Getting the right people involved in Kaizen Events

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A kaizen event is a focused, short-term project that improves a process.  But like any project, regardless of the duration, you should always use good project management principles to lead your team to success.  One of the first steps is to identify who should participate on the team…

I had a recent conversation with a project sponsor of a kaizen event and they expressed their concern over the amount of action items that were being delegated to team members.  It left very little time for people to do their core job and added to everyone’s frustration level.

Further into the conversation you realized that process owners and stakeholders hadn’t been correctly identified, so there was a big disconnect between the people that should be attending the events versus who was actually attending.

People that were assigned actions, would spend time afterwards searching for the right person to give the action to. Here’s the kicker, the original person that was assigned the action was still responsible for reporting the status of that action…that meant they had to run around before every meeting to find out the status.

It’s at this point of the conversation I wanted to scream ‘stop the insanity’, because the event leader had created a non-value added role of the middleman to report status updates.  It turns out the project sponsor also didn’t know who the process owner or stakeholders were because roles and responsibilities had never been clearly defined.

Unfortunately, after  less than one year, kaizen events had become synonymous to something negative.  The lesson here is to always follow good project management practices, which includes identifying the right process owner and key stakeholders.  If none can be identified or it’s unclear, then you have your first kaizen event…defining roles and responsibilities of that process!

Photo by Luigi Diamanti @ Freedigitalphotos.net

Just wanted to make you aware of a new resource that’ll be available to you and your organization soon..

After the new year, I plan on offering Online Workshops. Right now you can add your name to a list to get notified when more information is available.

If you’re on the list, you’ll also be first in line to enroll in the workshops…read more

Quality Assurance Training/Online Workshops Coming Soon
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Photo by Rasmus Thomsen @ Freedigitalphotos.net

I’m thinking about offering Quality Assurance training in the form of online workshops.  Initially, I want to focus on nonconformance and corrective action, and would like to expand the workshops to include other topics.

If I decide to move forward, I’d like to consider some of the issues that you’re currently dealing with, specific to nonconformance and corrective action.

Now’s your time to speak up and share your pain in the form of a comment or you can contact me through the contact page.

I’m sure you’ve had this happen before, where an auditor (internal or external) has cited you with a finding, 483, or an observation that you quickly addressed by adding a line or two of information to a particular Standard Operating Procedure (SOP)…that was easy.

But then you go through another audit and find yourself making more changes to the same SOP.  Within a couple of years, that one SOP could have gone through several revisions as a result of audit responses…especially if it’s a global procedure.

What you may not realize is that over time, the SOP slowly becomes misaligned from a process perspective when you add or delete information without evaluating the entire SOP.  Any misalignment will make it difficult for staff to follow or even understand.  Next thing you know, the procedure is associated with several nonconformances.

Additionally, a simple change to one SOP may impact other SOP’s, so it’s important that you understand the relationship between procedures and the processes they govern.  An example would be your noncnformance (NC) and corrective and preventive action (CAPA) process.

Let’s say you made changes to your nonconformance SOP that required all investigations to have a CAPA assigned to them.  Had you read the CAPA procedure, you’d realize that only nonconformances that pose moderate to severe risk must have a CAPA.

Which requirements are people supposed to follow since the two SOP’s have conflicting information?  And what about your response to an auditor that questioned why some investigations didn’t have a CAPA assigned to them?  And lastly, how many nonconformances were a result of this oversight?

In the end, your good intentions of addressing an audit finding by quickly revising an SOP may result in more problems.  The next time you’re asked to add a line or two to an SOP, follow these guidelines, then proceed with confidence!

1. Always access the entire SOP before making changes. This will help you identify confusing language or potential conflicts within the procedure itself…make sure the process within the SOP makes sense!
2. Identify other SOP’s that may be impacted by the changes and revise as necessary. This can be simply done by understanding the relationships between processes.

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On occasion, I’ll get an email from a Quality professional expressing their frustrations with the profession…specifically, work cultures that show little respect or commitment to Quality.  The frustrations can be so overwhelming that you may feel like quitting your job and changing your career path to include anything but Quality.

Before you quit, you need to realize that you’re more marketable to a prospective employer if you’re actively employed, so it’s best to come up with an exit strategy that will allow you to go from one job to another.  After all, not everyone that quits their job will get a reality show like Stephen Slater, the Jetblue flight attendant that quit after a bad day at work.

After years of working both in regulated and non-regulated industries, I can tell you this….on average, there’s much more commitment to Quality in a regulated industry hands down!  It’s because the stakes are much higher if a company doesn’t comply with requirements imposed by a regulatory body.  For example, the FDA has the authority to enforce requirements, if necessary, by taking actions such as: Seizures, injunctions, criminal prosecutions, etc.

ISO has no such power or authority.  The most your ISO registrar can do is take away your certification, but they can’t impose fines or shut your business down.  So before you throw in the towel and quit the Quality profession, consider working in a regulated industry where Quality is recognized as a necessary and important part of the business and not just as unwelcome overhead.

How to Cope with Frustrations at Work (Serenity Now!)

• Take a  ‘cigarette’ break, even if you don’t smoke.  Just being away from your desk and in the fresh air can give you a new perspective.
• Have lunch off site once a week. Brown bag it and sit at a local park or in your car if you’re pressed for time.
• Drive to a local Dunkin Donuts for a cup of coffee. It seems like there’s one on every city block, so you wouldn’t be gone long if you got your coffee to go.
• Prioritize the importance of your job as it relates to your family and life in general.  Chances are your family will be number one and not your job.  Now put your frustrations into perspective…I’m betting that you’ll realize in the scope of life, your work frustrations are inconsequential.
• Wear headsets at your desk and listen to music that has a calming effect on you…while you’re working of course.
• Take the scenic way home from work. This will give you time to unwind and not bring your frustrations home where it can upset more than just you.
• Find your mental ‘happy place’. Maybe it’s imagining you’re at the beach or relaxing on a hammock that makes you feel the happiest.  Go to your metal happy place whenever you get frustrated to help you get re-centered rather than letting your frustrations build up.

How to Break Into a Regulated Industry

• Approach small local companies about working a few hours a week on your personal time so you can gain experience.  Want the small company to take you up on your offer quickly?  Volunteer your time.
• Take a few professional development courses that are specific to the regulated industry that you’re targeting so you can put it on your resume.
• Join industry specific forums online. Linkedin (www.linkedin.com) has a lot of forum groups that you can join…this is where you’ll find the unadvertised jobs or get to know people that can open a few doors for you.
• Put industry buzz words on your resume. To find out what the buzz words are, look up job postings on any online job board (Monster.com, CareerBuilder.com, etc.) and the buzz words will be embedded in the job description.
• Go to your local library, where you can look up companies by industry and geographical location.  Most libraries have a collection of resource books that list all manufacturers in the U.S….they look like old fashioned encyclopedias.  The book will also let you know the size of the company and who it’s leaders are, which is great for addressing your resume to a specific person.

Examples of Regulated Industries to Get You Thinking…

• Energy (Nuclear) (NRC – Nuclear Regulatory Commission)
• Medical Device (FDA – Food and Drug Administration)
• Cosmetics (FDA)
• Blood (FDA)
• Biologics (FDA)
• Pharmaceuticals (FDA)
• Food (FDA)
• Aerospace (FAA – Federal Aviation Administration)
• Environmental (EPA – Environmental Protection Agency)

Start developing your exit strategy today, so you can transition to a regulated industry that takes Quality seriously.    By actively working on your strategy, you’ll feel less frustrated and more in control of your career direction.

Time To Think Out Of The Box… by Frits Ahlefeldt

In the past Quality has always played a support role in most organizations, but if you look closely that role is slowly changing to one that’s more strategic.

A good example is the biotech industry, where you’ll occasionally see start-up companies bring in Quality Engineers and continuous improvement methodologies at the onset of their business so they can prevent defects instead of just detecting them…a more proactive approach.

Although change can be slow, the current economic pressures are forcing companies to ‘think outside of the box’.  This is where you step in and educate your leaders on the value of practicing strategic Quality.

Industry Week recently published a series of three short articles about the benefits of strategic Quality Management that includes the involvement of your customer, everyone in your organization, and risk management.

Use these articles to engage your leaders in a discussion about Quality’s role.  Don’t forget to quantify the financial value…talk money, and you’ll almost always get management’s attention.

Part 1 - Rebalancing Quality Priorities
Learn the benefits of better quality and how your organization can achieve it.

Part 2 – Quality Equals Risk Management
Find out how susceptible your organization is to a quality crisis.

Part 3 – Transforming Quality Culture
Learn the four success factors that your organization must have in place to create excitement, inspiration, and empowerment regarding quality.

Photo by Petr Kratochvil @ PublicDomainPictures.net

After watching an episode of Undercover Boss last week, I was reminded of how ineffective employee performance reviews really were.

The show is about high-ranking officials that go undercover to see the inner workings of their company by pretending to be an employee.  The undercover boss usually finds a few standout employees that are hardworking with a positive attitude…and yes, there’s the occasional bad apple.

At the end of the show when the boss reveals their true identify, s/he usually rewards the good employees with money and a promotion, and the bad ones are reprimanded and given the opportunity to redeem themselves (at least that’s on camera).

Here’s the question that I have…after working several years for a company, how is it possible that a standout employee not get noticed, while bad apples remain employed?  Why didn’t the performance reviews weed out the good employees from the bad, especially since feedback from others are incorporated into the reviews?

From my own experience, your performance is always jaded by your bosses perception of you.  If your boss doesn’t like you, then even if you cure cancer and world hunger, you’re probably not going to get a great review.  But there are ways that you can protect yourself so you can get at least a decent review…think of it as personal risk management.

• Make sure your goals are measurable and aren’t vague concepts, such as ‘just get over the finish line.’
• If your goals change throughout the year, document the changes.
• If your goals are unattainable because of forces outside of your control, let your boss know immediately.  For example, if you’re required to attend a training class as one of your goals, but it’s been canceled due to low enrollment, talk to your boss about an alternative course…and document the approved change.
• If your boss keeps piling on the goals throughout the year, have a discussion around which goal(s) can be eliminated or transferred…at the very least, get your boss to prioritize your goals
• Whenever you have a satisfied internal or external customer, encourage them to send an email to your boss praising you.

If you arm yourself with enough data, you can protect yourself against a poor review or even worse, a layoff or firing.  Also, with a good review you have a better chance of transferring to another department with a manager that has a reputation of being fair.

Getting back to the show, it was nice to see people recognized for their hard work and positive attitude.  Thanks to CBS the good guys won and the bad guy ultimately quit after the show aired.  Once the glitz and glamour of Hollywood fade, the boss still needs to investigate the underlying problem of detecting good vs. bad employees within their organization.  But they should also question the value of the performance review process or at the very least improve it.

Leader And The Team by Petr Kratochvil

If you think personality types don’t matter, then think again.  As a Quality professional, there’s been many times throughout my career that I had to lead a project team.

On one occasion, I can remember working with a team to create a process map, which was just one of many tasks we had to deliver. I wasn’t involved in the team selection, since that was the responsibility of the project sponsor.

At our first working meeting, I decided to create an interactive environment where everyone would get out of their seats and create the process map on kraft paper that was taped to the wall. This would give everyone the chance to actively participate and engage in discussion.

The team was so reluctant to participate.  I had to keep reminding them to move around and not just stand in one place (which was next to their chairs).  At times I was forced to poke the team to see if they were still breathing!  Needless to say, the meeting didn’t go very well.  I was disappointed at how little we got accomplished in that one hour.

Out of concern, I called in a co-worker and good friend to help facilitate the next session…he was a very seasoned project manager.  At the end of another one hour session, he got about as much information out of the team as I had…the kraft paper on the wall was pretty sparse.  His words of wisdom were ‘good luck with that team kiddo’, which didn’t exactly make me feel good.

I had already used up two weeks of the project timeline and didn’t have much to show for it. Instead of attempting a third try at building a process map, I decided to take a step back and analyze the situation to understand why the team was barely participating.  I then realized the project sponsor had selected highly qualified people that were knowledgeable on the process, but they were all introverts being led by an extreme extravert!

I had to quickly change my approach as to how to lead the team so that I could complete the project on time.  After that day, I had made it a standing rule to work with project sponsors on the importance of identifying personality types before selecting team members.  After all, too many extraverts can also slow down a project because we all want to talk.

The next project that you lead, take the time to educate the sponsor so you can be sure your team has a good balance of different personality types…have them use the results of personality tests their employees may have taken in the past (Meyers-Briggs, DISC).

You know that dreaded feeling, when you realize that you forgot to put key information in a non conformance report that’s since closed and product has been released?  Do you reopen the report or not bother?

Every time you reopen a closed non conformance report, you’re putting your company at risk from a compliance and maybe even a liability perspective.  That’s because an auditor would begin to question the integrity and thoroughness of the investigation.  S/he would want to know, was the investigation cut short because the focus was on releasing product and not finding root cause? If the missing information were available at the time of the investigation, would the product still have been released?  And if you’re FDA regulated, did you put patients at risk because non conforming product may have been released?

Once an auditor questions the integrity of an investigation, all investigations are then questioned and they’ll start looking for trends to support their suspicions…it’s like opening pandora’s box! And keep in mind that if you have an electronic system, the audit trail will document when and how often a record was opened, and what information was added, so it’s even more obvious to a savvy auditor.

To minimize your risk, you’ll first need to know how often records have been reopened in the past.  If you have an electronic system, then you should be able to quickly run a report.  For paper systems, you’ll unfortunately have to manually look through each report.  Any reopened records found will have to be re-evaluated through the eyes of an auditor to determine the severity of the situation.

For example, was the record reopened to fix grammar and typo errors or were lot numbers affected by the non conformance not included in the initial investigation?  Either way, you’ll need to know how you’ll handle the situation should an auditor ask questions.  Moving forward, you should consider how you’ll control the reopening of closed non conformance reports and write a procedure documenting the control…this applies even to companies that provide a service as opposed to a manufactured product.

Photo: Bright Idea by Zaldy Icaonapo

I recently came across an article that outlines 23 reasons why most brainstorming sessions fail. The information in the article can be used as a checklist to help you avoid the most common pitfalls, or at the very least be aware of them.

Be sure to read the comments at the end of the article, since they offer more insight that can be added to your checklist (giving you 23+ reasons).

Here’s the link to the article:  23 Reasons Why Nothing Happens After a Brainstorming Session