ISO 9000_2001 - Do Your Quality Objectives Deliver Real Results

8/14/2019 ISO 9000_2001 - Do Your Quality Objectives Deliver Real Results

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d0\green128\blue0;}{\stylesheet{\s0\f0\fs24\cf0\sbasedon222\snext0\ql Default;}{\s1\stextflow0\sbasedon0\snext0 Normal (Web);}{\s2\stextflow0\sbasedon0\snext0Normal;}{\s3\stextflow0\sbasedon0\snext0 Comment Text;}{\s4\stextflow0\sbasedon0\snext0 bluetrue;}{\s5\stextflow0\sbasedon0\snext0bluebld;}}{\*\generator Adobe Acrobat Exchange-Pro 9.0.0}{\info{\title ISO 9000:2001 - DoYour Quality Objectives Deliver Real Results}{\author Support}{\creatim\yr2010\mo1\dy29\hr18\min9\sec35}{\revtim\yr2010\mo1\dy29\hr18\min9\sec35}{\id1305812}}\pard\plain\ql\f0\fs24\cf0\paperh16840\paperw11904\margt878\margb1242\margr604\margl900\pghsxn17340\pgwsxn11904\margtsxn1378\margbsxn1242\margrsxn604\marglsxn900\par\'20\pard\pard\s1\sa100\sb100\fi0\ri0\li0\qc\stextflow0\b\cf1\fs48 ISO 9000:\b0\cf0{\ul\b\cf1\fs48

200\b0\b\fs48\f15\b0}\ulnone\strike0\b\cf1\fs48 - Are You Auditing 21st CenturyRequirements?\b0\cf0\fs48\f2\ulnone\strike0\par\pard\s1\sa100\sb100\fi0\ri0\li0\qj\stextflow0\fs22\f3\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf2\fs22Introduction\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4 In myopinion, auditing often appears to be an end in itself\b0\fs22\f3 . \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22 The roleappears to be one whereby the auditor is there to verify that the procedure isbeing followed rather than trying to determine whether the activity is beingperformed in a way that is beneficial to the organisation and, as a by-product,

that it meets the procedure.\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22This was particularly the case for ISO 9001:1994 internal audits. They were oftenperformed in a robotic way, where the auditor followed a pre-defined checklistwhich was designed to ask a question against each paragraph, just to put "a tickin the box".\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf2\fs22What's New?\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4Audits should now assess the effectiveness of the QMS and an organisation'soverall performance\b0\fs22\f3 .\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22 ISO

9001:2008 Para 8.2.2 now requires that your internal audits demonstrate compliancewith your "planned arrangements" (eg quality manual, procedures or process-maps)\b\fs22\f4 and\b0\fs22\f3 ISO 9001. You must also audit these wider issues toensure compliance to the Standard. Clearly, internal auditors must now have anunderstanding of ISO 9001:2008.\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22An audit of your key quality management activities will always be more relevantand produce more meaningful results than a simple procedural audit. Most of thefollowing high-level questions can also used to supplement your own checklists aspart of your routine internal audits. You may well want to refine this list basedon special concerns and risks faced by your company. Decide what matters most to


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your organisation and focus your audit process on those aspects.\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf2\fs22What are the Most Powerful Audit Questions? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22 Here's mypersonal Top \fs22 Ten, plus lots of supplementary questions.\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4 Thefirst 9 questions are the main points that Certification Body auditors now focus

on\b0\fs22\f3 .\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22It is important for internal auditors to ask these high-level questions (ratherthan merely focusing on procedures as was usually the case under ISO 9001:1994)\b\fs22\f4 especially in the run up to Certification \b0\fs22\f3 and periodicallythereafter. \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22 MostCertification Bodies require at least three months history between theimplementation of the quality system and the Certification Audit. Typically, theyrequire that at least one internal audit covering\b\fs22\f4 all elements\b0\fs22\f3 of the quality system has been completed andfollowed by a management review before the Certification Audit. This enables thecompany to identify any problems for itself and to resolve them prior to

assessment by the Certification Body.\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4Question 10 deals with the new issues of auditing processes and auditing withoutprocedures.\b0\cf0\fs22\f3\ulnone\strike0\par\pard\pagebb\sa100\sb100\fi0\ri0\li0\qj\stextflow0\fs22\ulnone\strike0\par\pard\s1\sa100\sb100\fi0\ri0\li0\ql\stextflow0\cf1\fs22 Best

Regards,\b\fs22\f4 \b0\cf0\fs22\f3\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\ql\stextflow0\i\cf3\fs22\f5Stephanie Keen\i0\cf0\fs22\f3\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\ql\stextflow0\cf1\fs22Stephanie Keen\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\ql\stextflow0\cf1\fs22 Managing

Partner \b\fs22\f4{\ul ISO Navigator ManagementSystems }\b0\ulnone\strike0\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\ql\stextflow0\fs22\f3 E-mail\b\cf0\fs22\f4 \b0{\field{\*\fldinst {HYPERLINK "mailto:[email protected]?subject=More%20information%20please%20%28IA%29"}}{\fldrslt {\b\cf3\fs22{\[email protected]}\b0\ulnone\strike0}}}\b\fs22 \b0\fs22\f3\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\ql\stextflow0\cf1\fs22Web\b\cf0\fs22\f4 \b0{\field{\*\fldinst {HYPERLINK"http://www.iso9001help.co.uk/"}}{\fldrslt {\b\cf3\fs22{\ulhttp://www.iso9001help.co.uk}\b0\ulnone\strike0}}}\b\fs22 \b0\fs22\f3\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\ql\stextflow0\b\i\cf2\fs22\f6p.s.\b0\i0\b\cf0\fs22\f4 \b0{\field{\*\fldinst {HYPERLINK"http://www.iso9001help.co.uk/ISO_9001_quality_manual.htm"}}{\fldrslt

{\b\cf3\fs22{\ul click here}\b0\ulnone\strike0}}}\b\fs22 \b0\cf1\fs22\f3 toOrder\b\fs22\f4 QM 9001\b0\cf0\fs22\f3\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\ql\stextflow0\b\i\cf2\fs22\f6p.p.s\b0\i0\b\i\cf4\fs22 .\b0\i0\b\cf1\fs22\f4 \b0{\field{\*\fldinst {HYPERLINK"mailto:[email protected]?subject=ISONavigator%20Attachments%20Please%20%28IA%29"}}{\fldrslt {\b\cf3\fs22{\ul e-mail}\b0\ulnone\strike0}}}\cf1\fs22\f3 for ourISO 9000 tips\cf0\fs22 \ulnone\strike0\par{\shp{\*\shpinst\shpleft932\shptop5768\shpright10278\shpbottom6132\shpfhdr0\shpbxpage\shpbypage\shpwr5\shpwrk0\shpfblwtxt1{\sp{\sn shapeType}{\sv 202}}{\sp{\sn fLine}{\sv 0}}{\sp{\sn fFilled}{\sv 0}}


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{\shptxt\trowd\irow0\irowband0\lastrow\trgaph108\trrh152\trleft72\trbrdrt\brdrnil\trbrdrb\brdrnil\trbrdrl\brdrnil\trbrdrr\brdrnil\clvertalt\clbrdrt\brdrnil\clbrdrb\brdrnil\clbrdrl\brdrnil\clbrdrr\brdrnil\cltxlrtb\clftsWidth1\clshdrawnil\cellx9570\pard\plain\intbl\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf4\fs22\f4Customer satisfaction - how useful was this paper? Please give ussome\b0\cf4\fs22\f3 {\field{\*\fldinst {HYPERLINK "mailto:[email protected]?subject=Feedback%20on%20Audit%20Questions"}}{\fldrslt {\cf3\fs22\f3{\ulfeedback}\ulnone\strike0}}}\ulnone\strike0\cell {\pard\plain\intbl}

{\trowd\irow0\irowband0\lastrow\trgaph108\trrh152\trleft72\trbrdrt\brdrnil\trbrdrb\brdrnil\trbrdrl\brdrnil\trbrdrr\brdrnil\clvertalt\clbrdrt\brdrnil\clbrdrb\brdrnil\clbrdrl\brdrnil\clbrdrr\brdrnil\cltxlrtb\clftsWidth1\clshdrawnil\cellx9570\row}}}}\pard\plain\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf2\fs22 1. Arepersonnel aware of quality policy & quality objectives?\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22ISO 9001:2008 requires that organisations establish measurable objectives atrelevant functions and levels (Para. 5.4.1) and that the quality policy iscommunicated and understood (Para. 5.3 d)\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22Perhaps an even more significant requirement is that personnel understand how they

contribute to achieving these objectives (Para. 6.2.2). \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4These requirements don't just apply to SOME employees; they apply toEVERYONE.\b0\fs22\f3 \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22 Allpersonnel must be able to explain how they help achieve objectives.\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22 Not allobjectives apply to everyone. Auditors can only expect that personnel understandthe quality objectives that apply to them. Interviews with personnel allow theauditor to verify if they have appropriate awareness, understanding and knowledgeof the way the organisation\rquote s quality policy and objectives relate to theirown activity,\b\fs22\f4 regardless of the terms used to express their

understanding\b0\fs22\f3 .\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22 Thisquestion directly reflects on an organisation's ability to communicate whatmatters most to its success. Truly comprehending objectives means that peopleunderstand specifically what they can do to improve the organisation. Theyappreciate the significance of their roles and are prepared to carry them out.This knowledge creates strategic focus throughout the organisation. Instead ofhaving a limited view of activities and tasks, personnel begin to understand howtheir jobs link to the organisation's larger mission.\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22Auditors should keep in mind that the objectives can be measured in a quantitative(eg \b\fs22\f4 hard numbers:\b0\fs22\f3 counts or physical measurements) orqualitative manner (eg

\b\fs22\f4 soft numbers: \b0\fs22\f3 surveys, opinions, etc). \b\fs22\f4 Qualityobjectives are not static\b0\fs22\f3 and need to be updated in the light of thecurrent business climate and the quest for continual improvement. Also rememberthat there is a clear link\fs22 between the dynamic aspect of revising the quality policy and the qualityobjectives and the commitment of the organisation to continualimprovement.\cf0\fs22\ulnone\strike0\par\pard\pagebb\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4 When auditing objectives remember that you are looking at a work-in-progress andare unlikely to see the final result\b0\fs22\f3 .\cf0\fs22


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\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4 Forexample\b0\fs22\f3 : The objective is to reduce scrap by 5% over a 12 month periodand the audit is carried out at the start of Month Four.\cf0\fs22\ulnone\strike0\par{\shp{\*\shpinst\shpleft1415\shptop3065\shpright9367\shpbottom3752\shpfhdr0\shpbxpage\shpbypage\shpwr5\shpwrk0\shpfblwtxt1{\sp{\sn shapeType}{\sv 202}}{\sp{\sn fLine}{\sv 0}}{\sp{\sn fFilled}{\sv 0}}{\shptxt\trowd\irow0\irowband0\trgaph108\trrh152\trleft72\trbrdrt\brdrnil\trbrdrb\

brdrnil\trbrdrl\brdrnil\trbrdrr\brdrnil\clvertalt\clbrdrt\brdrnil\clbrdrb\brdrnil\clbrdrl\brdrnil\clbrdrr\brdrnil\cltxlrtb\clftsWidth1\clcbpat5\cellx3295\clvertalt\clbrdrt\brdrnil\clbrdrb\brdrnil\clbrdrl\brdrnil\clbrdrr\brdrnil\cltxlrtb\clftsWidth1\clcbpat5\cellx5083\clvertalt\clbrdrt\brdrnil\clbrdrb\brdrnil\clbrdrl\brdrnil\clbrdrr\brdrnil\cltxlrtb\clftsWidth1\clcbpat5\cellx6871\clvertalt\clbrdrt\brdrnil\clbrdrb\brdrnil\clbrdrl\brdrnil\clbrdrr\brdrnil\cltxlrtb\clftsWidth1\clcbpat5\cellx8659\pard\plain\intbl\s2\sa0\sb0\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4Month\b0\cf0\fs22\f3 \b0\i0\cell{\pard\plain\intbl}\pard\plain\intbl\sa0\sb0\fi0\ri0\li0\qj\stextflow0\cf1\fs22\f3One\cf0\fs22\f3 \ulnone\strike0\cell{\pard\plain\intbl}\pard\plain\intbl\sa0\sb0\fi0\ri0\li0\qj\stextflow0\cf1\fs22\f3Two\cf0\fs22\f3\ulnone\strike0\cell

{\pard\plain\intbl}\pard\plain\intbl\sa0\sb0\fi0\ri0\li0\qj\stextflow0\cf1\fs22\f3Three\cf0\fs22\f3 \ulnone\strike0\cell {\pard\plain\intbl}{\trowd\irow0\irowband0\trgaph108\trrh152\trleft72\trbrdrt\brdrnil\trbrdrb\brdrnil\trbrdrl\brdrnil\trbrdrr\brdrnil\clvertalt\clbrdrt\brdrnil\clbrdrb\brdrnil\clbrdrl\brdrnil\clbrdrr\brdrnil\cltxlrtb\clftsWidth1\clcbpat5\cellx3295\clvertalt\clbrdrt\brdrnil\clbrdrb\brdrnil\clbrdrl\brdrnil\clbrdrr\brdrnil\cltxlrtb\clftsWidth1\clcbpat5\cellx5083\clvertalt\clbrdrt\brdrnil\clbrdrb\brdrnil\clbrdrl\brdrnil\clbrdrr\brdrnil\cltxlrtb\clftsWidth1\clcbpat5\cellx6871\clvertalt\clbrdrt\brdrnil\clbrdrb\brdrnil\clbrdrl\brdrnil\clbrdrr\brdrnil\cltxlrtb\clftsWidth1\clcbpat5\cellx8659\row}\trowd\irow1\irowband1\lastrow\trgaph108\trrh152\trleft72\trbrdrt\brdrnil\trbrdrb\brdrnil\trbrdrl\brdrnil\trbrdrr\brdrnil\clvertalt\clbrdrt\brdrnil\clbrdrb\brdrnil\clbrdrl\brdrnil\clbrdrr\brdrnil\cltxlrtb\clftsWidth1\clcbpat5\cellx3295\clvertalt\clbrdrt\brdrnil\clbrdrb\brdrnil\clbrdrl\brdrnil\clbrdrr\brdrnil\cltxlrtb\clftsWid

th1\clcbpat5\cellx5083\clvertalt\clbrdrt\brdrnil\clbrdrb\brdrnil\clbrdrl\brdrnil\clbrdrr\brdrnil\cltxlrtb\clftsWidth1\clcbpat5\cellx6871\clvertalt\clbrdrt\brdrnil\clbrdrb\brdrnil\clbrdrl\brdrnil\clbrdrr\brdrnil\cltxlrtb\clftsWidth1\clcbpat5\cellx8659\pard\plain\intbl\sa0\sb0\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4% Improvement\b0\cf0\fs22\f3 \ulnone\strike0\cell{\pard\plain\intbl}\pard\plain\intbl\sa0\sb0\fi0\ri0\li0\qj\stextflow0\cf1\fs22\f30.1\cf0\fs22\f3 \ulnone\strike0\cell{\pard\plain\intbl}\pard\plain\intbl\sa0\sb0\fi0\ri0\li0\qj\stextflow0\cf1\fs22\f3

0.4\cf0\fs22\f3 \ulnone\strike0\cell{\pard\plain\intbl}\pard\plain\intbl\sa0\sb0\fi0\ri0\li0\qj\stextflow0\cf1\fs22\f30.7\cf0\fs22\f3 \ulnone\strike0\cell {\pard\plain\intbl}{\trowd\irow1\irowband1\lastrow\trgaph108\trrh152\trleft72\trbrdrt\brdrnil\trbrdrb

\brdrnil\trbrdrl\brdrnil\trbrdrr\brdrnil\clvertalt\clbrdrt\brdrnil\clbrdrb\brdrnil\clbrdrl\brdrnil\clbrdrr\brdrnil\cltxlrtb\clftsWidth1\clcbpat5\cellx3295\clvertalt\clbrdrt\brdrnil\clbrdrb\brdrnil\clbrdrl\brdrnil\clbrdrr\brdrnil\cltxlrtb\clftsWidth1\clcbpat5\cellx5083\clvertalt\clbrdrt\brdrnil\clbrdrb\brdrnil\clbrdrl\brdrnil\clbrdrr\brdrnil\cltxlrtb\clftsWidth1\clcbpat5\cellx6871\clvertalt\clbrdrt\brdrnil\clbrdrb\brdrnil\clbrdrl\brdrnil\clbrdrr\brdrnil\cltxlrtb\clftsWidth1\clcbpat5\cellx8659\row}}}}\pard\plain\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4TOTAL\b0\fs22\f3 1.2% improvement overall.\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\ql\stextflow0\cf1\fs22 Would yousay: a) they are on target? b) they are behind schedule? c) they've made a


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good (but slow) start? d) any improvement is better than none?\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22Old style auditors would immediately say \b\fs22\f4 b)\b0\fs22\f3 and reach forthe non-conformance report and de-motivate\fs22\f7 e\fs22\f3 veryone. I'd say\b\fs22\f4c)\b0\fs22\f3 and want some assurance that following a slow start the trend willcontinue and that Month Three is not a freak.\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf2\fs22\f4

Closely related questions include:\b0\fs22\f3\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 How are objectives determined? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95\b0\fs22\f3 How are employees made aware of policy & objectives? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 How is progress towards objectives measured andcommunicated? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95\b0\fs22\f3 What processes and/or tools are in place tohelp achieve objectives? \cf0\fs22

\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 Is there evidence of progress? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\ql\stextflow0\cf1\fs22 Do YourQuality Objectives Deliver Real Results? {\field{\*\fldinst {HYPERLINK"mailto:[email protected]?subject=Objectives%20Tips%20%28HTML%20Attachment%28IA%29%29%20Please"}}{\fldrslt {\cf3\fs22{\ul e-mail}\ulnone\strike0}}}\cf1\fs22 for our Tips on Quality Objectives (HTMLattachment approx 45Kb)\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf2\fs222. What happens to nonconforming product?\cf4\fs22 \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22 Thisquestion reflects on the organisation's ability to deal with product problems in a

systematic way. Controlling nonconforming products is a basic discipline (Para.8.3) and one that smart auditors always probe. The answer to this question can becompared to the documented procedure and, more importantly, to the auditor'sobservations.\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4 Fewother processes require as rigid adherence to procedures as controllingnonconforming products.\b0\fs22\f3 There can be no room for deviation. \cf0\fs22\ulnone\strike0\par\pard\pagebb\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22It's worth mentioning that controlling nonconforming products applies to servicesjust as much as it does to tangible goods. Reports, data, test results andintellectual property, to name just a few service outputs, can all be potentiallynonconforming, in which case all the disciplines of this process apply.

\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22Problems relating to controlling nonconforming products almost always posesignificant risks to the organisation eg additional costs, wasted time, aggravatedemployees, angry customers and loss of business.\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22During an audit, find some examples of nonconforming products (if there areany) \b\cf2\fs22\f4 and follow-up with these questions: \b0\cf0\fs22\f3\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 How are nonconforming products identified?\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95\b0\fs22\f3 Where are they located? \cf0\fs22


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\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95\b0\fs22\f3 What are the responsibilities and authoritiesrelated to dealing with nonconforming products? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95\b0\fs22\f3 How is disposal determined and implemented?\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95\b0\fs22\f3 Where are the records of nonconforming productsand actions taken on them? \cf0\fs22

\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95\b0\fs22\f3 Are there trends in nonconforming products andwhat's being done about it? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95\b0\fs22\f3 How is the procedure linked to the correctiveaction process?\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22It's worth mentioning that controlling nonconforming products applies toservices\cf6\fs22 \cf1\fs22 and software just as much as it does to tangiblegoods. Reports, data, test results and intellectual property, to name just a fewservice outputs, can all be potentially nonconforming, in which case all thedisciplines of this process apply.\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\fs22

\cf2\fs22 3. How are customer requirements assessed andcommunicated?\b\cf1\fs22\f4 \b0\cf0\fs22\f3\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22 Allorganisations have a "product". It might go to an external customer or simply tothe next process inside the organisation. In all cases, though, personnel mustunderstand the product requirements. ISO 9001:2008 Para. 7.2 specifically requiresthat organisations identify product requirements in four ways:\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 As stated by the customer \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3Unstated by the customer but necessary for intended use \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22

\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 As statutory and legal regulations related tothe product \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 As any additional requirements determined bythe organisation \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22 Thestandard additionally requires that information describing the product beavailable (ie, documented).\b\fs22\f4 Asking how personnel access product requirements is an important auditquestion because when requirements aren't accessible, big problems oftenresult\b0\fs22\f3 . Employees don't need to know product requirements by heart,but they should certainly be able to find the current versions of requirements anddescribe how they carry them out.

\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf2\fs22\f4Follow up questions could include: \b0\cf0\fs22\f3\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95\b0\fs22\f3 Are product requirements complete?\cf0\fs22\ulnone\strike0\par\pard\pagebb\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 How does the organisation ensure that only thecorrect versions are available? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95\b0\fs22\f3 How are requirements reviewed prior to


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acceptance? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95\b0\fs22\f3 How do you ensure that product meets the statedrequirements?\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 What happens when changes are made to productrequirements? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\fs22

\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf2\fs22 4. Howare problems prevented? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22 Problemcorrection is relatively simple: Define the problem, identify the cause and takeaction to remove it.\b\fs22\f4 Problem prevention is rather more complex\b0\fs22\f3 . Preventiveaction is specifically required by ISO 9001:2008 (Para. 8.5.3), and it providesone of the most valuable links to continual improvement. \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4The most obvious way to generate preventive action is by analyzing data (Para.8.4)\b0\fs22\f3 . Data analysis is a primary job of top management, but it canhappen at other levels of the organisation too. When an organisation openly sharesdata and encourages its analysis on a broad scale, then preventive action becomes

easy.\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22Employee creativity and innovation can also be a valuable starting point forpreventive action. Forward thinking organisations look for ways to solicitimprovement ideas from their employees and provide feedback on the viability ofthe ideas. Another source of preventive action is feedback from customers. Often,customers will provide ideas for improving the product in subtle yet significantways.\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf2\fs22\f4Additional questions could include:\b0\cf1\fs22\f3 \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95\b0\fs22\f3

How do data trends get analyzed? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 How do employees communicate their improvementideas? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 How do preventive actions get recorded?\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 Are statistical techniques (eg FMEA) used?\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22

\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 How are customer perceptions captured?\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 How are critical pieces of plant and equipment

maintained?\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 Is there a disaster recoveryprocedure?\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95\b0\fs22\f3 Is the work environment appropriate? (Ref Para 6.4)\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf2\fs22 5. How iscustomer satisfaction data collected and used?\b\fs22\f4 \b0\cf0\fs22\f3


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\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22 Thisquestion probably won't apply to all personnel. It's especially relevant to topmanagement and employees responsible for gauging customer perceptions.\b\fs22\f4 The question is significant because most organisations manage fairlywell to capture perceptions but usually fall short of actually doing somethingwith the information. \b0\cf0\fs22\f3\ulnone\strike0\par\pard\pagebb\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22ISO 9001:2008 (Para. 8.2.1) specifically requires that organisations define

methods for obtaining and using customer satisfaction data. \b\fs22\f4 Customerfeedback is a process. It needs to be audited as a process\b0\fs22\f3 , not asa \ldblquote clause of the standard\rdblquote . The audit also needs to beperformed on the way in which the process is managed (Para. 4.1.c), and itsability to provide meaningful information with which to judge the overalleffectiveness of the QMS.\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22The way in which the organisation obtains this feedback (\ldblquote themethod\rdblquote ) is up to the organisation to define. \b\fs22\f4 This is anotherreason for relying on simple methods for capturing customer perceptions:Experience suggests that the more complex and resource-intensive your customersatisfaction methods are, the less likely you'll take action on what you learn.\b0\fs22\f3 It's a curious paradox. Many organisations run out of gas before they

get to the action phase, and the valuable opportunities afforded by customerfeedback are ignored as other problems arise. \cf0\fs22\ulnone\strike0\par\pard\s3\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22The auditor should recognize that many factors can affect the organisation\rquotes approach, and that there is no fixed \ldblquote recipe\rdblquote . Considerationshould be given to factors such as:\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4\u8226 \'95\b0\fs22\f3 the organisation's size and complexity\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4\u8226 \'95 \b0\fs22\f3 the level of sophistication of products andcustomers\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4\u8226 \'95 \b0\fs22\f3 the risks associated with the product\cf0\fs22

\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4\u8226 \'95 \b0\fs22\f3 the diversity of the customer base\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf2\fs22\f4Here are some supplementary questions: \b0\cf0\fs22\f3\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4\u8226 \'95\b0\fs22\f3 How is customer satisfaction data analyzed? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95\b0\fs22\f3 How are opportunities identified, prioritisedand actioned? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 What's the connection to the corrective andpreventive action systems?\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22

\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 What are the organisation's long-term trends incustomer satisfaction? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 How are resources for customer satisfactionidentified and provided? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 What connections exist between customersatisfaction and the organisation's objectives?\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf2\fs22 6. How are


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customer complaints handled?\b\fs22\f4 \b0\cf0\fs22\f3\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22Despite everyone's best efforts, customers will occasionally complain. \b\fs22\f4Customer complaints represent both a huge risk and a valuable opportunity\b0\fs22\f3 to the organisation-it all depends on how they're handled. \b\fs22\f4This question is especially relevant to salespeople, customer servicerepresentatives, technical personnel and top management\b0\fs22\f3 . \cf0\fs22

\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22 Theauditor is looking for proof of a systematic approach to dealing with complaints.This will typically include defined responsibilities for logging and trackingcomplaints, clear problem statements with all relevant facts included,determination of problem causes and actions that address the causes. Specificexamples of complaints must be sampled, of course.\b\fs22\f4 The link between the complaint process and corrective action alsorequires special scrutiny \b0\fs22\f3 (Para. 8.5.2\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\fs22 ).\b\fs22\f4\b0\cf0\fs22\f3\ulnone\strike0\par\pard\pagebb\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf2\fs22\f4Here are some follow up questions: \b0\cf0\fs22\f3

\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 What's the largest complaint category?\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22

\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 What's being done about it? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 Has the number of complaints changed over time?\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22

\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 How are personnel trained in their roles inpreventing complaints? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 How are customers made aware of actions on

their complaints?\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 What tools are used to identify the causes ofcomplaints? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf2\fs22 7. How

does top management demonstrate commitment? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4 Anauditor with limited experience should NEVER be assigned to interview topmanagement\b0\cf0\fs22\f3\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4 Oneof top management's most important responsibilities is reviewing the

organisation's performance\b0\fs22\f3 . I'm not talking about employee performancebut the organisation's success as a whole.\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22Is our organisation becoming more efficient, more competitive, better at servingcustomers? Or is it moving in the opposite direction? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22Top management should regularly analyze the data that provide the answers to thesequestions. ISO 9001:2008 (Para. 5.6) specifically requires management review withdefined inputs and outputs. And there's no sense in conducting an ISO 9001management review, then conducting a separate review of the organisation'sperformance -


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\b\fs22\f4 they should be one and the same\b0\fs22\f3 . \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4 Someof the best approaches to reviewing organisational performance are the mostcreative\b0\fs22\f3 . Many organisations conduct their management reviews in anumber of different forums and time frames, which is a practical and realistic wayto approach the process. Regardless of how the review is conducted, the three keypoints are data analysis, identifying opportunities and taking action on them.Smart organisations treat these three activities as inseparable.

\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\ql\stextflow0\b\cf2\fs22\f4 Hereare some related questions: \b0\b\cf1\fs22 \u8226 \'95\b0\fs22\f3 re policies andobjectives available and relevant? \b\fs22\f4 \u8226 \'95\b0\fs22\f3 s there aclear link between the policies and objectives?\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 Who's involved in reviewing the organisation'sperformance? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 What actions have resulted from these reviews?\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 How are records of the reviews generated?\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4

\u8226 \'95 \b0\fs22\f3 Are all required inputs and outputs addressed byrecords? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 How does the rest of the organisation learn ofactions arising from reviews?\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\fs22\cf2\fs22 8. How is continual improvement demonstrated?\b\cf1\fs22\f4 \b0\fs22\f3(Para. 8.5.1)\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22This question can be asked of everyone, especially top management. \b\fs22\f4 Inorganisations that have developed improvement tools and provided opportunities fortheir application, this is an \b0\b\fs22 easy question. In organisations whereimprovement efforts are very narrowly applied, it becomes a much harder question

\b0\fs22\f3 . There should certainly be some evidence of continual improvementwithin the scope of most, if not all, audits. \cf0\fs22\ulnone\strike0\par\pard\pagebb\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22Large-scale improvements are impressive, of course,\b\fs22\f4 but all improvements have value\b0\fs22\f3 . This question actuallysummarizes many of the earlier questions into a single point of inquiry. Theultimate purpose of a management system is to provide a means for improvement.\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22

Just because one or two people aren't able to provide evidence of improvementisn't necessarily a problem. It may indicate weak improvement efforts, though, andfurther investigation would certainly be needed. In a mature QMS, all personnelare involved in making improvements, and proof of this happening is abundant.

\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22Look for evidence that the organisation is analysing data from process monitoring,and is then taking the results forward for evaluating process efficiency and/orimproving process output.\b\fs22\f4 One point that should be specifically examined,\b0\fs22\f3 is theconsistency of the way in which the improvement of any one process contributes tomeeting the overall objectives, so as to ensure that this will not conflict withthe achievement of other objectives.\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22The type of information that an auditor needs is evidence of how the companyobjectives are translated into specific QMS objectives. \b\fs22\f4 For


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example\b0\fs22\f3 : the organisation has set an objective to reduce customercomplains by 20%. Analysis shows that 50% of those complaints are because ofoverdue deliveries. The auditor should then look for evidence that theorganisation is monitoring and analysing key aspects of its scheduling andplanning activities to reduce delays.\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf2\fs22\f4 Theseare some additional points to investigate:\b0\fs22\f3 \cf0\fs22

\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95\b0\fs22\f3 Who's involved in improvement efforts? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95\b0\fs22\f3 What tools are used to pursue continualimprovement? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 How are personnel trained to use improvementtools? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 How are improvement ideas prioritized?\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22

\b\fs22\f4 \u8226 \'95\b0\fs22\f3 How are employees made aware of improvementefforts and successes? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf2\fs22 9. How

are training needs determined?\cf1\fs22 \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22 Developinghuman resources is one of the keys to organisational success (Para. 6.2). Thisaudit question attempts to probe the degree of planning that goes into developingthese resources.\b\fs22\f4 Is training performed as a knee-jerk activity with no realobjectives? \b0\fs22\f3 Or is it geared toward empowering each employee with theskills and knowledge needed to move the organisation forward?\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22

During the audit, make sure to probe the training needs that have been determinedfor all levels of personnel: hourly, salaried, contract, technicians, line-managers and top management. \b\fs22\f4 Training is an activity that applies toall personnel, not just a narrow slice of the organisation.\b0\cf0\fs22\f3\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22 Theauditor should determine whether there is a systematic approach in place toidentify skills and e competencies and to verify that the approach is effective.The outcome of the process may be a list, register, database, human resourcesplan, competencies development plan, contract, project or product plan, etc\cf0\fs22\ulnone\strike0\par\pard\pagebb\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22Verify that some form of evaluation process is in place to ensure that the

competencies are appropriate to the organisation's activities, and that thepersonnel are demonstrating those competencies.\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf2\fs22\f4 Hereare some additional questions:\b0\b\cf1\fs22 \b0\cf0\fs22\f3\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3What kind of training is given to new employees? (incl. those on short-termcontracts) \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 How are personnel made aware of the


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organisation's mission, values and measurable objectives?\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 How is the effectiveness of training evaluated?\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22\b\fs22\f4\u8226 \'95 \b0\fs22\f3 What happens when training is determined to have beenineffective? \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22

\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 What records of training are maintained?\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf2\fs22 10.Auditing processes & Auditing without procedures\cf0\fs22\ulnone\strike0\par\pard\s4\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22A significant new challenge for the auditor in ISO 9001:2008 is that there may beno documented procedure defining the process against which the audit is be carriedout. We know that there are only \b\fs22\f4 6 mandatory documentedprocedures\b0\fs22\f3 required and the organisation may have chosen analternative method of controlling the process.\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22If the alternative is a flowchart or process map there is still something tangible

to follow, but if there is no documentation and the process depends on a competentperson to control it, auditing is no longer straightforward.\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22Nonetheless, it can still be audited. Perhaps the principles behind this method ofauditing should be used to audit all processes, \b\fs22\f4 whether there is adocumented procedure or not\b0\fs22\f3 .\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf2\fs22 10 A -How to I audit a process?\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4 Ifyou have been involved in a certification body audit you have probably noticedthat the professional auditors often use this method to perform the audit\b0\fs22\f3 :\cf0\fs22

\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22 They willeither start at the beginning or end of the organisation's workflow and follow asample of orders, contracts, projects, products, etc. through the organisation.This is a process audit. On an internal audit you may not have time to do theentire process in one audit - in which case break the process into manageablechunks and use that as your audit schedule.\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22The first task for the auditor is to \b\fs22\f4 establish what the process isthere to achieve\b0\fs22\f3 . If it is a sales department, it could be that itsprimary function is to provide an effective interface between the organisation andits customers, and to enter clear, accurate customer orders onto the computersystem in a timely manner. (These may turn out to be the \lquote qualityobjectives' for that process as required by Para 5.4.1).

\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22If these are the most important objectives of that process, then the audit mustconcentrate on verifying whether or not they are being achieved. \cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22Performance is often best proven by looking at how well output of \b\fs22\f4Process A\b0\fs22\f3 satisfies the input requirements of \b\fs22\f4 ProcessB\b0\fs22\f3 . For example: how often does Process B have problems with the dataentered, how many customer complaints have arisen due to inaccurate or lateinformation being entered?\cf0\fs22\ulnone\strike0\par\pard\pagebb\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22 If


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there is a documented procedure in place it should define the process and thesteps to be taken to ensure that the objectives are achieved. \b\cf2\fs22\f4Consider these points:\b0\cf0\fs22\f3\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\ql\stextflow0\b\cf1\fs22\f4\u8226 \'95 \b0\fs22\f3 is there continuity between the various processes in theorganisation? \b\fs22\f4 \u8226 \'95\b0\fs22\f3 is the task done consistently ona person-to-person, day-to-day basis?

\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 do the interfaces between the departmentsoperate smoothly? \b\fs22\f4 \u8226 \'95\b0\fs22\f3 does product and informationflow freely?\b\fs22\f4 \u8226 \'95\b0\fs22\f3 is the procedure right? \b\fs22\f4\u8226 \'95\b0\fs22\f3does it meet the Standard? \b\fs22\f4 \u8226 \'95 \b0\fs22\f3 is it helping theorganisation effectively?\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4 Thereis clearly no advantage in verifying that the procedure is being followed if theresult is not beneficial to the organisation, and consequently, the customers\b0\fs22\f3 .\cf0\fs22\ulnone\strike0\par\pard\s5\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf2\fs22 10 B -How do I audit without procedures?\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22 In cases

where the organisation has chosen not to have a documented procedure to control aprocess, the first step must be to establish what method it has chosen, whether bya competent person, software or any other appropriate means.\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22From there the auditor can evaluate the effectiveness of the process by testing toensure that it is being performed consistently, and by comparing it to the\b\fs22\f4 appropriate clauses of ISO 9001\b0\fs22\f3 .\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4 Somerequirements are general\b0\fs22\f3 and apply to most areas of the organisatione.g. controlled documents (4.2.3), records (4.2.4), responsibility, authority &communication (5.5), competence and training (6.2.2), identification &traceability (7.5.3).

\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4Others are \lquote area specific'\b0\fs22\f3 e.g. 7.2 is mostly about the salesactivities, 7.4 for purchasing. Select the \b\fs22\f4 \lquote predominant'\b0\fs22\f3clause for the process being audited plus the more general ones, and you should beable to verify both the effectiveness of the process (see 10a) and also itscompliance to the Standard. This can prove to be particularly useful whenperforming internal audits, as it helps the organisation to satisfy therequirement in clause 8.2.2 which requires us to "\u8230 \'85. determine whetherthe quality management system conforms to\b\fs22\f4 planned arrangements\b0\fs22\f3 , to the requirements of this\b\fs22\f4 International Standard\b0\fs22\f3 and to the quality management

\b\fs22\f4 system requirements\b0\fs22\f3 established by the organisation\u8230 \'85"\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf2\fs22\f4Consider these points:\b0\cf0\fs22\f3\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\ql\stextflow0\b\cf1\fs22\f4\u8226 \'95 \b0\fs22\f3 is there continuity between the various processes in theorganisation? \b\fs22\f4 \u8226 \'95\b0\fs22\f3 is the task done consistently ona person-to-person, day-to-day basis?\b\fs22\f4 \u8226 \'95 \b0\fs22\f3 do the interfaces between the departmentsoperate smoothly? \b\fs22\f4 \u8226 \'95\b0\fs22\f3 does product and informationflow freely? \b\fs22\f4 \u8226 \'95\b0\fs22\f3 does it meet ISO 9001? \b\fs22\f4


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\u8226 \'95 \b0\fs22\f3is it helping the organisation effectively?\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\fs22 \cf2\fs22Summary\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22 All thesequestions are based on specific ISO 9001 requirements. In the light of ISO9001:2008 Para. 8.2.2 the unavoidable implication is that internal auditors mustnow have an understanding of ISO 9001, rather than solely focusing on procedures.

\cf0\fs22\ulnone\strike0\par\pard\pagebb\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22 Anaudit of your key quality management activities will always be more relevant andproduce more meaningful results than a simple procedural audit. Most of thesehigh-level questions can also used to supplement your own checklists as part ofyour routine internal audits. You may well want to refine this list based onspecial concerns and risks faced by your company. Decide what matters most to yourorganisation and focus your audit process on those aspects.\cf0\fs22 \ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22Follow this link to the\cf0\fs22 {\field{\*\fldinst {HYPERLINK"http://isotc.iso.org/livelink/livelink/fetch/2000/2122/138402/138403/3541460/customview.html?func=ll&objId=3541460&objAction=browse&sort=name"}}{\fldrslt{\cf3\fs22

{\ul ISO 9001 Audit Practices Group}\ulnone\strike0}}}\cf7\fs22 \cf1\fs22 andlearn more about modern audit techniques. The leading UK Certification Bodies{\field{\*\fldinst {HYPERLINK "http://www.nqa.com/guide11.html"}}{\fldrslt{\cf3\fs22{\ul NQA}\ulnone\strike0}}}\fs22\cf1\fs22 and {\field{\*\fldinst {HYPERLINK"http://www.lrqa.com/comsite/template.asp?name=review"}}{\fldrslt {\cf3\fs22{\ulLloyds Register Quality Assurance}\ulnone\strike0}}}\cf1\fs22 both provide free,and useful information on 21st Century quality thinking.\cf0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\fs22\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\b\cf1\fs22\f4IMPORTANT NOTICE \b0\cf0\fs22\f3\ulnone\strike0\par\pard\sa100\sb100\fi0\ri0\li0\qj\stextflow0\cf1\fs22

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Documents

ISO 9000_2001 - Do Your Quality Objectives Deliver Real Results