By Rami Azulay, Linoy Shaked
If you and your team are responsible for improving the efficiency and effectiveness of your development lifecycle, quality and compliance in your organization, at some point of your company lifecycle you are likely to face a challenge—getting the support of executives and other collaborating departments in either establishing or expanding an electronic ALM/Quality management system (ALM/QMS).
Most executives observe the high cost of implementing and deploying new technology as the main reason they reject plans to buy software or expand system usage to new areas of quality processes. There are many reasons for interdepartmental resistance to system adoption, but the most common is the lack of understanding of the return of investment (ROI) value of quality.
This white paper is based on a Orcanos group discussion that investigate the underlying factors behind executive and organizational resistance to an electronic quality system. The participants came from regulated companies that use Orcanos QPack ALM for Medical Device software. The discussion was facilitated by Rami Azulay, executive vice president for global sales and marketing, and Linoy Shaked, sales manager for local accounts.
This white paper will reveal the challenges and opportunities experienced by quality and IT professionals when they suggest to switch from a paper-based system to electronic system.
During the research with the group discussion, quality managers expressed the dual problem of how to communicate the advantages of a new or an expanded QMS and how to persuade senior management and the rest of the organization to accept the system.
While there was a wide range of issues discussed, the group narrow down to these common problems they experienced:
Advocating for System Expansion: In one organization, the quality department uses the Orcanos QPack™ system for standard ALM processes such as requirement management and testing management and wants to expand its usage throughout the enterprise. The problem is getting buy-in from the IT department and senior management to support and maintain the system.
Encouraging Another Department to Automate: In one case, the clinical research department is trying to convince another department to switch from a paper-based system to Orcanos QPack DMS™ (Document Control) because of the inefficiency of scanning large amount of records. They also sometimes misplace critical paper documents.
Avoiding a Switch to a New System: A company that has been using Orcanos for many years became a business unit of a global conglomerate. The unit doesn’t want to switch to the parent company’s system, which is inadequate for compliance purposes. The unit must convince the parent company to let it continue using Orcanos QPack ALM Medical System and to consider expanding the system to other business divisions.
Changing Organizational Mindset: Not everyone think quality applied to them, the problem was changing the mindset of other departments that refuse to participate in quality processes.
Five Tips for Getting Buy-In
“Logic and politics don’t align, Most of the time” said Rami Azulay, Orcanos VP Marketing and Sales , a mechanical engineer and computer science master with over a dozen years of experience in the medical device industry. “When we hear Quality professionals who are asking for a Electronic QMS are presenting a common sense problem that can be solved by a common sense solution, they will describe a system with list of features and benefits. But this logical solution doesn’t necessarily aligned with the political situation within the organization.”
Prior to joining Orcanos in 2005, Rami worked in all seniority level roles in the product development, product management, and regulatory compliance in standard ALM firms and medical device firms. He holds the patent for QPack ALM system produced by Orcanos and has successfully launched more than a dozen complex systems involving software hardware and mechanics.
“Over the years, I’ve seen there’s a perception that a QMS is strictly a quality issue for quality people only. When coming to executives and other departments, they don’t feel they are a part of the project or even more how it is related to their success in the existing role they are filling. It’s a problem of misperception,” said Rami Azulay, Orcanos VP Marketing and Sales.
Rami Azulay, who has 20 years of experience in the high tech industry, has served as Senior director manager at global firms such as Comverse and Amdocs Corporation and as manager of applications engineering at Traiana Trading company. His diverse background in engineering, support, and sales gives him a unique approach to customer solutions. He has helped quality and IT professionals gain executive and organizational buy-in for their QMS projects by granting control and governance over company expenses due to lack of quality and un efficient working procedures, keeping the $ in the companies pocket.
At the group discussion, Rami and Linoy shared the following tips:
1. Build Awareness Using Facts and Statistics: Build KPI (Key Performance Indicators) measurements. Document any inefficiencies and quality problems and quantify them, if possible. The fact that your team knows all about the quality issues, might the rest of the organization be in the dark.
Rami state from his experience working with new Orcanos customers where IT Departments dominant strongly and prefer to insist on either using a home-grown system or a certain software. He said, “Our basic assumption when we approach a company is that there is already some legacy system in place. We also consider MS-Office as a system when we talk about quality work. In one of our researched companies, we observed the existing application landscape and we saw how the different departments were siloed. We asked the IT Department how much each of those applications cost and we compared that to the cost of switching to an integrated system like QPack™ QMS.”
Our tip: Cost and dollar figures, thungable hard numbers, and focused information are more convincing than cycling tries in advancing a project proposal.
2. Get Rid of Myth about Quality: Not everyone look and sees quality in the same way, some of your colleagues claim quality doesn’t apply to them, they are safeguarding a myth you must scatter. Everyone is in charge of quality. This is not another idea, but rather you need to advance it proactively.
“At the point when partners who don’t have a quality foundation are gotten, the circumstance can be political. An alternate foundation alone could be the purpose behind their resistance,” Said Linoy
Remind divisions/departments about their part in the broad view of assembling your product/device or giving your service. A definitive objective of everybody is to do his or her part—regardless of how little or circuitous – in verifying your product/device is high quality and free of defects.
3. Comprehend the Needs of Resisting Departments: Quality experts now and then disregard the needs of different offices in their laser like center to get purchase in for a QMS. Rami and Linoy recommended discovering what the needs are of the opposing office. In one organization, demonstrating that it was so natural to utilize Orcanos Process was all it took to win the IT Department’s approbation. “You need to figure out what energizes different divisions,” they included.
4. Locate a Champion: Locate a persuasive individual inside your association to champion your undertaking. Getting the backing of the CEO or an all around regarded senior official will make it simpler to get the support of the rest of the organization, so take a shot at persuading key individuals.
In some cases its not an individual but rather an effective division that can serve as your champion. One member said when the IT Department issued its bolster, it turned into the “voice” of the QMS venture. Persuading other people was less demanding after that.
5. Use Supplemental Tools: There are various tools you can use to support your QMS venture endeavors. You could make a bulletin to assemble attention to your new framework or to clarify the requirement for its development. A consistent pamphlet is a decent approach to assemble client acknowledgement much sooner than you present your new framework.
Orcanos offers tools to help new clients or planned clients advocate for their goal of getting new system, for example, a ROI calculator that will compare the expense of purchasing and keeping up discrete frameworks with the expense of a solitary incorporated framework.
Project leaders can gain from the experience of their companions by going to Orcanos Regional User Group (RUG) occasions such as Orcanos Cafe. They can likewise convey key individuals they are attempting to persuade to a RUG meeting so those individuals can cooperate with fruitful clients.
Orcanos gives references when prospective clients demand them. References would impart their encounters, which could help persuade questioning officials in your association.
Officials regularly dismiss selection of new innovation as a result of the high cost of software licenses versus ROI, yet the circumstance may be improving. A study by Gartner Inc. demonstrated that administrators’ macroeconomic apprehensions have decreased and the greater part of them are more keen on applying innovation forcefully in their organizations in order to gain control and governance to improve efficient.
On the off chance that the overview results are an evidence of better times, quality experts and other innovation backers are in a superior position to propel their QMS ventures with the assistance of the aforementioned tips.
(1) The LinkedIn discussion, titled “Facilitated Group Collaboration: Executive Backing for Expanding QPack,” was held on Dec , 2014, as part of the annual Orcanos Cafe event for Orcanos customers.
(2) The 2014 Gartner CEO and Senior Executive Survey with more than 400 CEOs Gartner is an information technology research and advisory company.
About Orcanos Lאג.
Orcanos produces software solution that empower controlled organizations to get their product to market speedier, while lessening general expenses and expanding inner productivity. Orcanos safely deals with an organization’s discriminating data all through the whole product lifecycle. Our product is known for being anything but difficult to actualize, simple to approve, and simple to utilize. Orcanos technology incorporate quality administration, archive administration, application lifecycle administration, audit management, training management, document control, bill of materials. Supported by a comprehensive array of professional services based on industry best practices, Orcanos provides our customers with a complete information management solution across the enterprise. For more information about QPack, visit www.orcanos.com or call +972-3-537-2561 (Israel);