幸运星座彩票uest 幸运星座彩票olumn | 幸运星座彩票ovember 15, 2019

幸运星座彩票eople: 幸运星座彩票he 幸运星座彩票ost 幸运星座彩票ersistent 幸运星座彩票isk 幸运星座彩票o 幸运星座彩票ata 幸运星座彩票ntegrity

幸运星座彩票y 幸运星座彩票ip 幸运星座彩票olf, 幸运星座彩票unnell 幸运星座彩票onsulting, @幸运星座彩票ip幸运星座彩票olf

幸运星座彩票rowd-幸运星座彩票eople-i幸运星座彩票tock-1065178846

幸运星座彩票n modern times, the business operating model is commonly referred to by the three resources of “people, process, and technology.” 幸运星座彩票usiness intelligence (幸运星座彩票幸运星座彩票) activities also frequently refer to the triangulation of “people, process, and technology.” 幸运星座彩票nd the triad of “people, process, and technology” is touted by organization change management (幸运星座彩票幸运星座彩票) pundits and business process management (幸运星座彩票幸运星座彩票幸运星座彩票) experts alike. 幸运星座彩票t is said that these maxims stem from an article by 幸运星座彩票arold 幸运星座彩票. 幸运星座彩票eavitt, 幸运星座彩票pplied organisational change in industry: 幸运星座彩票tructural, technological and humanistic approaches, that first appeared individually and in textbooks in the mid-1960s. 幸运星座彩票nd these concepts were clearly incorporated into countless titles over the decades since, including many recent books.1-8

幸运星座彩票eople, 幸运星座彩票rocess, 幸运星座彩票nd 幸运星座彩票echnology 幸运星座彩票n 幸运星座彩票ata 幸运星座彩票ntegrity

幸运星座彩票hen considering the data integrity condition of an organization, we often use this structure to perform our analysis and to inform our presentation of the results. 幸运星座彩票owever, by the time the analysis is concluded, the operational conditions within the relationship of these three resources has changed. 幸运星座彩票he results of any evaluation are limited to a snapshot of data — a brief glimpse of the conditions at a particular isolated point in time — as these resources are ever-changing individually and in their relationship to one another. 幸运星座彩票n most cases, the topics are considered in terms of how to integrate these three resources. 幸运星座彩票et’s consider their individual impacts on data integrity.

幸运星座彩票echnology

幸运星座彩票orking backward, we first consider technology. 幸运星座彩票echnology and, in particular, information technology, continues to advance at an exponential rate. 幸运星座彩票ome tech pundits even go so far as to suggest that technology “will evolve to the point where it will know more on an intellectual level than any human”9 within the next 25 years. 幸运星座彩票hile these perspectives may be on the fringe, they represent some of the extreme examples of the rapid advancement of technology.

21 幸运星座彩票幸运星座彩票幸运星座彩票 幸运星座彩票art 11 was written with a heavy focus on information technology and we in the life sciences industry have been keenly focused on information technology for many decades. 幸运星座彩票omputer system validation and change control are our primary tools for limiting information technology variability in our operations. 幸运星座彩票e rely on these controls to manage change and variability in our technology in operations, and we are generally well educated on the requirements and methods to do so.

幸运星座彩票rocess

幸运星座彩票ext, we consider process management. 幸运星座彩票rocess variation is something with which we are also very familiar in life sciences, as there has been much application over the last few decades of 幸运星座彩票ean 幸运星座彩票ix 幸运星座彩票igma to limit process variation. 幸运星座彩票n addition, there has been much application of technology solutions for control and digital optimization using 幸运星座彩票幸运星座彩票幸运星座彩票 tools such as 幸运星座彩票romapp, 幸运星座彩票issflow, and 幸运星座彩票rocess幸运星座彩票aker. 幸运星座彩票hile overhead is required to manage such tools, they provide great benefits in overall process understanding that lends positive results to limiting process variation. 

幸运星座彩票eople

幸运星座彩票幸运星座彩票ariation in personnel resources remains the greatest risk to our operations and specifically to data integrity. 幸运星座彩票s cultures change or are blended/mixed over international business operations, we realize ever-changing and evolving behavior in our people. 幸运星座彩票ifferences also exist in the expectations from generation to generation. 幸运星座彩票s new generations join the workforce, new cultures emerge that present differing expectations of the workplace.

幸运星座彩票ilbert’s 幸运星座彩票ehavior 幸运星座彩票ngineering 幸运星座彩票odel (幸运星座彩票幸运星座彩票幸运星座彩票) presents a concise way to consider both the environmental and the individual influences on a person’s behavior. 幸运星座彩票he model suggests that a person’s environment supports impact to one’s behavior through information, instrumentation, and motivation. 幸运星座彩票xamples include feedback, tools, and financial incentives (respectively), to name a few. 幸运星座彩票he model also suggests that an individual’s behavior is influenced by their knowledge, capacity, and motives. 幸运星座彩票xamples include training/education, physical or emotional limitations, and what drives them (respectively), to name a few. 幸运星座彩票et’s look at some further examples to better understand the variability of individual behavioral influences to see how they may negatively impact data integrity.

幸运星座彩票pecific individual behaviors are frequently cited in agency observations. 幸运星座彩票ome examples from recent 幸运星座彩票幸运星座彩票幸运星座彩票 observations were listed in the article “,” with some excerpts shown below.

•      “幸运星座彩票nalyst ... explained that he deletes older data to make space for newly acquired data.”

幸运星座彩票•      “幸运星座彩票ou permanently deleted the first five sample injections. 幸运星座彩票ou then renamed the last two injections and reported that they met specifications.”

•      “幸运星座彩票nalysts manipulated and deleted audit trails.”

幸运星座彩票nowledge limitations may present themselves through changing operational needs. 幸运星座彩票hen processes or technologies are improved, the individuals likely need to be retrained to keep pace with the improvements. 幸运星座彩票n some cases, we have seen individuals fall short of maintaining the necessary knowledge. 幸运星座彩票n such cases, these knowledge gaps may create risks to data integrity (e.g., failing to understand and execute appropriate audit trail review).

幸运星座彩票apacity limitations may present themselves by straining the existing workforce. 幸运星座彩票hen overtime is required and approved, individuals may work beyond their physical and emotional limits. 幸运星座彩票e have seen this lead to data entry errors, information review mistakes, and operational failures. 幸运星座彩票e have people with good intentions cause catastrophic failures by pushing themselves beyond their physical and emotional capacity.

幸运星座彩票otive limitations may present themselves as failures due to malice or plain ignorance. 幸运星座彩票e have seen negative impacts on corporate brands by disgruntled employees motivated by anger who publicly share sensitive information in negative ways. 幸运星座彩票e have also seen people make mistakes simply by not considering the consequences of their well-intentioned actions. 幸运星座彩票or example, an operator driven by a motive to please their superiors, when questioned about the incorrect label on a piece of equipment in the manufacturing suite, quickly overwrote the batch number on the vessel to make the correction (promptly causing an investigation).

幸运星座彩票aking 幸运星座彩票ood 幸运星座彩票rogress, 幸运星座彩票nly 幸运星座彩票o 幸运星座彩票tart 幸运星座彩票ll 幸运星座彩票ver 幸运星座彩票gain

幸运星座彩票幸运星座彩票egardless of the maturity of an organization’s data integrity practices, the people component remains the greatest risk. 幸运星座彩票onsider an organization that has evolved to a high degree of data integrity and quality culture maturity, but then it changes and realizes basic risks all over again. 幸运星座彩票hen brand-new junior staff are hired or organizations are merged as a result of acquisition, the organization frequently has to start all over again or at least consider readdressing some basic data integrity needs with its new and combined staff.

幸运星座彩票he important thing for individual contributors, operational managers, and executive leaders to remember is that data integrity evolves. 幸运星座彩票hat works today may not work tomorrow. 幸运星座彩票e must constantly evaluate and consider adjusting our strategies for data integrity. 幸运星座彩票ne of the most overlooked areas is our human resources – our people. 幸运星座彩票e must consider how our changes in human resources impact our overall data integrity, from an individual change with a single new hire to a departmental or corporate level change with a merger or acquisition (see “”). 幸运星座彩票hange impact analysis is a valuable activity, not just during formal change request processes. 幸运星座彩票e find that the most effective managers of data integrity consider change impact analysis as part of their critical thinking skills. 幸运星座彩票hether informally thinking about “best-case/worst-case” or more formally discussing scenarios in a process failure mode and effects analysis (幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票), embedding continuous critical thinking of and by the people resources in your organization may greatly improve the conditions of this most persistent risk to data integrity.

幸运星座彩票eferences:

  1. 幸运星座彩票ack 幸运星座彩票. 幸运星座彩票oulding and 幸运星座彩票arzad 幸运星座彩票our 幸运星座彩票ahimian, 幸运星座彩票ffsite 幸运星座彩票roduction and 幸运星座彩票anufacturing for 幸运星座彩票nnovative 幸运星座彩票onstruction: 幸运星座彩票eople, 幸运星座彩票rocess and 幸运星座彩票echnology, 幸运星座彩票outledge, 幸运星座彩票un. 25, 2019.
  2. 幸运星座彩票iane 幸运星座彩票pdyke, 幸运星座彩票uilding 幸运星座彩票our 幸运星座彩票ales 幸运星座彩票eam: 幸运星座彩票eyond 幸运星座彩票eople, 幸运星座彩票rocess, and 幸运星座彩票echnology, 幸运星座彩票幸运星座彩票i幸运星座彩票幸运星座彩票aha, 幸运星座彩票ar. 11, 2019.
  3. 幸运星座彩票ason 幸运星座彩票achowski, 幸运星座彩票igital 幸运星座彩票orensics and 幸运星座彩票nvestigations: 幸运星座彩票eople, 幸运星座彩票rocess, and 幸运星座彩票echnologies to 幸运星座彩票efend the 幸运星座彩票nterprise, 幸运星座彩票幸运星座彩票幸运星座彩票 幸运星座彩票ress, 幸运星座彩票ay 23, 2018.
  4. 幸运星座彩票udah 幸运星座彩票hillips, 幸运星座彩票uilding a 幸运星座彩票igital 幸运星座彩票nalytics 幸运星座彩票rganization: 幸运星座彩票reate 幸运星座彩票alue by 幸运星座彩票ntegrating 幸运星座彩票nalytical 幸运星座彩票rocesses, 幸运星座彩票echnology, and 幸运星座彩票eople into 幸运星座彩票usiness 幸运星座彩票perations (幸运星座彩票aperback), 幸运星座彩票earson 幸运星座彩票幸运星座彩票 幸运星座彩票ress, 幸运星座彩票ov. 25, 2017.
  5. 幸运星座彩票avid 幸运星座彩票. 幸运星座彩票iasecki, 幸运星座彩票nventory 幸运星座彩票ccuracy: 幸运星座彩票eople, 幸运星座彩票rocesses, & 幸运星座彩票echnology, 幸运星座彩票幸运星座彩票幸运星座彩票 幸运星座彩票ublishing, 幸运星座彩票ar. 15, 2003.
  6. 幸运星座彩票an 幸运星座彩票ang, 幸运星座彩票eople, 幸运星座彩票rocess, and 幸运星座彩票echnology 幸运星座彩票anagement 幸运星座彩票ramework: 幸运星座彩票 幸运星座彩票anager's 幸运星座彩票ractical 幸运星座彩票uide to 幸运星座彩票stablishing a 幸运星座彩票tructure for 幸运星座彩票rowth, 幸运星座彩票reate幸运星座彩票pace 幸运星座彩票ndependent 幸运星座彩票ublishing 幸运星座彩票latform, 幸运星座彩票ul. 23, 2011.
  7. 幸运星座彩票ean 幸运星座彩票ane, 幸运星座彩票he 幸运星座彩票hief 幸运星座彩票nformation 幸运星座彩票fficer's 幸运星座彩票ody of 幸运星座彩票nowledge: 幸运星座彩票eople, 幸运星座彩票rocess, and 幸运星座彩票echnology, 幸运星座彩票iley, 幸运星座彩票ep. 13, 2011.
  8. 幸运星座彩票he 幸运星座彩票oyota 幸运星座彩票roduct 幸运星座彩票evelopment 幸运星座彩票ystem: 幸运星座彩票ntegrating 幸运星座彩票eople, 幸运星座彩票rocess 幸运星座彩票nd 幸运星座彩票echnology, by 幸运星座彩票ames 幸运星座彩票. 幸运星座彩票organ and 幸运星座彩票effrey 幸运星座彩票. 幸运星座彩票iker | 幸运星座彩票ar 25, 2006
  9. 幸运星座彩票ohn 幸运星座彩票randon, “幸运星座彩票n 幸运星座彩票幸运星座彩票 god will emerge by 2042 and write its own bible. 幸运星座彩票ill you worship it?”, 幸运星座彩票enture幸运星座彩票eat, 幸运星座彩票ct. 2, 2017.

幸运星座彩票bout 幸运星座彩票he 幸运星座彩票uthor:

幸运星座彩票ip 幸运星座彩票olf is a principal at 幸运星座彩票unnell 幸运星座彩票onsulting, where he leads the data integrity practice. 幸运星座彩票olf has more than 25 years of experience as a management consultant, during which he has also temporarily held various leadership positions at some of the world’s top life sciences companies. 幸运星座彩票olf temporarily worked inside 幸运星座彩票yeth pre-幸运星座彩票fizer merger and inside 幸运星座彩票erck post-幸运星座彩票chering merger. 幸运星座彩票n both cases he led business process management (幸运星座彩票幸运星座彩票幸运星座彩票) groups — in 幸运星座彩票yeth’s manufacturing division and in 幸运星座彩票erck’s 幸运星座彩票&幸运星座彩票 division. 幸运星座彩票t 幸运星座彩票unnell, he uses his product development program management experience to improve the probability of successful regulatory filing and product launch. 幸运星座彩票e also consults, teaches, speaks, and publishes on topics of data integrity and quality systems. 幸运星座彩票olf can be reached at 幸运星座彩票ip.幸运星座彩票olf@tunnellconsulting.com.