Archive for October, 2013

Negativity? Call it out!

October 31, 2013 1 comment

I was a panelist as a recent leadership conference in Baltimore, and was asked the following question. A perpetually negative team member can suck the life out of an entire team. How do you correct or counteract the negativity?

This is the process we teach our front-line leaders:

  1. Call it: Don’t fool around; give the candid feedback.
  2. Ask, listen: Get the person talking. Start by asking the dumb question: what is the real problem? Then listen, and listen aggressively . This person is negative for a reason. It’s your job to find out where the negativity is coming from. 
  3. Respond: First response: the negative behavior stops now. Say it just like that. Then you can figure out if you’re going to solve their problem or not. It’s OK if sometimes you’re not going to fix it; some problems are beyond your scope. Either way, tell them what is going to happen.
  4. If this doesn’t work: Get them off the team. Fix it or remove it, but do not tolerate toxic behavior in the group.

You have to move fast: This stuff can get so out of hand so quickly; you’ll have unholy bedlam on your hands if you don’t sort it out today. The sequence is important too. If you respond with expectations before you know the root cause, you’ll misdiagnosis the real problem.

This process requires that you speak with complete clarity and honesty, that you listen aggressively, and that you move with strong resolve. But don’t worry; you already do all that anyway.


First, master the message

October 29, 2013 Leave a comment

I’m often told by my cohort that communication isn’t what it used to be. The Luddites would have me believe face-to-face is dead and replaced by electrons. Far from it! Face-to-face will never go out of style; it’s just supplemented by email, IM, texting, Skype, Twitter, and other media

Continuous connectivity is a fact, and any leader worth their salt seeks out a way to master that context. Here are a couple of pointers I share with all my front-line staff:

  • First master the message
    • No amount of technology can fix a bad message. Regardless of the vehicle, you still have to craft and sell the message.
    • That fundamental has not changed and never will: An effective message is born from meticulous craftsmanship, and the way we craft a message has not changed in spite of all the technology.
  • Then master the volume
    • You can’t ignore it and you can’t make it go away. I get 120 – 150 email/day, 100’s of tweets, a dozen or so blogs, RSS feeds, etc.
    • Data filtering is a critical leadership skill. It’s about signal vs. noise: know the difference and assume a substantial amount of the input is noise. Your job is to figure out what is true signal.
    • Don’t respond to everything, only respond to signal.
    • My front line supervisors learn from day one that (important + urgent) = mandatory live interaction.

And don’t worry about the technology. If you master the message and master the volume, then the technology will sort itself out.

Dock to Stock

October 25, 2013 Leave a comment

Suspension of acceptance inspections, or “Dock-to-Stock (DTS)”, is a common practice in a wide variety of industries, including aerospace, pharmaceutical, biopharma, and medical device industries. Properly applied, a DTS strategy can improve operational responsiveness and provide considerable cost savings. The decision to suspend incoming inspections is not a trivial matter, and companies cannot simply “decide” to implement a DTS policy without considering the potential risks and how those risks may be mitigated. Suspension of inspection is predicated on the following assumptions:

1. The intrinsic risk to customers is already low.

2. Potential risk to the customer has been minimized by redundant and robust quality systems.

3. The extant quality history of the component and/or supplier demonstrates acceptable and consistent performance levels.

4. The cost benefit is positive.

The DTS status of a given component represents one point in the continuum of product acceptance activities.  


Supplier selection      >     100% inspection        >      Sampling plans        >        Dock-to-stock (DTS)


The current acceptance activities for any component may change as the quality history of that component evolves.

Outsourcing Quality Assurance

October 23, 2013 Leave a comment

One of my colleagues in the pharma industry asked a question the other day if Quality Assurance could be outsourced. Here’s the answer:

“This is an acceptable practice, and has precedent in the pharma/biotech industry. It must be managed and controlled like any outsourced process as described in ICH Q10. Pretty much everything can be outsourced except Management Responsibilities (again, an ICHQ10 requirement). This is how virtual companies, integrators, and specification developers often run their QA. Don’t believe that outsourcing QA will protect the Management team: Management still has overall responsibility for quality outcomes, including quality of product on the market. Think of the European model of Qualified Persons; they often act on an independent contract basis. A strong quality/technical agreement that describes the scope, responsibilities, and oversights how this outsourced process is managed would be the first step in outsourcing QA.”

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