QUALITY MANAGEMENT HANDBOOKMeasuring Analysis and Improvement.docx

1、QUALITY MANAGEMENT HANDBOOKMeasuring Analysis and ImprovementMeasuring, Analysis and ImprovementTable of Contents8.1 General 28.2 Monitoring and measuring 38.2.1 Customer satisfaction 38.2.2 Internal audit 38.2.3 Monitoring and measuring of processes 58.2.4 Monitoring and measuring of the product 68

2、.3 Control of faulty products 108.4 Data analysis 108.5 Improvement 118.5.1 Planning continuous improvement 118.5.2 Corrective and preventative measures 128.6 Other applicable documentation 148.1 GeneralPlanned measuring, monitoring and analysis of measuring results and improvements should ensure th

3、at the products conform with the product requirements, that the processes (those for product realisation, as well as in the administrative sector) are monitored and controlled, and that efficiency of the processes and their results are measurable and assessable. Planning should ensure an organised i

4、mplementation and comparability of measurements. Recording of the monitoring and measuring results ensures that the measurements can be verified and traced. Analysis of data serves the performance evaluation and derivation of improvement measures.Scope of validityAll definitions in this chapter are

5、applicable for products and production processes, as well as for all business processes.Responsible functional areasAll business sectors.TermsVerification is the provision and confirmation of evidence which proves that defined requirements have been fulfilled.Validation is the provision and confirma

6、tion of evidence which proves that the requirements for a specific intended use or a specific intentional application have been fulfilled.Conformity is the fulfilment of a requirementAn error is failure to fulfil a requirement (non-conformity)A preventative measure is a measure which is implemented

7、to rectify the cause of a potential error, or another, potentially undesired situation.A corrective measure is a measure implemented to rectify the cause of a detected error, or another detected undesired situation.8.2 Monitoring and measuring8.2.1 Measuring and monitoring of customer satisfactionDe

8、termining efficiency of the QM systems is achieved, amongst other things, by measuring customer satisfaction. The customer surveys are conducted by the sales department by way of customer survey“ forms to be completed in writing. Data for measuring customer satisfaction is implemented in the managem

9、ent evaluation. Customer satisfaction relates directly to the end buyer or the authorised dealer.8.2.2 Internal auditPurpose:Internal audits are periodical checks of the quality management system for completeness, efficiency and usefulness. At the same time, they are designed to monitor compliance o

10、f the quality instructions, and where necessary, to pinpoint vulnerabilities, determine their causes and implement corrective measures.Scope of validity:This procedure of the internal system audit is applied by all internal positions within the company involved with product development.Definition of

11、 terms:System audit: Assessment of efficiency of the quality management system or its elements by way of an independent analysisAuditor: Person responsible for the implementation of a quality audit Quality audit: Assessment of efficiency of the quality assurance by way of analysis of a specific numb

12、er of end products and/or parts, or assessment of the quality assurance by way of assaying expertise of the personnel, and compliance and usefulness of certain procedures.Procedure:The company management has hereby decreed that scheduled and unscheduled internal system audits are to be implemented i

13、n accordance with the following scope:Scheduled system audits are to be implemented in accordance with an audit program devised by the QA management. This provides information regarding- the areas which are being assessed,- deadlines of the system audits (including subsequent audits necessary for th

14、e monitoring of corrective measures)Unscheduled system audits and quality audits then become necessary wherever- essential changes in the QM management and procedural elements have been initiated or- there is a risk that quality requirements for the product are no longer being fulfilled- deviations

15、or serious findings have been ascertained in the QM system or its elements following the implementation of a scheduled system audit.Sales and shipping audit:Audits of these sectors are included within the implementation of the COP-inspections.The capitals and procedures defined in the QM-handbook ar

16、e to be assessed: - Quality management system- Responsibilities of the management- Management of resources- Product realisation- Measuring, analysis and improvementIf the aforementioned QM elements have a direct influence on product safety, on the environment or on working safety or health protectio

17、n, relevant priority should be accorded to the assessments.The assessment also encompasses- a review of specifications prescribed by the individual specialist areas for implementation of the measures applying the quality requirements- implementation of the measures applying the specifications prescr

18、ibed by the individual specialist areas.Prerequisites for personnel:System audits and quality audits are to be implemented by persons independent of the sectors being audited. The audit team must be assembled in accordance with the task formulation and the respective scope of the audit. Each member

19、of the team must possess the relevant qualifications, whereby they have demonstrated sufficient knowledge and have undergone thorough instruction regarding the auditing tasks assigned to them.Documentation (audit report):In conclusion of the inspection, an audit report must be compiled which clearly

20、 defines the actual status as a result. Information, observations and deviations are to be allocated in accordance with the severity of the objection and cause, taking the respective standard into consideration.A deadline for the rectification of each individual objection, as well as the position re

21、sponsible for this rectification, must be specified. The deadline for the subsequent audit, for which the corrective measures are to be implemented, is to be declared. It is imperative that the audit reports are then submitted to the management.Other applicable documentation:Quality audits are to be

22、 implemented on the basis of procedural instruction QSA 217-1,Internal quality audits, which regulates the particulars and refers to the relevant standards (ISO 19011). 8.2.3 Monitoring and measuring processesMeasuring and monitoring of processes relates to the business processes (processes and proc

23、edures such as sales, development, planning, order processing), as well as production processes.To gauge efficiency of the QM system, measured parameters are defined for important business processes in the affiliated procedural instructions. The persons responsible for the respective processes are a

24、lso responsible for generation and evaluation of the data, as well as for reporting the key figures ascertained. The persons responsible for the processes are designated in the organisation plan. The key figures are reported in the intervals prescribed by the management and are relayed for managemen

25、t evaluation.The respective persons responsible for the processes are also responsible for continuous evaluation and improvement of the relevant processes. Improvement measures are documented.Further need for improvement is defined within the course of management evaluation based on the existing act

26、ual data and planning data. If necessary, temporary project teams are appointed for the implementation of improvement measures. (see chapter 5.6 Management evaluation)Measurements for production processes can relate to process parameters which are monitored to ensure conformity of the products (e.g.

27、 temperature, pressure etc.). These measurements are defined during the course of process planning and development. Measurements for monitoring of production efficiency are defined in QSA 207-1 Query, offer and order processing“.8.2.4 Monitoring and measuring of the productA fixed procedure for the

28、planning and implementation of quality inspections during the product development phases ensure that deviations in stipulated requirements are ascertained at an early stage at the point of origin, that errors can be rectified with minimum expenditure and corrective measures implemented.Scope of vali

29、dityThe scope of validity covers all purchased materials and products, all product development phases and the start-up and utilisation phase.Definition of termsSelf-inspection: Stage of the quality inspection necessary for quality control carried out by the operators themselvesIntermediate inspectio

30、n: Quality inspections during the realisation of a unitFinal inspection: Last of the quality inspections prior to handover of the unit to the receiverReceiving inspection: Approval inspection of a delivered productQuality inspection: Ascertainment of the degree to which a unit fulfils the quality re

31、quirementsCrane inspection: Inspections in compliance with trade association directives BGV D6 Cranes. ProcedureReceiving inspectionThe delivery of externally-manufactured parts is resulted in the received goods department.If a delivery is not subject to inspection (Skiplot), the delivery can be sto

32、red appropriately or transferred directly to its place of use in production or assembly.The definitions for the receiving inspection are specified in accordance with QSA206-3 and QSA241ff. Dynamic sampling and regularity of sample testing (attributive or variables inspection) can be obtained from here.Deliveries which have passed the receiving inspections are indicated on the delivery note w