Information
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DESIGN AND DEVELOPMENT
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Conducted on
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Prepared by
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Location
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Auditee
- Clause 7 - Documented information
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7.5.1 - Whether documents are adequate?
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7.5.2 - Whether formats and media appropriate?
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7.5.2 - Whether documents are reviewed for any changes with users & updated necessary changes & re-approved?
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7.5.2 - Whether Documents have change details and current revision status?
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7.5.3.1 - Whether Latest documents are avl at point of use?
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7.5.3.1 - Whether documents are adequately protected where required (e.g. from loss of confidentiality,improper use, or loss of integrity) ?
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7.5.3.2 - Whether Documents Distribution,storage,preservation,retention and disposal adreesed and followed?
Clause 6 - Risk and Opportunities
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6.1.2 - Are risks and opportunities identified for the department?
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6.1.2 - Is actions identified and part of quality management<br>system?
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6.1.2 - Is effectiveness of action evaluated ?
8.2 - New Enquiries
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8.2.3 - Is Input details available? (Enquiry mail, whatsapp communications........)
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8.2.3 - Is input details completee including purpose and target time? In case of clarification it raised with marketing?
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8.2 - Feasibility Study
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8.2.3 - Is a team feasibility study available?
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8.2.3 - Is the Costing sheet, Costing verification sheet & Budget<br>available?
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8.2.3 - Is costing sheet approved by top management ?
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8.2.3 - Is status of new enquiries reviewed internally and also with<br>marketing ?
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8.2.3 - Is status of new enquiries updated to top management ?
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8.3.2 - DESIGN AND DEVELOPMENT PLANNING
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8.3.2 - Is Master Plan Sheet and Development Activity Chart available ?
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8.3.2 - Does Plan cover all stages including design and development reviews,verification and validation?
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8.3.2 - Is responsibilities and authorities defined ?
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8.3.2 - Is new tools,jigs,fixtures,instruments,Machines required identified ? Is it communicated to the concerned ?
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8.3.2 - Is need for new suppliers identified ? Is it communicated to the concerned ?
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8.3.2 - Is there a plan for these internal and external resources ?
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8.3.2 - Is there any approval requirements and is it reflected in plan ?
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8.3.2 - Is need for any customer involvement identified and communicated to the concerned ?
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8.3.2 - Is level of control expected for the design and development process by customers defined ?
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8.3.2 - Is Quality,Cost,Delivery (QCD) targets fixed ?
8.3.3 - DESIGN AND DEVELOPMENT INPUTS
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8.3.3 - Is functional and performance requirement considered ?
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8.3.3 - Is inputs taken from similar products/ customer suggetions/lessons learnt taken ?
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8.3.3 - Is applicable standards or codes of practice considered ?
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8.3.3 - Is there any conflicting input ?If so is it resolved ?
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8.3.3 - Is DFMEA done when specified by customer or as specified by Nutech ?
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8.3.3 - Is input adequate, complete and clear ?
8.3.4 - DESIGN AND DEVELOPMENT CONTROLS
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8.3.4 - Are reviews conducted as per plan?
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8.3.4 - Are reviews conducted to verify ability to meet requirement?
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8.3.4 - Is verification activities conducted to ensure output meet the input requirements?
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8.3.4 - Is validation activities conducted to ensure that the resulting product meet the requirements ?
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8.3.4 - Are necessary actions are taken on problems determined during the reviews, or verification and validation activities ?
8.3.5 - DESIGN AND DEVELOPMENT OUTPUTS
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8.3.5 - Is output documents like Drawings,PFD,PFMEA,QCP,Work instruction, Packing specification available ?
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8.3.5 - Does design output documents meet the input requirements ?
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8.3.5 - Does output documents reflect Process/product characteristics,Measurement requirements, reference documents,acceptance criteria ?
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8.3.5 - Is training needs identified for new machine,product or process ? Is on-job training provided ?
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8.3.5 - Does output specify Special characterstics ?
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8.3.5 - Are output documents reviewed,verified and approved ?
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8.3.5 - Is proto approval done where specified by customer ?
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8.3.5 - Is output documents like Drawings,PFD,PFMEA,QCP,Work instruction, Packing specification updated for changes ?
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8.3.5 - Is operator re-training given where required ?
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8.3.5 - Is MSA /SPC done when specified by customer or by<br>Nutech ?
8.3.5 - PPAP
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8.3.5 - Is trial Run done as per PPAP when required ?
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8.3.5 - Is MSA & SPC studies conductivities ?
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8.3.5 - Is Validation done for process parameters ?
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8.3.5 - Is product validated as directed by customer ?
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8.3.5 - Is packing methodology Evaluated & Validated ?
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8.3.5 - Is PPAP samples along with documents submitted to customer ?
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8.3.5 - Is Quality Planning sign off done before start to regular production ?
8.3.6 - Design and development changes
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8.3.6 - Is action taken on add and change note request ?
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8.3.6 - Is Feasibile to change reviewed ?
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8.3.6 - Is the effect on characteristics of the products or production activities reviewed ?
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8.3.6 - Is availability and use of suitable monitoring and measuring resources verifed ?
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8.3.6 - Is add and change request review details avilable ?
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8.3.6 - Is action identified during review approved by authorized persons ?
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8.3.6 - Is action taken on add and change note ?
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8.3.6 - Is impact of change on risk reviewed ? (PFMEA…)
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8.3.6 - Is standadisation as per add and change adequate and completed ?
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8.3.6 - (For customer /Supplier requests) Is commercial, master, design, tool & timing chart reviewed ?
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8.3.6 - (For customer /Supplier requests) Is acknowledgement done with commercial & technical feasibility ,study report & planning (Timing plan)
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8.3.6 - Incorporate changes in the corresponding system & documents including PFD, PFMEA, CP, work instruction, packing standard ?
10.3 Continual Improvement
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"10.3 - Is there any continual improvement project is identified for the department (Kaizen,VAVE…)?"
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10.3 - Is action taken for completing continual improvement projects as per plan ?
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10.3 - Is action taken for NCR during 5S audit ?
9.2.2 - AUDITS
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9.2.2 - Are corrective actions taken for NCR raised during Internal audit ?
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9.2.2 - Are corrective actions effective so that it is not repeated ?
