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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.

We’ve all heard it before, co-workers referring to Quality Assurance as the ‘police’ .  With such an unflattering label, it’s no wonder people avoid us (from an on-the-job point of view).  It makes me wonder how much responsibility we bear for the negative perception of Quality.

I remember working on a Quality project with several people that I had never worked with in the past.  Being the project leader, I would get into the habit of chasing people down when their task was past due and they hadn’t shown up at the recent status meeting…I had a timeline to meet.  I would call the person, but as expected, I would get their voicemail and they never seemed to be in their office (I swear someone would tip them off that I was coming).

So one day I tried an experiment.  I called this person on another phone so the caller ID would flash a different name other than mine.  You guessed it!  They answered on the first ring and you could hear the dread in their voice when they realized it was me….I didn’t take it personally .  I realized at that moment that I had conditioned this person into thinking that anytime I called, it only meant one thing….that I wanted something from them.  From their perspective, my presence was negative because I hadn’t taken the time to build a relationship with them.

Ask yourself this….as a Quality professional, are the majority of your interactions with co-workers because you’re either rejecting their output or reporting negative results regarding performance metrics?  If this is the case, then you’re reinforcing their negative perception of Quality.  After all, in their mind you only deliver negative information.

Here are two ways to change the perception of Quality, so you’re viewed as helpful and necessary:

1. Put together a short presentation (10-15 minutes) that explains within the context of your job, how you can help them. For example, let people know that you’re willing to review their CAPA if they have any questions, before it’s submitted to QA for approval….assuming this is part of your job.  Don’t worry…chances are you won’t get bombarded with a lot of requests for your time.  Most people just want to know that someone’s willing to provide guidance…it gives them a warm, fuzzy feeling.  Then ask management if you can give your presentation at their next staff meeting….initially target the departments that you work with regularly.  Now your co-workers will know that you do something more than just reject their output!
2. Get to know the people that you work with on a personal level.  Now that doesn’t mean you have to hang out with them on your free time.  Just a simple “hello” or “how’s your family”.  It only takes a few minutes to connect with people personally….think of this as business networking, much like Facebook, LinkedIn, etc.  This will help build positive relationships and since you represent the Quality department, it will influence your co-workers perception of Quality.

How’s Quality perceived at your company?

Do you jam pack your cubicle with so many personal items that it no longer resembles a place for work (overgrown plants, family pictures, personal nicknacks, awards, etc.)….in your defense, it probably makes you feel more like home.  But this clutter can add time to your day and make you less productive because of the time you spend looking for items that are somewhere on your desk….I think ‘somewhere’ has a zip code, along with several of my missing documents.

By following a simple Japanese philosophy known as 5S, you’ll become better organized and as a result will increase your productivity….one of the many benefits of a Lean office (or cubicle).  The philosophy is based on five Japanese words that begin with the letter ‘s’ and have been translated to english words that retain their original intent.

5S PHILOSOPHY

1. Sort (Seri) – Go through everything in the workplace (i.e. your cubicle) and only keep what’s necessary and relevant to work….store or discard items that aren’t needed.
2. Straighten (Seiton) – Assign a location for each item kept….you can create a ‘crime scene’ outline with tape indicating where each item goes, along with a label.  Before you start taping, make sure the placement promotes an efficient workflow….keep items that you use frequently close by so you don’t waste time retrieving them.
3. Shine (Seiso) – Keep your work area clean….that means at the end of each day, straighten up your cubicle so items are returned to their assigned location and you can begin the next workday organized.
4. Standardize (Seiketsu) – Make sure everyone follows the same, standardized practices….anyone borrowing your stapler, for example, needs to be told where to place it when it’s returned.
5. Sustain (Shitsuke) –  Like any program, there needs to be a control in place to make sure you don’t slowly fall into your old habits of piling things in your cubicle….periodic audits work best.  Assuming your company practices 5S, work with your EH&S department to integrate 5S in their office safety checks….cluttered cubicles can represent a potential tripping and fire hazards.

Watch how Kyocera’s North American Headquarters in San Diego implemented 5S in an office setting….yes, it included their cubicles!

Now that your Quality System is in place, does your staff have the mindset to support and improve the system?  Creating and nurturing a quality mindset isn’t limited to just quality type activities, such as internal audits.  It’s everything that you do in addition to audits….that includes your actions and attitudes towards quality.

I thought I’d have some fun and use David Letterman’s top 10 format to show you how your actions can shape the way your staff perceives quality.

TOP TEN ACTIONS THAT SCREAM “YOU DON’T CARE ABOUT QUALITY”

No. 10 – Your staff isn’t allowed to make improvements to the Quality System or procedures.
How it’s interpreted: You personally implemented the Quality System and wrote the procedures, so improvements are like saying ‘your baby is ugly’.

No. 9 – You don’t like the results of an internal audit, so you negotiate with the auditors what you want them to report.
How it’s interpreted: You have no interest in fixing the issues and you don’t want to be on your bosses #$%^ list.

No. 8 – You set metric targets well below historical performance.
How it’s interpreted: You want to guarantee that you meet your targets every month and aren’t interested in making improvements.

No. 7 – You select performance metrics that only showcase what areas of your department or business are doing well.
How it’s interpreted: It’s all about making you look good during the management review and you aren’t interested in knowing how well your Quality System is performing.

No. 6 – You ‘shoot’ the messenger in Quality Management Reviews when you don’t like the data.
How it’s interpreted: You don’t like hearing about issues, so next time the presenter should report only positive information (plus anything that makes you look good) and ignore the issues.

No. 5 – You get Certificates of Analysis (C of A’s) with your incoming raw materials and you never look at them.
How it’s interpreted: You’ll take anything from your supplier, because you don’t want to be bothered making sure you’re receiving quality materials that meet your requirements.

No. 4 – You have a lot of nonconformance’s for the same issue.
How it’s interpreted: You’re investigation doesn’t have to be thorough and you don’t care if the root cause is ever found….just close the record on-time!

No. 3 – Your training has lapsed and yet you’re still able to perform activities that require your training be up-t0-date.
How it’s interpreted: Training’s not that important.  It’s o.k. to continue performing your job, even if it means you’re out of compliance and you’re following an expired/different version of a procedure.

No. 2 – You don’t spend time throughout the year auditing your Quality System, then a few weeks before an external audit you plow through all of the elements.
How it’s interpreted: Internal audits aren’t important….you just need to make it look like we have an internal audit program.

DRUM ROLL PLEASE….

No. 1 – Before signing a controlled document you ask “what date do you want me to put on this?”
How it’s interpreted: It’s o.k. to back date (aka lie).  Everything documented in your Quality System doesn’t reflect what’s really going on.

Hopefully these examples help illustrate how your actions and behavior can influence your staff’s mindset regarding Quality.

What’s your top 10?  Share them in the comments section.

If you use brainstorming as a tool and would like to communicate the results creatively, then you should learn how to Mind Map.  The concept was created by Tony Buzan as a way to communicate information visually through pictures and word associations so you remember the information more easily….a majority of us think visually, plus it’s a fun way to jazz up a list.  But don’t think this tool is limited to just brainstorming….you can also use it to solve business problems, find root cause, etc.

First you start out with a central idea, and draw main branches that represent words related to it, followed by smaller branches….don’t forget to add pictures!  Although you can purchase mind mapping software, I think hand drawn maps have more ‘personality’.  Check out the map by Paul Foreman, an experienced mapper and talented artist….most of his maps focus on inspiration.

Since hand-drawn maps aren’t a practical solution in the business world, I’ve been spending time evaluating mind mapping software that’s easy-to-use….stay tuned for my final evaluation.

If you have an electronic data management system for your electronic records, then from time-to-time you’ll have to deal with the unpleasant task of revoking access to users….keep in mind that your electronic system is a closed system, meaning that access is controlled at all times.  Use these three questions to help you determine when revocation is appropriate and how to manage the process:

1.  Under what situations should a user have their access revoked? From a compliance perspective, access should be revoked when required training has lapsed.

Anytime there’s a training revision that impacts an electronic system, you should alert users in advance that training must be completed before the effective date, otherwise access will be revoked….think of this advance notice as common courtesy.

From a business perspective, especially when user licenses are limited, you should periodically run a report to determine how frequently (if at all) each user accesses the system.  If it’s been more than one year since activity has been detected, then you should consider approaching management about revoking access to free up licenses.  Many times you’ll find out that a user has changed functional roles and no longer needs access.

2.  Should there be a grace period after training has lapsed? A grace period means that after training has lapsed, you allow users access to the system for a period of time afterward.  From a compliance perspective, you’ve allowed users to deviate from the training requirements and can no longer demonstrate control of the system to an auditor….therefore, you should not allow a grace period.  Plus, it also sends a negative message to users that training isn’t that important.

3.  Once revoked, how soon should access be restored? It really depends on your  business policy….if you have one.  Typically, users will quickly complete their training requirements within 24 hours of revocation and expect you to immediately restore access.  This isn’t the best use of your time, since you’ll spend hours revoking and restoring access just because a user didn’t complete their training requirements on-time.

It’s best to have a business policy that identifies the minimum amount of time users must wait after revocation has taken place….the next time you send out a courtesy reminder, users will take notice!

Read more in Issue #14 of the Current Quality Newsletter….Controlling Access to Your Electronic Data Management Systems.

A great big thanks to everyone that submitted questions for the upcoming RCA  interview!!

The interview will be with Denise Robitaille, a published author and industry expert on all things related to Quality Systems (both regulated and non-regulated  industries). She also writes regularly for Quality Digest (just last week she wrote an interesting article on the ‘4 Things You Should Get From Root Cause Analysis‘) and has published several books, one specifically on ‘Root Cause Analysis:  Basic Tools and Techniques‘.  You can read Denise’s bio below….

The interview will take place on Monday, November 23rd.  Once the interview is available, all Current Quality members will be notified and have access to the interview.  If you’re not a member, you can sign up here.

Take care,
Sandra

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Denise Robitaille is the author of nine books. She is an internationally recognized speaker who brings years of experience to the quality profession. She is a Fellow of the American Society for Quality. In 2005, she was recognized in Quality Digest as one of the “Drivers of Quality.”

She is a member of US TAG to ISO/TC176, where she participates at the international level with other colleagues in the revisions to the ISO 9000 family of standards. She is also an RAB-QSA certified lead assessor and an ASQ Certified Quality Auditor.

Denise has helped numerous organizations to achieve ISO 9001 registration and to improve their quality management systems. She has conducted training courses for thousands of individuals on such topics as document control, corrective action, root cause analysis, management review, auditing and implementing ISO 9001. Denise’s books include: The Corrective Action Handbook, The Management Review Handbook, Document Control: A Simple Guide to Managing Documentation, The Preventive Action Handbook, Managing Supplier Related Processes and The Insiders’ Guide to ISO 9001:2008 (co-author). She is a regular columnist for Quality Digest and The Auditor and is the author of numerous articles.

Based on the results of the vote, it looks like the next interview will focus on Root Cause Analysis (RCA)….see results below.  So now it’s time to start submitting potential questions that you’d like me to ask the author….don’t hold back!  Please submit your questions to me by Friday 13th (I thought I’d pick a date that was memorable).

For those of you that voted for a topic other than RCA, I’ll use the information below to schedule future interviews.

Thanks for your participation….Sandra

SUBMIT YOUR QUESTIONS HERE

Join Current Quality today so that you can benefit from the upcoming interview.

I’m in the process of making arrangements to interview an author that’s very knowledgeable on several key Quality topics. Since the interview won’t take place for approximately one month, I wanted to give you the opportunity to vote on the topic that interests you most….the topic with the most votes will be the focus of the interview.  I’ll then post the results and will give you the chance to submit potential questions that you would like me to ask the author….sounds great, right?

Not a Current Quality Member? Sign-up today so you can participate in the upcoming interview….only members have access to the interviews.

Please make sure to select ‘next’, then ‘submit’, otherwise your vote will not get captured….thanks.

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