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偏差調查中常見8大問題

By James Blackwell, Ph.D., The Windshire Group, LLC

Deviationinvestigations are one of the most important quality activities in any GMP(good manufacturing practice) organization. They are also perennially near thetop of the list of most frequently cited issues in observations, warningletters, and consent decrees from the U.S. Food and Drug Administration (FDA)and other regulatory authorities.1 (“There is a failure to thoroughly review [any unexplained discrepancy][the failure of a batch or any of its components to meet any of itsspecifications] whether or not the batch has been already distributed.”)

偏差調查是任何GMP組織中最重要的質量活動之一。在FDA和其他監管機構發布的觀察、警告信和同意令中，它們也一直處于最常被引用的問題列表的首位。1(“無論批次是否已經分發，都沒有徹底審查[任何無法解釋的差異][批次或其任何部件沒有達到任何規格]。”)

Clearly,many organizations have room to improve in the writing and managing ofdeviation investigations. The following sections identify common misstepscompanies make when conducting deviation investigations — and how you can avoidthem.

顯然，許多組織在偏差調查的編寫和管理方面仍有改進的余地。以下幾節列出了公司在進行偏差調查時所犯的常見錯誤以及如何避免這些錯誤。

1.Not leveraging historical data for continuous improvement

Theinformation gathered over time through investigations contains a wealth of datathat can be used for continuous improvement, increasing productivity, andreducing the recurrence of investigations. Unfortunately, many organizationsonly review this data once a year and in a somewhat perfunctory manner.

Agood trending process is an important element in monitoring and proactivelyresponding to developing issues. Tracking investigation data (root cause,functional group, unit operation) will aid in continuous monitoring of thetypes of events and root causes occurring in your facility by product, processarea, and functional group, among others.

Developa list of standard event categories and actionable root causes in order totrend deviation and investigation data. This list can be upwards of 200 or moreand can aid investigators in writing their root cause in actionable terms. 

1.不利用歷史數據進行持續改進

隨著時間的推移，通過調查收集到的信息包含了大量的數據，可用于不斷改進、提高生產力和減少調查的再次發生。不幸的是，許多組織每年只審查這一數據一次，而且有些敷衍了事。一個良好的趨勢過程是監測和積極應對發展中問題的一個重要因素。跟蹤調查數據(根本原因、功能組、單元操作)將有助于持續監控設備中按產品、流程區域和功能組等發生的事件類型和根本原因。制定標準事件類別和可采取行動的根本原因清單，以便趨勢偏差和調查數據。這份清單可以超過200份或更多，可以幫助調查人員以可訴的方式寫出他們的根本原因。

2.Relying on human error as a root cause
Thisis a common finding that regulatory authorities will cite in theirobservations. Repeatedly stating human error as a root cause is a sign thatyour organization is not interested and/or resourced to find true root causesand to correct the underlying issues behind recurrence.
Humanerror can be a root cause category, but rarely is it the true and actionableroot cause, in and of itself. The true root cause is usually in other areas,such as procedures (“step x.x unclear”), training (“wasn’t assigned training onprocedure since SOP was not on training curriculum”), environment (“distractiondue to false fire alarm”), or machine (“improper equipment design and layout”).
Itis important to find a true, underlying root cause and to describe it inactionable terms to prevent recurrence and reduce the number of future humanerror-related events. Such events cost the industry a staggering amount interms of lost productivity, compliance and labor costs, and the human resourcesneeded to investigate nonconformances. The average cost of a deviation runsinto tens of thousands of dollars for major pharmaceutical companies.Preventing human error recurrence not only saves organizations money, but itreduces the likelihood of compliance issues, including regulatory findings.
Somequality systems will not allow human error to be used as a root cause, in orderto prevent the organization from stopping short of identifying and addressingthe true root cause behind errors (see error #3 below). For example, in many(but definitely not all) human error events, the employee involved could havedetected the error prior to it becoming a deviation. Therefore, “inadequateability to detect the problem” could be the actionable root cause in suchsituations. The resulting CAPA (corrective and preventive action) would becounseling or additional training that focuses on increasing the person’sability to detect and fix an error, or other job aids or improvements in theHMI (human machine interface) that will allow operators to better detectproblems in time to prevent a deviation. Counseling just on “paying attentionto detail” or on “the importance of GMPs” is not specific or adequate as astandalone CAPA. If someone doesn’t understand the importance of GMPs, theyshouldn’t be working in a GMP environment — and they definitely need moretraining.

2.把人為錯誤作為根本原因

這是監管當局在其意見中引用的共同結論。將人為錯誤反復聲明為根本原因是一個跡象，表明您的組織沒有興趣和/或資源來尋找真正的根本原因，并糾正重復出現的根本問題。人的錯誤可以是一個根本原因范疇，但它很少是真正的和可行動的根本原因本身。真正的根本原因通常是在其他領域，如程序(“步驟x.x不明確”)、培訓(“由于SOP沒有列入培訓課程而沒有被分配關于程序的培訓”)、環境或機器(“設備設計和布局不當”)。
重要的是找到一個真正的、潛在的根源，并以可操作的方式描述它，以防止再次發生，并減少今后與人類錯誤相關的事件的數量。這類事件在生產力損失、合規和勞動力成本以及調查不合格行為所需的人力資源等方面給行業造成了驚人的損失。對于大型制藥公司來說，偏差的平均成本高達數萬美元。防止人為錯誤的再次發生不僅節省了組織的資金，而且降低了合規問題的可能性，包括監管結果。一些質量系統將不允許將人為錯誤用作根本原因，以防止組織無法識別和解決錯誤背后的真正根源(見下面的錯誤#3)。例如，在許多(但肯定不是所有)人為錯誤事件中，所涉及的員工可以在錯誤變成偏差之前檢測到錯誤。因此，在這種情況下，“發現問題的能力不足”可能是可采取行動的根本原因。由此產生的CAPA(糾正和預防行動)將是咨詢或額外培訓，重點是提高個人檢測和修復錯誤的能力，或其他工作輔助或改進人機界面(HMI)，使操作者能夠及時更好地發現問題，以防止出現偏差。僅僅就“注重細節”或“GMPS的重要性”進行咨詢，作為一個獨立的CAPA來說，是不具體的，也是不夠的。如果有人不理解GMP的重要性，他們就不應該在GMP環境下工作，而且他們肯定需要更多的培訓。

3.Not getting to the probable root cause
Thepercentage of investigations resulting in a root cause is a good metric for thehealth of your quality system — the higher the percentage, the better. Thereare many reasons why root causes are not found. Not committing adequate timeand resources is one. However, it is all too common for organizations to put insufficient effort, gather all the necessary facts and information, but stillfail to identify a root cause. Sometimes, this is the direct result of theinvestigator’s skill — they may have been trained insufficiently or lacktechnical command of the issues involved.
However,it is also surprisingly common for an investigation to conclude that a“definitive” root cause could not be identified, despite the fact that all thenecessary information is available and the conclusion is readily discernable. Amisguided interpretation of the facts or an unrealistic notion of definitivecan prevent the investigation from arriving at a most probable root cause.There is no regulatory standard that requires all investigation conclusions bedefinitive. A most probable root cause based on and justified by a thoroughinvestigation and supported by the available data and information issufficient.
Theproper RCA (root cause analysis) tool should be chosen for the problem at hand.For more difficult investigations, a Kepner-Tregoe or IS-IS NOT analysis canoften tease out a challenging most probable root cause from an array ofdiscordant facts.

3.沒有找到可能的根本原因

導致根本原因的調查百分比-是衡量質量體系健康的一個很好的指標-這個百分比越高，越好。根本原因是多方面的。沒有投入足夠的時間和資源是其中之一。然而，各組織作出足夠的努力，收集所有必要的事實和信息，但仍然找不到根本原因，這是非常普遍的。有時，這是調查人員技能的直接結果-他們可能沒有受過充分的培訓，或對所涉問題缺乏技術上的掌握。然而，令人驚訝的是，調查得出的結論也令人驚訝，即無法查明“確定的”根本原因，盡管有所有必要的資料，而且結論是顯而易見的。對事實的錯誤解釋或不現實的確定性概念可能會使調查無法找到最可能的根本原因。沒有任何監管標準要求所有調查結論都是確定的。一個最可能的根本原因是以徹底調查為基礎并以現有數據和資料為依據的，這就足夠了。對于手頭的問題，應該選擇合適的RCA(根原因分析)工具。對于更困難的調查，Kepner-Tregoe或is-不是分析，通常可以從一系列不一致的事實中找出最具挑戰性的最可能的根本原因。

4.Not getting to the true root cause
Findingthe true root cause is critically important. There have been many cases whereorganizations failed to identify and correct the true root cause of a problemthat was readily solvable — and they suffered millions of dollars in losses (orworse) as a result. The true root cause is an actionable one that is the mostconsistent with the available facts and information from a thoroughinvestigation and can be the most probable root cause mentioned above.
Atrue root cause is the underlying reason that allowed the event to occur.Understanding the true root cause requires the collection of all relevantfacts. Sometimes, these are clearly understood at the time of the event. Othertimes, it requires in-depth technical assessments that can span several months.
Onegood test for assessing if the true root cause has been found is to see if itcan be stated in terms that are directly actionable, meaning it links clearlyto a corrective action and is within the organization’s control. A simple andeffective way to determine if the true, actionable root cause has been found isto use the 5 Whys tool at the conclusion of an investigation, includingapplication to the outputs from more advanced tools, such as a fishbone diagramor Kepner-Tregoe analysis.
Forexample, failure of the backup power supply is not a true, actionable rootcause. Why did the back-up power supply fail? Hurricane Matthew cannot belisted as an actionable root cause, because the organization cannot preventhurricanes. However, an inadequate procedure for preventative maintenance ofthe backup power supply can be a true root cause, in which case the correctiveaction is to fix the procedure.

4.找不到真正的根源

找到真正的根源是至關重要的。在許多情況下，組織未能找出和糾正一個容易解決的問題的真正根源-結果他們遭受了數百萬美元的損失(甚至更糟)。真正的根本原因是一個可采取行動的原因，這是最符合現有的事實和資料，從一個徹底的調查，可以是最可能的根本原因，上述提到。真正的根本原因是允許事件發生的根本原因。了解真正的根本原因需要收集所有相關的事實。有時，這些在事件發生時就被清楚地理解了。其他時候，它需要深入的技術評估，可以跨越幾個月.評估是否找到了真正的根本原因的一個很好的測試是，看看是否可以用可以直接采取行動的術語來說明這一問題，這意味著它與糾正行動有著明確的聯系，屬于組織的控制范圍。一個簡單而有效的方法，以確定是否找到了真正的，可采取行動的根本原因是使用5 Whys工具在調查結束，包括應用于更先進的工具，如魚骨圖或Kepner-Tregoe分析（KT法，問題解決技巧-方法）。例如，備份電源的故障不是真正的、可采取行動的根本原因。為什么備用電源失靈？颶風馬修不能被列為可采取行動的根本原因，因為該組織無法防止颶風。然而，后備電源預防性維護程序不足可能是真正的根本原因，在這種情況下，糾正措施是修復程序。

5.Preparing an unclear or difficult-to-follow investigation report
Manyinvestigation writers forget that their audience is not only internalemployees, but ultimately an external third-party, such as an inspector. Thus,the investigation needs to be readily understandable and clear, with all thenecessary supporting facts and rationale, so that it is comprehensible yearsafter the event. The most difficult challenge in accomplishing this is writinglogically, clearly, and succinctly, without presenting and repeating redundantinformation. Thus, training is an important element of writing effectiveinvestigations. Having mentors available to assist investigators can be animportant element in advancing skills.

5.準備一份不明確調查報告

許多調查作者忘記了，他們的聽眾不僅是內部員工，而且最終還是外部第三方，比如檢查員。因此，調查必須易于理解和明確，并有所有必要的支持事實和理由，以便在事件發生后幾年才能理解。要做到這一點，最困難的挑戰是在不顯示和重復冗余信息的情況下，以邏輯、清晰和簡潔的方式書寫。因此，培訓是編寫有效調查的重要內容。有導師協助調查人員可能是提高技能的一個重要因素。

6. Ignoring contributing factors and associatedCAPAs
Contributing factors are elements that eitherwere necessary — in addition to the root cause — for an event to occur, or thatincreased the event’s impact. Contributing factors also require root causedeterminations and CAPAs. Addressing them limits the likelihood or impact ofsimilar events recurring in the future. Too often, investigations focus only onthe root cause and forget to address contributing factors. Use of the 5-Whystool is a useful mechanism to distinguish contributing factors from rootcauses.

6.忽視影響因素及相關因素

除了根本原因之外，造成事件發生的因素或者是必要的，或者是增加了事件的影響的因素。造成因素也需要根本原因的確定和卡帕。解決這些問題限制了今后再次發生類似事件的可能性或影響。調查往往只關注根本原因，而忘了處理促成因素。使用5-Whys工具是區分成因和根源的有用機制。

7. Prescribing inadequate CAPAs
Too many investigations lead to an appropriateroot cause but never link that cause to a CAPA. Most root causes andcontributing factors should be associated with one or more CAPAs; if not, aclearly justified rationale should be provided. One of the main purposes of aninvestigation is to prevent recurrence of the event, and this can only happenif the investigation determines a root cause and connects it to an appropriate,effective CAPA. Another consideration is whether or not an interim control isneeded while the CAPA(s) is being implemented. A risk assessment should be usedto make this determination.

7.開具不足的Capa

太多的調查導致了一個適當的根本原因，但從來沒有將這一原因與CAPA聯系起來。大多數根源和促成因素應與一個或多個CAPA相關聯；如果沒有，則應提供明確的理由。調查的主要目的之一是防止事件再次發生，只有當調查確定了根本原因并將其與適當的、有效的CAPA聯系起來時，才能發生這種情況。另一個考慮因素是在實施“CAPA”時是否需要臨時控制。應利用風險評估來作出這一決定

8. Not performing interviews
Too many investigations fail to obtaininformation from the employees with the most relevant insight and informationsurrounding the event, either because the interviews are never conducted orthey occur too long after the event. Memories fade quickly, so interviewsshould be conducted as soon as possible after an event occurs. Someorganizations “swarm” an event immediately after it happens, with a teamconducting interviews. This is called “freezing the scene.” Gatheringhigh-quality information soon after the event will save you future time andeffort, and improves the quality of the investigation.
Talking to key personnel using well thought-outinterview questions prepared in advance, when applicable, will make theinterview more useful and insightful and the investigation much more efficient.The essential details of interviews should be summarized in the investigation.

8.不進行采訪

太多的調查無法從員工那里獲得與事件相關的洞察力和信息，要么是因為調查從未進行，要么是在事件發生后太久才進行。記憶很快就會消失，所以調查應該在事件發生后盡快進行。一些組織在事件發生后立即“蜂擁而至”，由一個團隊進行采訪。這就是所謂的“凍結現場”。事后收集高質量的信息將節省你今后的時間和精力，并提高調查的質量。在適當的情況下，用事先準備好的面試問題與關鍵人員交談，會使調查更有用、更有洞察力，調查也更有效率。采訪的基本細節應在調查中加以總結。
Conclusion
While conducting a thorough deviationinvestigation is hard work, failing to do so will yield inaccurate root causesand misdirected CAPAs, and recurring deviations, along with increasedregulatory and financial risk. The payback from investing in deviationinvestigations comes in the form of improved operational performance, reductionin costs, increased quality, and improved compliance.

結論

盡管進行徹底的偏差調查是一項艱巨的工作，但如果不這樣做，將產生不準確的根本原因和錯誤的CAPA，以及重復的偏差，并增加監管和金融風險。增加對偏差調研的投入可改進操作性能、降低成本、提高質量和提升法規依從性。

References:
FDAFY 2015 Inspectional Observation Summaries: http://www.fda.gov/ICECI/Inspections/ucm481432.htm#Drugs