in use that communicate requirements to all people involved in this process? 7.2a 7.5.1b Documented procedures/work instructions are required which define the production processes and activities where the absence of such documentation or instruction would adversely affect quality. Procedures and work instructions may be in any format, as procedures, control plans, drawings, specifications and in any media: e.g. written documents, on-line instructions or menus. The system must ensure that these documents are distributed to all personnel who require the information contained within them. b) Do procedures/work instructions/control plans specify requirements for the operation, inspection, testing, gauging and recording results, including processes with special characteristics? c) Are process flow charts available and do they reflect actual process layouts and controls? 7.2d - 7.2f - d) Are necessary instructions available at the workstations? 7.2b - e) Do employees perform operations in accordance with work instructions and other relevant requirements? 7.2n 7.2p f) Are special processes identified and subjected to planned complementary activities to ensure that products shall meet product specifications? o Note: the marks allocated to this section relate only to the content of procedures/instructions and the mechanism by which the requirements are communicated to the personnel concerned. Implementation issues are dealt with in section 3e) below. Requirements for inspection, measuring and test equipment used for product or process monitoring are required to be defined in the control plan or in documented procedures. Note: the marks allocated to this section relate only to the content of procedures/instructions and the mechanism by which the requirements are communicated to the personnel concerned. Implementation issues are dealt with in section 3e) below. The supplier is required to provide a detail description of the steps involved in each production process (including sub-contracted processes). This would normally be in the form of a process flow chart, however may be defined in procedures, instructions or process flow design. Job Instructions or visual aids should be available at the time needed without disruption to the job being performed by the operator, normally adjacent to the workplace. Instructions required by section 7.2a), c), d), e), f) and h) above are required to be implemented effectively. Note: this section applies to the implementation of the instructions/procedures. Issues concerning the content and adequacy of the documents and data themselves would be highlighted in the above sections. Special processes are processes the results of which can only be verified (checked) on the product at a later time, or not at all. Examples include painting, welding, soldering etc. This question relates to the availability and appropriateness of resource in order to be able to conduct all production processes. For example: Sufficient number of personnel Adequate qualification/skills of personnel Capability and availability of equipment and monitoring devices EL29002A 2006 Interps_Rev.a Page 4 of 14

5 SECT. 3.0 CONTROL OF PRODUCTION (Cont d) g) Are appropriate controls and criteria specified, implemented and recorded for production start-up as well as product, tooling and process changes? 7.2e - Criteria are required to be defined for approval of production start up and acceptance/rejection of initial production such as to provide confidence in the ongoing production runs. EL29003 specifies criteria for submission and approval of initial samples. h) Are the required resources for normal and special processes available where needed, and are they appropriate for the type of work being accomplished? 7.2o 6.1 The organization is required to ensure that adequate resources are provided in support of manufacturing, assembly and service processes i) Is the work environment clean and well organized? j) Are statistical methods implemented as required by control plans? k) Where statistical methods are employed, is the process capability index CPK>1.33 on all significant/relevant parameters? 7.2u i - 7.2j - l) Are control charts maintained and reviewed with highest priority given to special characteristics? 7.2t - The environmental conditions must be tailored to the work being performed such as to ensure that products comply with requirements and are not contaminated or otherwise affected. Consideration should be given to: o Definition of the responsibilities for order and cleanliness o Clean, intact transport and operating equipment o Adequate environmental control for measuring and verification practices o Clean, well-illuminated workplaces and inspection places o Clear identification systems o Clear, ordered, if possible synchronous material flow o Appropriate disposal containers Appropriate room and storage conditions El29003 requires that the supplier utilize statistical process control techniques. Where the supplier utilizes other statistical techniques (e.g. statistical sampling) these are required to be based on valid statistical practice. Electrolux requires that the supplier utilize statistical process control techniques, with process capability index exceeding EL29003 requires that ongoing process capability performance shall aim to exceed a minimum process capability performance of 1.67Cpk. The Supplier must demonstrate the commitment to reach the EL29003 requirement in the annual plan. Where statistical process monitoring techniques are utilized, appropriate control charts are required to be maintained, capability monitored and action taken where out of control or suspect conditions are identified. Data from control charts must be utilized to continually improve process capability and identify opportunities for improvement with highest priority given to special characteristics. EL29002A 2006 Interps_Rev.a Page 5 of 14

6 SECT. 3.0 CONTROL OF PRODUCTION m) Are special causes of variation investigated and appropriate action taken? n) Have the Electrolux ongoing process performance requirements been meet? o) Are there written procedures for handling, storage, packaging, delivery, and preservation of product? 7.2s r 7.5.1e 7.3m The organization is required to initiate corrective action for characteristics identified on the Control Plan, which are either unstable or non-capable. Reaction plans should include containment of process output and 100% inspection. A supplier corrective action plan shall then be completed indicating specific timing and assigned responsibilities to assure that the process becomes stable and capable. The plans are to be reviewed with and approved by the customer when so required. The organization is required to analyse production and non-conformance data for trends and take appropriate corrective action even in cases where Statistical process control methods are not required to be implemented This covers monitoring and review of compliance with customer requirements. For example targets for defect rates, process capability requirements, service call rates, delivery performance etc. The supplier is required to establish and maintain documented procedures for handling, storage, packaging, preservation and delivery of product. In order to avoid damage or deterioration in quality (e.g. through dirt, corrosion, chemical reaction) written instructions for product handling are to be raised Special attention should be paid to, for example: Cleaning and preservation Methods of transport (temperature, vibrations etc) Protective measures Effects of temperature and humidity Padding Secure fixing Collective packaging Instructions for handling (for storage and delivery) It must be ensured that products are identifiable at all times during transport and storage. Customer requirements must be complied with. Consideration should be given to: Identification in accordance with specification requirements Revision status Clear and permanent referencing of identification and/or accompanying documents to the product (processing stage, inspection status) Delivery/dispatch labelling Expiry date/shelf life p) Does the organization control packaging processes properly to ensure product conformance to specifications? 7.1e This question relates to the implementation of the instructions provided in section 3.0p above EL29002A 2006 Interps_Rev.a Page 6 of 14

7 SECT. 4.0 MONITORING AND MEASUREMENT a) Have quality plans and/or procedures for verification of incoming product been implemented to ensure conformance to specified requirements? 7.3a The organization is required to establish and maintain documented procedures for incoming inspection and testing activities in order to verify that the specified requirements for the product are met. The required inspection and testing, and the records to be established, shall be detailed in the quality plan (Control Plan) or documented procedures. b) If incoming product is released for urgent production purposes, are products identified and recorded in order to permit immediate recall and replacement due to nonconformance to specified requirements? 7.3b - In the event that the organization does not perform incoming inspection, sufficient evidence of process capability of the supplier will be required in order to justify waiving incoming inspection arrangements. Where incoming product is released for urgent production purposes prior to verification, it is required to be positively identified and recorded in order to permit immediate recall and replacement in the event of nonconformity to specified requirements. c) Are written procedures in use to control in process inspection and testing (including special process parameters) and are they in accordance with specified requirements? 7.3c d) Are written procedures in use to control final inspection and test operations and do they conform to specified requirements? 7.3e The organization is required to inspect and test the product as required by the quality plan (Control Plan) and/or documented procedures. This also applies to the monitoring of process parameters (e.g. temperature, pressure, feed speed, product/personnel qualifications as applicable) which relate to special processes are properly controlled to ensure that the product meets specified requirements. The organization is required 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. The quality plan (Control Plan) and/or documented procedures for final inspection and testing must ensure that all specified inspection and tests, including those specified either on receipt of product on inprocess, have been carried out and that the results meet specified requirements. e) Is there evidence that product conforms to specified requirements and do these documents contain proper authorizations? 7.3f The organization is required to establish and maintain records, which provide evidence that the product has been inspected and/or tested. These records must show clearly whether the product has passed or failed the inspections and/or tests according to defined acceptance criteria. f) Has the organization planned and implemented arrangements to ensure that the product continues to meet requirements over it s intended lifecycle (e.g. sampling, product audits, reliability evaluations, endurance testing, as applicable)? - - Consideration needs to be given to ensuring the product continues to meet requirements into the future. The mechanism by which this is done is up to the organization, however the system needs to provide ongoing assurance of product integrity throughout its intended life. EL29002A 2006 Interps_Rev.a Page 7 of 14

8 SECT. 4.0 MONITORING AND MEASUREMENT (Cont d) g) Is all product audit information continually reviewed for corrective action and continuous improvement? 7.3g - h) Is the identification of inspection and test results, including special processes, maintained throughout to ensure that only conforming goods are released for use? i) Are there records that all product has passed the inspections and tests as defined by the acceptance criteria and is the authority identified who is responsible for the release of the product? j) Are product On Hold and recall/rework procedures and instructions used in the event that the organization s process parameters are found to be outside of specified requirements? k) Does the organization have a process to ensure that Electrolux authorization is received in the event that nonconforming material is shipped? 7.5a h d o - The organization is required to ensure that final products meet customer requirements. This may be by packaging/labelling audits or inspections. The data arising from such verifications must be recorded, analysed and where trends or problems are identified, effective corrective action must be taken to remove the root cause of the problem and to promote continuous improvement. The system shall ensure that products are unambiguously identified in every stage of the material flow, also with regard to their operational state, inspection and testing and modification status in order to avoid confusion. For products with limited shelf life, the storage limitation must also be identified. The identification of products must be effective in all production in all production areas from entry until its departure. This may achieved by means of, e.g.: Accompanying product documents Tags Markings, numberings Bar codes Stampings Labels Inspection and test reports Records are required to identify the authority responsible for the release of the product prior to dispatch. No product shall be dispatched until all the activities specified in the quality plan (Control Plan) have been satisfactorily completed and the associated data and documentation are available and authorized. The organization is required to hold product until the required inspection and tests have been completed or necessary reports have been received and verified, except when product is released under positiverecall procedures. Instructions are required that ensure that, in the event that process parameters or other controls cast doubt on the conformance of the product, that the supplier will assess the impact of these variances in terms of the risk and, if necessary, recall the product. The organization is required to ensure that clear processes are defined to control of shipment of nonconforming materials including those subject to waiver or concession. Such processes are to accommodate customer authorization requirements and clear identification of the status of shipments and individual lots prior to shipment. EL29002A 2006 Interps_Rev.a Page 8 of 14

9 SECT. 5.1 IDENTIFICATION AND TRACEABILITY a) Has a formal system been established to identify product and it s constituent components at all stages from receipt through to dispatch? Documented procedures are required to describe the method by which identification is maintained. These requirements could be fulfilled by definition of identification requirements in the control plan, drawings, specifications or other documentation. b) Is a traceability system applied to all the relevant process parameters, raw material, components and parts? 7.1a b/c Identification of products means the clear and traceable identification through subject number, part number or comparable and of the revision status where this may affect fit form and function of the product. Identification is expected to be maintained in an appropriate manner for all items at all stages of production and shall ensure that products, constituent components and associated consumable items are unambiguously identified in every stage of the material flow. Traceability of product to source and to customer is required to be performed as required by customer contract, product specification or legal requirement. The supplier is required to consider the need for traceability in terms of risks during the quality planning process and specify requirements in quality system documentation/control plans or associated documentation. Note: Evidence must be available to demonstrate that the supplier has considered the need for traceability in terms of considering the risks associated with lack of traceability even if it is not a specified requirement SECT. 5.2 MATERIALS MANAGEMENT a) Are all homogeneous batches of components kept separate throughout the organization? b) Are appropriate systems in place to ensure that product and associated materials are properly stored at all production stages including the use of First-in, First-out (FIFO) systems where appropriate? 7.1d Homogeneous batches of manufactured products are required to be separated and identified in some manner as required by the control plan or equivalent documentation. Critical or safety critical functional part/components are required to be separated and controlled as required by the control plan. First in first out (FIFO) and/or consequent separation of lots and batches serve as supporting systems in order too prevent mixing of various manufacturing periods. The FIFO principle shall prevent products or consumables (e.g. paints, solder fluxes etc) with various production dates or revision status being mixed. EL29002A 2006 Interps_Rev.a Page 9 of 14

10 SECT. 5.3 PERSONNEL AND TRAINING a) Has a system been established to identify training needs and conduct training of all personnel performing activities affecting quality? 7.7c The supplier is required to establish and maintain a system for identifying training needs and provide for the training of all personnel performing activities affecting quality. b) Are personnel performing specific assigned tasks qualified on the basic of appropriate education, training and/or experience? 7.7d The system for training should include: Determination of the necessary competencies for personnel performing work affecting quality Provision of training or other actions to satisfy these needs The evaluation of the effectiveness of the actions taken Maintenance of appropriate records of education, training, skills and experience EL29002A 2006 Interps_Rev.a Page 10 of 14

11 SECT. 6.0 MAINTENANCE a) Is there a planned maintenance system including maintenance schedule, defined maintenance criteria, assigned responsibilities and records? 7.2v 6.3 A schedule is required to be developed identifying planned maintenance intervals and responsibilities for maintenance.. b) Is maintenance conducted at the prescribed frequencies for all equipment? 7.2x 6.3 The organization is required to demonstrate that maintenance activities are performed in accordance with the planned schedule. c) Are maintenance records evaluated for process capability improvement? 7.2w - d) Are replacement parts identified and available for key manufacturing equipment? 7.2y - The effect of maintenance activities are to be reviewed in the light of improving the ongoing process capability/production results. This also allows optimization of frequency and degree of maintenance performed. The supplier is required to perform preventive maintenance rather than simple planned maintenance. The organization is required to identify key replacement parts required to ensure production capacity can be maintained. e) Is there a planned maintenance system that includes Predictive maintenance methods such as TTF and TTR? 7.2z - The organization is required to assess machine uptime/downtime and adopt predictive maintenance if this assessment indicates excessive lost time or significant negative trends. TTR = Time to Repair, TTF = Time to Failure. These methods should include a review of appropriate items such as the manufacturer s recommendations, tool wear, optimization of uptime, correlation of SPC data to preventive maintenance activities, important characteristics of perishable tooling, fluid analysis, infrared monitoring of circuits and vibration analysis EL29002A 2006 Interps_Rev.a Page 11 of 14

12 SECT. 7.0 CALIBRATION a) Has inspection, measuring, and test equipment (including software when appropriate) been provided that is capable of the required accuracy and precision? 7.4b 7.6 The organization is required to determine the measurements to be made and the accuracy required, and select the appropriate inspection, measuring and test equipment that is capable of the necessary accuracy and precision; Where test software or comparative references such as test hardware are used as suitable forms of inspection, they are required to be checked to prove that they are capable of verifying the acceptability of product. b) Is Measurement System Analysis (MSA) conducted for all gages, measuring, and test equipment, noted on the control plan? 7.4f - Appropriate statistical studies are required to be conducted to analyse the variation present in the results of each type of measuring and test equipment system referenced in the control plan. The analytical methods to be utilized are to cover bias, linearity, stability, repeatability and reproducibility studies. Other analytical methods may be used if formally agreed with the customer. c) Are appropriate criteria used for acceptance of measuring equipment? d) Do systems ensure that calibration is traceable to National/International Standards? e) Is the inspection, measuring, and test equipment (including software when appropriate) calibrated at prescribed intervals, in the correct environmental conditions? f) Are inspection, measurement, and test equipment properly handled, preserved, and stored to maintain calibration and fitness for use? 7.4d e g h 7.6 See EL29003 for gage R&R limits Acceptance criteria for judging whether inspection, measuring and test equipment criteria are required to be defined, such as to ensure that the equipment is capable of making the measurements required. Inspection, measurement and test equipment is required to be calibrated against certified equipment having a known valid relationship to internationally or nationally recognized standards. Where no such standards exist, the basis used for calibration shall be documented. This activity may be performed by the supplier or by an external laboratory which can demonstrate competence to perform the work required (e.g. accredited to ISO/IEC or equivalent, a national standards laboratory, the original equipment manufacturer, laboratory specified by the customer etc) The organization is required to calibrate inspection, measuring and test equipment in a suitable environment and adjust them as necessary at prescribed intervals. Compensations are required to be made where the environment in which the calibration was conducted differs from the location where the measurement is to be made which, if ignored, would affect the measurements made. The organization is required to ensure that the handling, preservation and storage of inspection, measuring and test equipment is such that the accuracy and fitness for use is maintained; g) Are appropriate actions, including Electrolux notification, taken on both product and process when inspection, measurement, or test equipment is found to be out of calibration? 7.4i 7.6 The organization is required to assess and document the validity of previous inspection and test results when inspection, measuring or test equipment is found to be out of calibration EL29002A 2006 Interps_Rev.a Page 12 of 14

13 SECT. 8.0 DOCUMENTATION CONTROL AND RECORD MANAGEMENT a) Does the system for document control Include review, approval, issue dating and distribution of documents and procedures? (this must include control of relevant computer software, masters, and Electrolux furnished drawings)? 7.2g Procedures/instructions are required for control of all documentation, which may affect product or service quality. Such documents (including software) are required to be reviewed and approved for adequacy by authorized personnel prior to issue. A master list or equivalent document control procedure identifying the current revision status of documents is required to be established such as to preclude the use of invalid and/or obsolete documents. b) Has an effective system been implemented to handle engineering and process changes to ensure that they have been properly approved and implemented? Engineering changes are required to be properly evaluated, approved and implemented effectively. c) Are obsolete documents immediately withdrawn from all points of use? 7.5d 4.2.3g Controls are required to ensure that invalid and/or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use; d) Has the organization established and maintained procedures for identification, collection, indexing, filing, storage, maintenance, and disposition of all records affecting product and system quality? 7.5b 7.3p The supplier is required to establish and maintain documented procedures for identification, collection, indexing, access, filing, storage, maintenance and disposition of quality records. These records are required to demonstrate conformance to specified requirements and the effective operation of the quality system. Pertinent quality records from subcontractors should be considered as an element of this data. e) Are retention times for records established and recorded? 7.5c Retention times of these records are required to be agreed and in accordance with customer requirements and/or normative and safety reasons where specified for records defined in section 7.5b) above f) Is a system applied to ensure that records are easily available when applicable (per year, product, test type, etc. for review by Electrolux upon request? 7.5e Records are required to be made available customer by customer for evaluation by the customer or the customer s representative for an agreed period. EL29002A 2006 Interps_Rev.a Page 13 of 14

14 SECT. 9.0 CORRECTIVE ACTION AND IMPROVEMENT a) Have procedures been established, and documents maintained for investigating the cause of nonconformance and the corrective action needed to prevent recurrence? b) Are the causes of non-conformances investigated and the results documented? c) Is analysis and corrective action implemented and recorded when problems are identified on statistical charts or in capability studies? 7.6a e 8.5.2b 7.6j - The organization is required to establish and maintain documented procedures for implementing corrective action in order to determine the root cause of identified problems and action to be taken to prevent recurrence. Any corrective or preventive action taken to eliminate the causes of actual or potential nonconformities shall be to a degree appropriate to the magnitude of problems and commensurate with the risks encountered.. The organization is required to investigate of the cause of nonconformities relating to product, process and quality system, and recording the results of the investigation as an input to the corrective and preventive action processes. Such investigations are required to be documented. Where the organization utilizes statistical methods such as control charts or capability studies, the resulting data shall be analysed and utilized to identify known or potential problems and to identify corrective/preventive actions to rectify or anticipate problems. Such analysis and resulting actions is required to be recorded. d) Are appropriate corrective actions developed to eliminate the causes of the non-conformance? 7.6b The organization is required to determine the corrective action needed to eliminate the cause of nonconformities. e) Does the organization use a disciplined problem solving methods? 7.6c - The organization is required to utilize disciplined problem solving methods to determine and eliminate root causes. f) Are the customer complaints and reports of nonconformances handled effectively? 7.6d 8.2.1/ 8.3 The organization is required to effectively handle customer complaints and reports of product nonconformities in order to provide resolution and as an input to corrective action processes. g) Is the effectiveness of corrective action verified? 7.6f The organization shall ensure application of controls to ensure that corrective action is taken and that it is effective h) Are Electrolux or other customers returned parts analysed and are corrective actions initiated as appropriate? 7.6g The organization is required to analyse field and customer returns in order to determine root causes and implement effective corrective and preventive actions to prevent recurrence. i) Are non-conformance reports, e.g. product quality, deviation, audit results, quality records, etc. used to develop preventive actions? 7.6h The organization is required to use of appropriate sources of information such as processes and work operations which affect product quality, concessions, audit results, quality records, service reports and customer complaints to detect, analyse and eliminate potential causes of nonconformities. j) Are the relevant information on actions taken including changes to procedures submitted for management review? 7.6i 5.6.2d The organization is required to ensure that relevant information on actions taken is submitted for management review. EL29002A 2006 Interps_Rev.a Page 14 of 14