作者：文思特咨詢師杜建生
讀者朋友，您好。
春天的腳步已經(jīng)向我們走來。新春之際，美國質(zhì)量協(xié)會ASQ推出了《質(zhì)量工具箱第3版（Quality Toolbox 3rd Edition）》。該工具箱中介紹了近148種質(zhì)量工具以適用于不同行業(yè)的質(zhì)量職能（非質(zhì)量部門）人員參考使用。
本文就工具書的一些主要變化進行介紹，供您參考。
《質(zhì)量工具箱》被認為自出版以來最受歡迎的質(zhì)量讀物（2005年第2版以來），第3版進行了全面的修訂和更新，以適應當前的情形和挑戰(zhàn)。
作者注：本書第2版的中文版由中國標準出版社出版，何楨、施亮星主譯，各書店有售。
第3版的一些突出變化是：
— 增加了質(zhì)量4.0（建議的質(zhì)量工具）介紹
— 增加了汽車行業(yè)普遍使用的工具，如控制計劃
— 收錄了一些其它工具，如九窗法
— 對個別工具進行了修改，如雷達圖、盒形圖等
閱讀這本書，掌握書的閱讀指南（書籍的第1章）非常關(guān)鍵，它能幫您快速找到想要了解的工具（結(jié)合10步法工具矩陣）。
1. 我們想用這個工具做什么？
（每一個工具下面，可能會出現(xiàn)以下標識，用于工具分類使用的選擇）
2. 我們的質(zhì)量改進進程進展如何？
3. 我們需要思維發(fā)散還是聚焦？
本短文摘抄了其中兩個片段供您選讀：
片段1：
就汽車供應鏈常用的“控制計劃”工具做介紹。
《AIAG 控制計劃 第1版》發(fā)布在即，我們拭目以待，之后可以關(guān)注并比較兩本出版物中的異同點。
同樣，讀者朋友也可以將IATF 16949 8.5.1.1條款及附錄A對“控制計劃”的要求與SAE（AS13004 PFMEA and Control Plans）中對“控制計劃”的要求進行對比。目的是讓“控制計劃”成為一份“真”的“有作用”文件。
片段2：
簡要介紹數(shù)字時代的工業(yè)4.0和質(zhì)量4.0
以下是分享的部分：
Also called: process control plan
又名：工序控制計劃
Description
描述
A control plan is a document that describes how the desired quality output of a process will be maintained. For each critical quality characteristic, the plan states specifications, actions to measure and monitor them, and actions to take if the characteristic is outside limits.
控制計劃是一份描述如何保持工序預期質(zhì)量輸出的文件。對于每個關(guān)鍵質(zhì)量特性，計劃都會明示規(guī)范、測量和監(jiān)視措施，以及特性超限時應當采取的措施。
When to Use
何時應用
• When a part or process is under development, to control key measurements, materials, and performance of the prototype or pre-launch product, or …
• 當零件或工序處于開發(fā)時，對原型樣件或試生產(chǎn)產(chǎn)品的關(guān)鍵測量、材料和性能進行控制，或...
• After improving a process, to plan how to maintain the gains, and then …
• 過程改進后，要計劃如何保持收益，然后...
• Throughout the life of the process, to monitor and control variation, especially…
• 過程整個生命周期，以監(jiān)視和控制變差，特別是...
• When training people to operate the process, and …
• 培訓人員以運行過程，且…
• When process measures are outside limits, to know how to react
• 當測量過程發(fā)生超限時，要知道如何應對
Procedure
程序
1. Identify process steps, typically using a flowchart.
1. 確定工序步驟，通常使用流程圖。
2. Fill in identifying information in the top section of a form like Figure 5.40.
2. 在類似圖5.40所示的表格表頭填寫標識信息。
3. Work on one process step at a time. Identify the process step (or part number, for an assembly), description, and machine or tool used. List them in the first columns.
3. 一次只處理一個工藝步驟。確定工序步驟（或零件號，用于裝配）、描述以及使用的機器或工具。將它們列在第一欄中。
4. Characteristics: Identify product and process characteristics that need to be controlled at that process step. Then do steps 5 and 6 for just one characteristic at a time.
4. 特性：確定該工序步驟中需要控制的產(chǎn)品和過程特性。然后，每次只針對一個特性執(zhí)行步驟5 和6。
5. Methods: Identify the methods to be used to monitor the characteristic. List the specification, measurement or evaluation technique, sample size, sampling frequency, and the control method or chart used.
5. 方法：確定用于監(jiān)視特性的方法。列出規(guī)范、測量或評估技術(shù)、樣本量、抽樣頻率以及使用的控制方法或圖表。
6. Reaction plan: Define what to do if the characteristic is outside the limits.
6. 反應計劃：特性超限時確定做什么。
7. Repeat steps 5 and 6 for each characteristic. Then repeat steps 3 to 7 for each process step.
7. 針對每個特性重復進行步驟5和6。然后對每個工序步驟重復進行步驟3至7。
Example
示例
Figure 5.40 shows two rows from ZZ-400’s control plan, established after the purity team had reached their goals. They had identified preheat temperature as one of the critical characteristics affecting final product quality. It is continually monitored by an automatic temperature controller, which sounds an alarm if the temperature varies from its setting. If that happens, operators follow Procedure ZZ-5. Product purity, a key characteristic of final product quality, is monitored by an X and R chart, using samples taken once per shift. If the process becomes out of control, operators follow Procedure ZZ-41.
圖5.40顯示了ZZ-400控制計劃中的兩行，這是在純度團隊達到目標后制定的。他們確定預熱溫度是影響最終產(chǎn)品質(zhì)量的關(guān)鍵特性之一。預熱溫度由自動溫度控制器持續(xù)監(jiān)控，如果溫度偏離設(shè)定值，控制器就會發(fā)出警報。如果出現(xiàn)這種情況，操作員就會按照 ZZ-5 步驟進行操作。產(chǎn)品純度是完成品質(zhì)量的一個關(guān)鍵特性，通過X和R（均值極差）圖進行監(jiān)控，每班取樣一次。如果過程失控，操作員將按照程序ZZ-41進行操作。
圖5.40 控制計劃示例
Considerations
注意事項
• Control plans help a team think about and formalize how to monitor and control critical variables that affect variation and, therefore, determine whether customer requirements can be met. In Six Sigma, control plans are developed during the C (control) phase of DMAIC to monitor critical-to-quality (CTQ) characteristics, also called the critical Xs and Ys of the product and process.
• 控制計劃可以幫助團隊思考如何監(jiān)控影響變差的關(guān)鍵變量，從而確定能否滿足客戶要求。在六西格瑪中，控制計劃是在DMAIC 的C（控制）階段制定的，用于監(jiān)控關(guān)鍵質(zhì)量（CTQ）特性，也稱為產(chǎn)品和過程的關(guān)鍵 X 和 Y。
• If your organization or customer requires control plans, there will be a standard template. If not, choose or develop a format based on your organization’s needs.
• 如果您的組織或客戶需要控制計劃，則會有一個標準模板。如果沒有，請根據(jù)您組織的需求選擇或開發(fā)一種格式。
• The control plan may be for a part or a process. If you are addressing a family of parts produced in one process, do a control plan for the process.
• 控制計劃可以是針對零件或過程的。如果是針對一個過程中生產(chǎn)的一系列零件（族），則應針對該過程制定控制計劃。
• Information for the control plan can come from many sources, such as the PFMEA or DFMEA, process flow diagram, part or assembly drawings, design reviews, cause-and-effect diagrams, other root cause analysis tools, statistical studies, and team knowledge.
• 控制計劃的信息有很多來源，如PFMEA或DFMEA、工藝流程圖、零件或裝配圖、設(shè)計評審、因果圖、其他根本原因分析工具、統(tǒng)計研究和團隊知識等。
• Identifying information at the top of the control plan should include part or process name and number, revision and original document dates, and contact information for the person responsible for the plan, preferably the process owner.
• 控制計劃頂部的標識信息應包括零件或過程名稱和編號、修訂和初始文件日期，以及計劃負責人（最好是過程所有者）的聯(lián)系信息。
Characteristics
特性
• Product characteristics can be measured or identified on the product itself.
Process characteristics are aspects of the process that affect the quality of what it produces. They are likely to be closer to the root cause of problems.
• 產(chǎn)品特性可以對產(chǎn)品自身進行測量或識別。過程特性是指影響生產(chǎn)質(zhì)量的過程的各個方面。它們可能更貼近問題的根本原因。
• Some plans include a column for special characteristics. These are characteristics that need special attention due to their impact on form, fit, function, or safety. Some control plans have a column to check to identify CTQ characteristics.
• 有些計劃包括一個特殊特征欄。這些特性因其對形狀、裝配、功能或安全的影響而需要特別注意。有些控制計劃有一欄用于檢查，以確定CTQ特性。
Methods
方法
• The specification may be qualitative or quantitative. A qualitative specification might not have a tolerance.
• 規(guī)范可以是定性的，也可以是定量的。定性規(guī)范可能沒有公差。
• Measurement system analysis should have been done for the measurement system(s) and should be repeated regularly. Results from the study are sometimes listed on the control plan.
• 應當針對測量系統(tǒng)進行測量系統(tǒng)分析，并定期進行再分析。研究結(jié)果有時會在控制計劃中列出。
• In discrete manufacturing, the sample size is how many pieces are selected. These pieces will form one subgroup for monitoring on an X and R chart.
• 在離散制造中，樣本量是指被選定的件數(shù)。這些工件將形成一個子組，在 X 和 R（均值極差） 圖上進行監(jiān)控。
• Typical sample frequencies might be first and last parts produced, last parts only, random sampling, or first and last parts plus parts after tool or material changes.
• 典型的抽樣頻次可能是生產(chǎn)的首件和末件、僅末件、隨機抽樣，或者首/末件加上工具或材料更換后的零件。
• Sample frequencies for random failures should be based on how often the failures are known to occur.
• 隨機故障的抽樣頻次應當基于已知故障發(fā)生的頻率。
• Some control plans distinguish between “control methods: prevention” and “control methods: detection.” Prevention methods include work instructions, drawings, and mistake-proofing. Detection methods include statistical process control (SPC), visual inspection, and automated controls.
• 有些控制計劃分為“控制方法：預防”和“控制方法：探測”。預防方法包括工作指導書、圖紙和防錯。探測方法包括統(tǒng)計過程控制 (SPC)、目視檢查和自動化控制。
Reaction plan (or corrective action)
反應計劃（或糾正措施）
• The reaction plan should describe actions to be taken by the process operator or the immediate supervisor. It should include actions to ensure defective product does not get to the customer, actions to find the source of the problem, and actions to document and report the situation.
• 反應計劃應當說明過程操作人員或直接主管應采取的措施。其中應當包括確保缺陷產(chǎn)品不流入客戶端的措施、查找問題根源的措施以及記錄和報告情況的措施。
• When developing the reaction plan, think about who, what, when, and where.
• 在制定反應計劃時，要考慮由誰、做什么、何時、何地。
• If the reaction plan is lengthy, the chart can refer to a separate reaction plan document.
• 如果反應計劃較長，圖中可引用單獨的反應計劃文件。
Developing and using the control plan
制定和使用控制計劃
• The control plan is usually developed by the team working on process improvement. After the control plan has been developed, train all the process operators, supervisors, and the process owner.
• 控制計劃通常由過程改進團隊制定。制定控制計劃后，對所有過程操作人員、主管和過程所有者進行培訓。
• The control plan does not replace work instructions and standard operating procedures for the process operators.
• 控制計劃不能取代過程操作人員的工作指導書和標準操作程序。
• The purpose of the control plan is to ensure that improvements made to the process do not degrade over time. Therefore, the control plan must be a document that can be easily understood and used by the process operators. It also must be periodically reviewed and updated.
• 控制計劃的目的是確保對過程的改進不會隨著時間的推移而退化。因此，控制計劃必須是過程操作人員易于理解和使用的文件?？刂朴媱澾€必須定期評審和更新。
片段2：
簡要介紹數(shù)字時代的工業(yè)4.0和質(zhì)量4.0，具體內(nèi)容見續(xù)篇。
