{"id":368,"date":"2007-02-13T20:36:20","date_gmt":"2007-02-14T01:36:20","guid":{"rendered":"http:\/\/waife.com\/home\/?p=368"},"modified":"2014-02-13T20:36:49","modified_gmt":"2014-02-14T01:36:49","slug":"process-improvement-thats-skin-deep","status":"publish","type":"post","link":"http:\/\/waife.com\/home\/process-improvement-thats-skin-deep\/","title":{"rendered":"Process Improvement That&#8217;s Skin Deep"},"content":{"rendered":"<p><strong>Process Improvement That&#8217;s Skin Deep<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p>Process inefficiency and illogic is rampant throughout our industry \u2013 in every sponsor, CRO and investigative site. There are many relatively quick and effective ways to improve this situation, and they start with awareness.<\/p>\n<p>&nbsp;<\/p>\n<p>Executive readers may protest that their company is well aware of the need for \u201cprocess re-engineering\u201d and that they have already spent millions to do so. Middle managers will groan at more talk about process improvement because they often have been the \u201cvictims\u201d of their executives\u2019 re-engineering projects. The frustration, and lack of impact, that results from these projects comes from the fact that too often, process re-engineering is only \u201cskin deep\u201d.<\/p>\n<p>&nbsp;<\/p>\n<p>Does this scenario sound familiar? A corporation decides to re-engineer their company to develop \u201cbest-in-class practices\u201d. It spends millions on high-level interviews and executive brainstorming which, predictably, produces high level goals like \u201ctriple our pipeline in three years,\u201d or \u201creduce our costs 10% every year for ten years.\u201d Multi-colored laminated diagrams elucidating the workings of interdepartmental teams are distributed company-wide and imprinted on coffee mugs. These goals become the objectives for middle managers to implement and on which their bonuses will be based. Meanwhile the executives congratulate themselves on having re-engineered the company \u2013 they have the wall posters to prove it. The rest is \u201cjust details.\u201d<\/p>\n<p>&nbsp;<\/p>\n<p>Details indeed. How is a department supposed to respond to a dictum stating \u201caccelerating time to market is a key business strategy\u201d? What is a manager to do with a re-engineering recommendation whose specificity is at a level of \u201cregionalization of monitoring resources may be more productive\u201d? The answer for clinical operations managers is having the skills and tools to apply management action and group process to improvement tactics \u2013 to either attack inefficiency or exploit a competitive advantage. The problem is, this is where the money runs out. Corporate leadership is ready to spend millions on the skin cream, but has not been helped to understand the cost of the surgery needed underneath. Even if executives recognize that more detailed work is needed, they find out their discretionary budget has now run dry. So they turn, in time-honored tradition, to middle managers and say: \u201cimplement our Seven Points of Light, and do it while you get your regular work done.\u201d<\/p>\n<p>&nbsp;<\/p>\n<p>Operations managers may have in fact been deeply involved in the re-engineering effort, at least in terms of time spent in interviews, team meetings and exercises. But often they do not see the results of their input translated into a useful operational plan. In this way, managers feel the process improvement was \u201cdone to them\u201d, not for them. The more frequently this happens, the greater the skepticism about process improvement that spreads among all staff.<\/p>\n<p>&nbsp;<\/p>\n<p>This irony is repeated every year across our industry. The more it happens the worse it gets. If left unresolved, the inefficiencies create more financial pressure, which in turn demands more effort from clinical operations groups, who then have even less time to correct the problem. Since clinical development is the longest, most costly period in bringing a new therapy to market, it deserves a more sophisticated, deeper approach to process improvement than it receives.<\/p>\n<p>&nbsp;<\/p>\n<p>What should companies be doing instead? There is certainly strong value in aligning a vast corporate enterprise around a set of clearly defined business strategies, especially for the sprawling merged entities we have in our industry, or for the CROs who have grown far beyond managing by instinct. But once strategies are in place, those who suggest they are bringing value to the corporation through process improvement have to be willing to get their shoes muddy, and need to have the skills to lead the operations group through that mud.<\/p>\n<p>&nbsp;<\/p>\n<p>Clinical operations managers need to anticipate this impact of skin-deep re-engineering and arm themselves with skills and resources to respond, while trying to influence the situation proactively. Here are some suggestions:<\/p>\n<p>&nbsp;<\/p>\n<p>Routinely propose budget dollars and resources for process improvement in your annual plans and defend them aggressively<\/p>\n<p>&nbsp;<\/p>\n<p>Raise the consciousness of the importance of tactics among your bosses and their bosses<\/p>\n<p>&nbsp;<\/p>\n<p>Learn tactical improvement techniques, such as fact-based interviewing and process mapping<\/p>\n<p>&nbsp;<\/p>\n<p>Watch out for re-organization plans based on politics instead of process: organization charts are the language of a corporate persona \u2013 they are too important to be determined by whose job needs to be protected or how to support a manager\u2019s compensation through headcount<\/p>\n<p>&nbsp;<\/p>\n<p>Protect yourself with (and learn from) metrics: measure how you work now so you can see how the imposed changes affect you, for good or ill<\/p>\n<p>&nbsp;<\/p>\n<p>Don\u2019t automate a bad process by trying to help it with technology without understanding the process problems first<\/p>\n<p>&nbsp;<\/p>\n<p>We will write more about these and other techniques in future columns.<\/p>\n<p>&nbsp;<\/p>\n<p>Clinical development is in crisis and superficial re-engineering is not a help. Beauty is only skin deep; process improvement need not be. It is in your hands to make your organization\u2019s inner beauty shine through.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Process Improvement That&#8217;s Skin Deep &nbsp; Process inefficiency and illogic is rampant throughout our industry \u2013 in every sponsor, CRO and investigative site. There are many relatively quick and effective ways to improve this situation, and they start with awareness. &nbsp; Executive readers may protest that their company is well aware of the need for \u201cprocess re-engineering\u201d and that they have already spent millions to do so. Middle managers will groan at more talk about process improvement because they often have been the \u201cvictims\u201d of their executives\u2019 re-engineering projects. The frustration, and lack of impact, that results from these projects comes from the fact that too often, process re-engineering is only \u201cskin deep\u201d. &nbsp; Does this scenario sound familiar? A corporation decides to re-engineer their company to develop \u201cbest-in-class practices\u201d. It spends millions on high-level interviews and executive brainstorming which, predictably, produces high level goals like \u201ctriple our pipeline in three years,\u201d or \u201creduce our costs 10% every year for ten years.\u201d Multi-colored laminated diagrams elucidating the workings of interdepartmental teams are distributed company-wide and imprinted on coffee mugs. These goals become the objectives for middle managers to implement and on which their bonuses will be based. Meanwhile the executives [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[51],"tags":[],"class_list":["post-368","post","type-post","status-publish","format-standard","hentry","category-columns-archive"],"_links":{"self":[{"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/posts\/368","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/comments?post=368"}],"version-history":[{"count":1,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/posts\/368\/revisions"}],"predecessor-version":[{"id":369,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/posts\/368\/revisions\/369"}],"wp:attachment":[{"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/media?parent=368"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/categories?post=368"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/waife.com\/home\/wp-json\/wp\/v2\/tags?post=368"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}