【導(dǎo)讀】Determinationofthe―whereappropriate‖processes確定”適當(dāng)?shù)摹边^程。Auditingthe―whereappropriate‖requirements審核”適當(dāng)?shù)摹币?

　　

【正文】 detail and styles will vary greatly from one auditor to another. 這也是對審核員的要求，證明執(zhí)行審核的順序，有時叫審核路線。對于審核員記錄審核，使用審核筆記是很有效的方法。使用審核筆記主要不足是趨向于非常人個化的方法記錄審核信息，每個審核員的記錄詳細(xì)程度和類型都有很大的不同。 A checklist can ensure some uniformity in the performance of the auditors. However, auditors should never fet to spend their time auditing, not filling out checklists or taking notes. 檢查表可確保審核員的一致性。但是，審核員不應(yīng)忘記時間的分配，而不是填寫檢查表或?qū)徍斯P記。 Linking an audit of a particular task, activity or process to the overall system 體系特定的任務(wù)、活動或過程的審核 The auditor should not lose sight of the overall direction of the audit, and get sidetracked by superfluous details. It is important that the auditor keep a close eye on the information provided by the auditee in the quality manual or documentation where the auditee has defined the interaction of processes. Interviews should also be performed in such a way that the auditors should determine the input and output of the process being audited. Keeping in mind the auditee39。s process map should ensure that the auditor will be able to determine the importance of the process he is auditing at any time, and will therefore be able to keep sight of the overall direction of the audit. This will also help the auditor to understand the linkage between the processes. 審核員不能忽視審核的全面趨勢，獲取邊緣資料。重要的是審核員應(yīng)密切關(guān)注質(zhì)量手冊或定義過程接口的文件中受審核方提供的信息。審核員應(yīng)確定受審核的過程輸入和輸出。關(guān) 注受審核方的過程圖，以確保審核員任何時候都有能力確定過程的重要性，因而能夠看到審核的全面趨勢。這樣也有助于審核員理解過程間的聯(lián)系。 During an audit, the auditor has an opportunity to check the auditee39。s description of the interrelation of its processes. The auditor should take some samples to see if the descriptions are a proper reflection of the actual interrelation of the processes, as this will help determine if the process description is adequate. ISO 9001 Auditing Practices Group 169。 ISO amp。 IAF 2020 – All rights reserved 。 在審核期間，審核員有機(jī)會檢查受審核方對過程相互關(guān)系的描述。審核員應(yīng)抽樣看描述是否反映過程的相互關(guān)系，以便確定過程描述是否充分。 ISO 9001 Auditing Practices Group 169。 ISO amp。 IAF 2020 – All rights reserved 。 Auditing continual improvement 審核持續(xù)改進(jìn) How much improvement is “enough”?多少改進(jìn)才“足夠” It should be emphasised that the requirement in ISO 9001:2020 is for continual improvement of the effectiveness of the QMS. ISO 9001:2020 強(qiáng)調(diào)持續(xù)改進(jìn)質(zhì)量管理體系的有效性。 Continual improvement emanates from the objectives set by top management, which should (at least) address: the improvement of internal efficiency (for the anization to remain economically petitive), individual customer needs, and the level of performance that the market normally expects. 持續(xù)改進(jìn)源于最高管理者設(shè)定的目標(biāo)， (至少 )說明：內(nèi)部效率 (組織保持經(jīng) 濟(jì)競爭力 )的改進(jìn)，單個顧客需求和市場正常期望的業(yè)績水平。 For example, in the aeronautical sector, the ―acceptable rate‖ of nonconforming delivered product is zero percent, so it would not be useful for the anization to set objectives for an ―improvement― in this rate. However, it would be useful for the anization to have objectives aimed in improving its internal efficiency and its petitiveness (. through innovation). 例如，對于 航空業(yè)，交付不合格品的接受率為零，所以組織不能用此作為目標(biāo)改進(jìn)。但是，組織可以改進(jìn)其內(nèi)部效率和競爭力作為目標(biāo) (如通過創(chuàng)新 )。 The auditor should seek to determine if the auditee has attempted to set objectives that establish the correlation between the 3 factors of: corporate objectives, customer needs, and market expectations. Thereafter, it is up to the anization to balance the need for improving internal efficiency and the need to progress with external performance (although the two are very often closely related). No one in isolation can ever be considered as being ―enough‖ or ―not enough‖. 審核員應(yīng)確定受審核方設(shè)定目標(biāo)建立以下 3 方面的關(guān)系：公司目標(biāo)，顧客需求和市場期望。隨后組織平衡其內(nèi)部效率改進(jìn)需求和外部業(yè)績 (這兩項(xiàng)通常緊密相關(guān) )發(fā)展需求。不可孤立地考慮是否足夠。 One area which can be problematic for the auditor is to know what is a reasonable market benchmark. Continuing the above aeronautical example, if the anization announced that it had improved from a level of 50% nonconforming product delivered to 40%, this would demonstrate continual improvement, but would hardly be acceptable, given the industry sector39。s zero percent normal rate. However, if it announced that it had set an objective to improve its performance from 0,50% to 0,40%, this would be much nearer the market norm. 對于審核員有一處問題是什么是合理的市場績效。繼續(xù)上面 航空的例子，如果組織告知從 50%的交付不良品率改進(jìn)到 40%，這可證明持續(xù)改進(jìn)，但是對于行業(yè)內(nèi)零缺陷卻是不能接受的。但是，告知其績效從 0,50%改進(jìn)到 0,40%，這樣就比較接近行業(yè)正常水平。 The only real solution for the auditor is to verify how the anization has determined this proposed rate of improvement, how it has evaluated the associated risks, and how this relates to customer requirements and the monitoring of feedback on customer satisfaction. It would be almost impossible to issue an NCR that stated ―There was not enough continual improvement‖. 審核員最真實(shí)的解決方法就是驗(yàn)證組織 如何確定其改進(jìn)比率，如何評價其關(guān)聯(lián)風(fēng)險，如何考慮顧客要求和顧客滿意反饋的監(jiān)視。幾乎不可能開出 NCR“持續(xù)改進(jìn)不夠”。 What sort of information is relevant and where can we find it?相關(guān)信息和何處可發(fā)現(xiàn)？ The auditor has to verify how the overall corporate objectives have been translated into internal requirements throughout the appropriate processes, and how these requirements are municated and monitored. So, the auditor should look for evidence that the anization is analysing data from process monitoring, and is then taking the results forward for evaluating process efficiency and/or improving process output. One point that should be specifically ISO 9001 Auditing Practices Group 169。 ISO amp。 IAF 2020 – All rights reserved 。 examined, is the consistency of the way in which the improvement of any one process contributes to meeting the overall objectives, in order to ensure that this will not cause conflict in the achievement of other objectives. 審核員須驗(yàn)證公司目標(biāo)如何通過必適當(dāng)?shù)倪^程轉(zhuǎn)化為內(nèi)部要求，以及這些要求如何溝通和監(jiān)視。因此，審核員應(yīng)尋找組織分析過程監(jiān)視數(shù)據(jù)，并利用結(jié)果評價過程效率和 /或改進(jìn)過程輸出的證據(jù)。有一點(diǎn)要特別注意，任何一個過程對滿足目標(biāo)的貢獻(xiàn)的改進(jìn)，以確保不會引起達(dá)成目標(biāo)的抵制。 The type of information that an auditor needs to look for, is evidence of how the corporate objectives are translated into specific QMS objectives. For example: an aniza