The Greatest Management Principle You Never Heard Of

I’ve been in blood banking for over 10 years now and have come to realize that the management principles adopted by the US federal government – yes, the US federal government – yes, our government – are about the best there is.

According to the Food and Drug Administration (FDA), “manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications.”

The FDA’s version of Good Manufacturing Practices (GMP) are so basically simple and obvious that it almost defies description.  Found in the U.S. Code of Federal Regulations (CFR), you know it’s going to be lengthy.

But look past that and pull out the foundations and you’ll see what I’m talking about.

GMPs are part of a quality system covering the manufacture and testing of pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. They’re guidelines that outline the production and testing that can impact the quality of products.  GMP guidelines are not rigid instructions on how to manufacture products.

They’re a series of general principles that have to be observed during manufacturing.  There may be many ways organizations can fulfill GMP requirements. It’s the organizations responsibility to determine the most effective and efficient quality process.

WOW – how often do you hear that when dealing with the government?

What Is And What Should Never Be

What GMP is NOT!

• Short-term successes and rewards.
• Using your old “it still works” equipment until it falls apart because it’s the cheapest way to go.
• Development for high payoff’s and low risks.
• Delivering goods on time “at any cost.”

We live in an “instant, I want it now” culture that sometimes prides itself on having an easy, quick fix for everything. And not surprisingly, this is reflected in our work. We too often reward staff for short-term, patchwork solutions that ultimately create more work and more problems than they solve.

That’s what’s so great about GMPs. They focus on long-term and decisive excellence.

What GMP IS!

• Manufacturing processes that are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
• Manufacturing processes that are controlled and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
• Instructions and procedures written in clear and unambiguous language (called Good Documentation Practices).
• Operators trained to carry out and document procedures.
• Records that are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.
• Records of manufacture (including distribution) that enables the complete history of a batch to be traced that are retained in a comprehensible and accessible form.
• The distribution of the drugs that minimize any risk to their quality.
• A system available for recalling any batch of drug from sale or supply.
• Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures taken with respect to the defective drugs and to prevent recurrence.

Working Better, Not Faster

This may be a completely new thought process to some, but, DO IT RIGHT THE FIRST TIME.  The key to higher productivity lies in working BETTER rather than faster. Working faster and cheaper only allows you to produce the same old defects more efficiently.  Sorry, not the type of efficiency we’re looking for.

“But who can do things right all the time?” High quality and zero defects should be in everyone’s vocabulary.  Find a way.

Here’s a good example. Around the time of WWII, the military discovered that its parachutes failed to open 5% of the time. How do you tell paratroopers going on a mission that, “oh by the way, one out of twenty of the parachutes is not going to open.”?   Problem solved.  Each parachute packer and inspector was required to occasionally put on one of their “products” and jump out of a perfectly good airplane.

Quality quickly jumped from 95% to 100%. Go figure… (hint – ownership).

Anything less than 100% quite often is just not good enough.  Take blood-banking as another example. Look at the following chart and decide what’s “good enough.”

If a lab technician interprets HIV testing on 1 million blood donations:

% of time interpreted correctly	Number of infected patients
99% 99.9% 99.99% 99.999%	10,000 1000 100 10

I seriously believe zero defects would be appropriate here.

FYI – Today, the American blood supply is safer from infectious diseases than it has been at any other time.

The nine points listed earlier outline the things you must do to lead a quality organization. It’s just basic, “why didn’t I think of that”, textbook ideas:

• Control your processes.
• Provide clearly written procedures (SOPs).
• Ensure everyone is properly trained for their role(s) and cultivate a culture of ownership.
• Document, document, document – and keep records accessible.
• Quickly investigate and decisively deal with deviations and complaints.

GMPs should be included as a part of every manager’s philosophy. Because bottom line, when your  products or services are out there, you’ll know, your staff will know, and your customers will know, that what’s being received has been quality controlled and can be trusted every time. And that means easy sleeping for you.

How much lack of quality are you willing to accept? Does your management team require results “at any costs”? How will you go about changing the quality culture in your organization?

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Andy Uskavitch is Leadership Development at Florida Blood Services
He develops and facilitates Leadership, Motivation & Teambuilding Seminars
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