#116 – WHAT QUALITY REALLY MEANS? – LANE HIRNING

AAA HIRNINGA friend of mine recently asked me to review his PowerPoint presentation for an upcoming investor conference, which I was happy to do. The first thing that struck me was his choice of fonts—different types and different colors. Second was the slide templates creating an inconsistent layout. It seemed like a trivial thing to point out, but I had to ask him: What kind of a first impression are you going to make with this presentation?

As a member of the product management team for a software provider that caters to regulated industries, I’m keenly aware of the importance of quality and how it impacts our customers. If you are a quality professional yourself, or if you belong to a regulated industry, then you’ll understand when I say that for us, quality is a way of life. It’s not something like a hat, which you put on in the morning before you leave the house and then take off in the evening when you come home.

 

My friend is not in the same field; he’s an entrepreneur working with consultants. He’s trying to get investors to finance his business and hired consultants to help him create a strong presentation, but it resulted in a case of too many cooks. I explained to him that if his fonts looked like they were in a riot, then it could make potential investors wonder what his invention and financial records looked like. Once it was pointed out, he became very conscious of the quality of the presentation and the impression it would make to investors.

Regardless of field, the concept of quality is crucial. If you’re in manufacturing, it might mean making sure your team members wear protective clothing and gloves each and every time they enter the cleanroom so as not to jeopardize a product’s sterility. If you’re in marketing, it could mean sticking to a simple logo that will be used across all of your promotional campaigns to reinforce branding. And yes, if you’re a small business, it could be as simple as choosing a single type of font and slide layout for a presentation.

3 Quality Principles

To help my friend and anyone who is aiming for high quality, I came up with these basic principles that I, myself, keep in mind in everything I do:

#1 Be consistent. This is the essence of standardization for regulated companies—from organizational policies to work instructions and SOPs to quality manuals. There is inherent value in procedures that are the same for everybody and can be repeated with assurance that they will yield the same high-quality results. For life science companies, making sure documents are up to date and keeping consistent training records can make or break you in FDA audits. For small and medium companies, keeping all of your records consistent and timely can also make your company more valuable in this era of widespread mergers and acquisitions. Sometimes, like in my friend’s case, the “too many cooks” rule can apply—having multiple editors or systems can remove consistency

#2 Be mindful of your quality message. Your organization reflects your message in big ways, such as gaining FDA approval for a new medicine or passing an annual customer audit, and in small ways, such as keeping your facilities clean and requiring all employees to dress in business attire at all times. You could say that you embody your organization’s quality message. What kind of impression are you giving when you talk to an auditor or a customer? How about your presentations?

#3 The devil is in the details. Going back to my friend’s example, the data in his PowerPoint presentation may be impressive, but if the potential investors are too distracted by the crazy fonts, they will miss what’s really important. And if they are distracted, it’s unlikely for them to give my friend a second chance. The big picture is important, but don’t forget the little details that make up the broad strokes.

In his case, the realization that attention to details was important seemed to have done the trick. He is now in discussions with a number of large investment groups to find a partner to bring his product to market. Interest in his product had been lacking prior to that investor presentation. A key lesson here is—quality shines through.

(Note: This article is used with permission from GxP Lifeline and has been previously published at www.mastercontrol.com

Lane Hirning is a pharmacologist with extensive IT experience in the pharmaceutical industry. He’s a product management director and also a technical product manager at MasterControl. He specializes in product development for the pharmaceutical, blood, and biologics industries, especially large-tier companies. He began his career as a research scientist at NPS Pharmaceuticals Inc. for seven years. He then went on to serve various roles as an IT executive for 12 years. He joined MasterControl in 2006.

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