Current Quality Blog

Redefine Your Quality Management Strategy

Sandra Gauvin — Wed, 25 Aug 2010 01:00:12 +0000

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.

Do Performance Reviews Really Measure Performance?

Sandra Gauvin — Thu, 19 Aug 2010 14:30:05 +0000

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.

Does Personality Type Matter When Selecting a Project Team?

Sandra Gauvin — Fri, 06 Aug 2010 20:39:44 +0000

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).

Should You Ever Reopen a Closed Non Conformance Report?

Sandra Gauvin — Fri, 06 Aug 2010 14:04:08 +0000

Photo: Help Key by Petr Kratochvil

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.

Is Your Brainstorming Session Doomed?

Sandra Gauvin — Thu, 01 Jul 2010 13:43:06 +0000

Photo: Bright Idea by Zaldy Icaonapo

Have you ever wondered why a brainstorming session that you participated in or facilitated, never really got any traction?

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

Do Your Procedures Read Like A Text Message?

Sandra Gauvin — Wed, 23 Jun 2010 17:17:25 +0000

Photo: Woman reading sms
by Petr Kratochvil

Communicating With Acronyms

I remember the first time I received a text message. I spent several minutes trying to decipher it, before calling the person to ask what they were trying to communicate. Your Standard Operating Procedures (SOPs) can be equally as challenging (and frustrating) to understand if they include a lot of acronyms.

In some industries, like biotech, it’s common to use a lot of acronyms and buzz words in your conversations, emails, and documents….it allows you to communicate a lot of information in less time. If you have worked for the same company for years, then acronyms aren’t a problem. But for new hires, it’s a constant struggle to understand the meaning, even if you’re not new to the industry.

I remember starting with a company that used almost all acronyms as a way to communicate….I had more than 10 years of biotech experience at that time. I found myself struggling to understand conversations, meeting discussions, and SOPs because of the excessive use of acronyms and buzz words specific to that company. It can be challenging to grasp the general meaning when very few english words are spoken or written….it makes me wonder how many times the use of acronyms are the source of confusion, resulting in nonconformances. And let’s not forget that it extends the learning curve for new hires (even experienced new hires), costing an employer time and money.

If possible, it’s always best to limit the use of acronyms. But if you must use them and they’re part of your culture, then follow these three communication rules:

Only use acronyms if you’re repeating a word or phase several times throughout a document.

Before you use an acronym, spell the word out first, followed by the acronym in parenthesis. Once spelled out, you can then use just the acronym throughout the document.

Provide new hires with an acronym glossary during orientation so they can use it as a reference guide…make sure the glossary is always up-to-date.

One Step Closer To Achieving Work Life Balance

Sandra Gauvin — Wed, 09 Jun 2010 12:58:03 +0000

Do you work with someone that constantly puts in long hours every single day? They work through lunch, stay late in the evening (at least until 7 PM), and take work home with them!

I bet your co-workers are upset because they feel this person has raised the bar too high and now management will expect the same long hours from them.

I used to work with that person and soon realized they had super human powers….only kidding, but just about the super human powers!

On occassion you may have to work late….that’s expected. But if you’re constantly working long hours, chances are you’re not managing your time well, which is the source of your stress….or as we Quality professionals say, it’s the root cause. Over time, stress will affect your personal and professional life….and eventually your health.

Here’s a short video (3:42 minutes) that was put together for a project at Astra Zeneca pharmaceuticals….the team shares a lot of practical time and stress management tips. So in the spirit of this video, watch while eating your lunch…Enjoy!

Is Your Understanding Of A Quality System A Little Fuzzy?

Sandra Gauvin — Tue, 25 May 2010 17:10:16 +0000

If you were asked to explain ‘what is a Quality System’, could you do it? The reality is that most people don’t have a clear understanding themselves and would be hard pressed to explain it to others…regardless how long they’ve worked in the Quality field.

In general, a Quality System is a collection of processes, policies, procedures, work instructions, forms, etc. that make up your business. The actual scope of the System, where it begins and ends, is defined in your application to regulators and certifying bodies.

The scope would typically include those processes that have the potential to impact the quality of your product/service either directly or indirectly (e.g. manufacturing, training). Sales and marketing are often excluded because they don’t have an impact, making them off limits during an audit.

But what if your company is ISO certified and is regulated by the FDA….does this mean your company has two Quality Systems?

Every company has just one Quality System that’s regulated or monitored by one or more external sources, each with their own requirements. It’s common for people to confuse the concept of a Quality System and will often state they have ‘twenty something’ Quality Systems, when they really mean processes.

I sometimes flinch when I hear Quality leadership make this common mistake, reminding me of Inspector Clouseau’s boss, Chief Inspector Dreyfus, in the Pink Panther movies.

So, the next time you hear someone say they have more than one Quality System, you’re now armed with enough information to educate them as to why they only have one.

Leave a comment and let me know if leadership at your company makes this common mistake?

Changing The Perception Of Quality

Sandra Gauvin — Thu, 20 May 2010 19:58:40 +0000

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:

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!
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?

Creating a Lean Office With 5S – No More Cubicle Clutter!

Sandra Gauvin — Fri, 14 May 2010 16:51:38 +0000

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

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.

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.

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.

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.

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!