Quality Assurance to ISO 9000 series. Normal Route With No QA System. Categor y. Serial Production. A Internal production control

Transcription

1 The directive lists 13 different mdules that define the inspectin requirements f bth the manufacturer and ntified bdy. Tw mdules, & 1, cver design nly and have t be used in cnjunctin with anther mdule cvering manufacture. Mdules H,H1 & G cver bth design and manufacture. The remaining mdules cver manufacture nly. The permitted cmbinatins and usage f these mdules is described belw. Categr y I II III Nrmal Rute With N QA System Serial Prductin A1 Internal prductin cntrl with mnitring f final assessment C1 Mnitring f final assessment Unit Prductin Serial Prductin A Internal prductin cntrl 1 examinatin F Prduct verificatin Quality Assurance t ISO 9000 series Unit Prductin D1 Or E1 D1 (QA T ISO 9002) Or E1 (QA T ISO 9003) Quality assurance fr prductin, final inspectin and testing E QA (ISO 9003) fr final 1 examinatin D QA ( ISO 9002) fr Prductin and Test

2 inspectin & testing Or H QA fr and Prductin (ISO 9001) IV F Prduct verificatin G examinatin and Inspectin during manufacture & testing D QA (ISO 9002) fr final inspectin, testing & manufacture H1 Full QA with design examinatin and mnitring f final assessment. This is nt quite as cmplicated as it may appear because all the mdules are variatins f mdule A and exist mainly t define the invlvement f the Ntified dy. Mdule A Prepare Technical Dcumentatin cvering design, manufacture and peratin. Ensure manufacture cnfrms with technical dcumentatin CE mark Draw up declaratin f cnfrmity Retain all dcuments fr 10 years The technical dcumentatin shuld address the essential safety requirements in sectin ne and tw f the directive. It shuld include:- Descriptin f the equipment The purpse f the equipment Operating pressure and temperature Hazard analysis Cntents:- liquid/gas txic/flammable/reactive crrsive/ersive

3 Flw rates and heat transfer rates if applicable Supprt structure and impsed ladings such as wind and snw/ice Fatigue / vibratin, Varying pressure, thermal cycling, differential expansin and manufacturing drawings drawings shuld cntain sufficient infrmatin t perfrm a full design assessment and supprting calculatins. Manufacturing drawings shuld cntain methd f manufacture and all relevant dimensins and tlerances. Instructins t explain the design, peratin and maintenance f the equipment. They shuld cver:- Intended use Fluid quality and maximum impurity levels if relevant Avidance f dangers such as cntact with ht surfaces. Safety devices required their flw rate and set pressure Maintenance/Inspectin requirements Cnnectin requirements Harmnised standards used r justificatin f the design Material appraisal : list all materials used stating why they are suitable and that they satisfy the directive. A list f the ESR's including a brief statement against the nes that are relevant stating hw they have been addressed Calculatin A full set f calculatin shuld be perfrmed t prve that the design f the vessel is adequate t withstand the design cnditins. Test Reprts Material certificates Internal inspectin reprts cvering at least the hydraulic test NDT reprts Quality plans, Prcedures cvering:- manufacturing, NDT, Welding etc, as applicable. Nte If yu are making a pressure vessel and dn't knw what it will cntain r yu

4 dn't knw if the material being specified t make the vessel is suitable, then yu shuld make this pint clear in the technical dcumentatin. Ideally yu shuld get a written statement frm the end user stating that the materials specified are suitable fr the item being manufactured. Mdule A1 (Inspectin Categry 2) This is the same as mdule A except:- Ntified bdy is required t mnitr final hydraulic test and examinatin. Welding prcedures and welder apprval tests must be witnessed by a ntified bdy r third party rganizatin apprved under the directive. The standards used d nt have t be EN288 and EN287, they can be any standard cnsidered apprpriate by the Ntified dy. Mdule (Inspectin Categry 3 and 4) This mdule cnsiders technical dcumentatin nly and has t be used in cnjunctin with a mdule cvering manufacture such as D, E F and C1. It is split int tw mdules:- 1 Cvers the technical dcumentatin fr singularly manufactured units. Any change t the design dcumentatin has t be re-apprved by the Ntified dy. Cvers serially manufactured units and permits sme variatin in design withut requiring re-apprval subject t the discretin f the Ntified dy, r as permitted by a harmnized standard. In additin t apprving the technical dcumentatin the Ntified dy has t apprve welding prcedures, welders and NDT persnnel, r check they have been apprved. Mdule C1 (Categry 3) This mdule can nly be used in cnjunctin with mdule, serially prduced items, nt 1, and there is n C. Mdule C1 is basically the same as A1 with the parts cvered by taken ut. Mdule F (Categry 3/4) This mdule like C1 must be used with either r 1. If the items are serially prduced then this mdule can be used in categry 4, but if they are

5 manufactured as single items nly categry 3. it is similar t A1 except the Ntified dy must:- Verify qualificatins f welding and NDT persnnel already apprved under mdule. Verify material certificates Check safety devices, if applicable. Mdule G (Categry 4) This mdule is fr single items nly. its the same as 1 and F except the Ntified bdy perfrms inspectins at varius stages f manufacture as they cnsider apprpriate r as dictated by a harmnized standard. Its the mst ppular mdule being used s far and can be applied t any categry. QA Mdules If yu have an accredited QA system t ne f the ISO 9000 standards then the Ntified dy audits yur system every 3 years and pays unexpected visits as it cnsiders apprpriate. D1 is the QA versin f A1 fr categry 2. (ISO 9002.) D is similar t D1 but has t be used in cnjunctin with either r 1. If yu are serially manufacturing items yu can use this mdule fr categry 4, but nly categry 3 fr single items. E requires QA fr final inspectin and test. (ISO 9003.) H and H1 are full QA cvering bth design and manufacture. (ISO 9001.)