Current Quality Blog » Continuous Quality Improvement

Building A Quality Mindset With Your Staff (or Not)

Sandra Gauvin — Fri, 07 May 2010 19:04:11 +0000

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.

5 Signs That Your Quality System Is Dysfunctional – Take The Quiz!

Sandra Gauvin — Mon, 30 Mar 2009 15:49:23 +0000

Have you ever noticed that when you start a new job, it’s so obvious what processes need improvement? But then overtime you begin to adapt to the culture and you tolerate the inefficient and dysfunctional practices….sometimes just to avoid conflict. Then over time, you don’t even notice the problems as much….

Take the Quiz below to see if your Quality System is dysfunctional. If you answer ‘yes’ to any of the questions, then the good news is, you’ve just been presented with an improvement opportunity.

1. Does your Standard Operating Procedures exceed 5 pages? Whenever you have procedures that ramble on and on, you really have to question the value to the people using them. Take a look at your procedures and identify the critical information that needs to be in them, then strip way all of the excess information. A great way to format your procedures is by using a system known as Information Mapping , which will typically reduce the size of your procedures and make them easier to read.

2. Do you require more than 3 signatures for all document approvals? If every document requires more than 3 signatures, regardless of the risk associated with the document, then you’re adding too many approval gates that will increase the approval cycle time and will bog down your process and frustrate your people. Most documents should only require an Owner signature, Quality signature, and a Manufacturing Signature, with the exception of higher risk documents requiring additional signatures.

3. Do you have people dedicated to just nonconformance investigations and Quality staff dedictated to their approvals? If you’ve answered ‘yes’ to this question, then you have the greatest opportunity for improvement that can impact the bottom line of your company. If you have so many nonconformance’s that it requires a dedicated staff to work on the investigations and approve the reports, then you’re not getting to the real root cause. If you don’t have a formalized trending program, then now is the time to start so that you can quickly identify issues and conclude if you’ve truly gotten to the root cause by reducing the number of nonconformance investigations (assuming you haven’t added any new products to your pipeline).

4. Do you attend so many meetings that you don’t have time to do your job? Take the time to document all of the meetings that you attend, along with their purpose, frequency, time, attendees, etc. and see if there are any redundancies….if yes, then propose to management that certain meetings be consolidated and show evidence that the same information is being covered in other meetings.

Also, really take a look at the purpose of the meetings because they may indicate that there are systemic problems that can be resolved if you get to the root cause. For example, If you’re meeting daily to determine if an observation is truly a nonconformance, then you need to look at how well your procedure is written, if nonconformance’s are clearly defined, and evaluate the overall training a person receives. You may find out that if you put a qualification program in place that it eliminates the need for the daily meetings.

5. Do you track more than 30 metrics each month? You know the saying ‘the more the merrier’?, well when it comes to metrics, more is not necessarily better. Your metrics should measure important aspects of your business that indicate how well you’re performing and when actions need to be taken. I’ve written a 23 page special report ’Boost Your Quality AND Operational Performance By Following These 3 Simple Rules‘ that’s includes valuable information about performance metrics that you really must read….you’ll also receive a monthly subscription to the Current Quality Newsletter.

Just submit your first name and primary email address in the form below and you’ll instantly get the report once you’ve confirmed your subscription to the newsletter.

Times Are Changing For Biotech Industry

Sandra Gauvin — Fri, 27 Mar 2009 17:26:00 +0000

Just yesterday a bipartisan bill was introduced that could allow lower-cost generic drugs available after just 5 years years instead of the usual 14 years. This is just one example of how government and economic pressures are forcing biotech companies to change their business model and mindset regarding efficiencies.

Over the years we’ve all experienced (or at least heard about) the inefficiencies that were built into their model. For those of us working in the biotech industry, we recognized that the ‘old’ mindset seem to emphasis placing band-aids on broken processes that required an army of people to ‘muscle’ their way through….it was never about fixing the problems. Because of this mindset, many of us are left with inefficient processes that frustrates anyone forced to use them, and to make things worse….the army has been downsized!

NOW is the time to incorporate efficiencies into your business, which is why you really need to read my 23 page special report ‘Boost Your Quality AND Operational Performance By Following These 3 Simple Rules‘. It’s packed with valuable information about how you can improve the performance of your business (or department), which is critical!

You’ll also get a bonus section that will help you get the results that you’re look for by making sure you avoid the 11 mistakes that most company make….and the best part is, the special report is free just for subscribing to the Current Quality Newsletter.

The special report is in the Current Quality Library….you can access it here.

Are Your Resources Limited?

Sandra Gauvin — Tue, 03 Feb 2009 17:31:24 +0000

How to do more with less resources….
It seems like every industry is being hit hard right now, with layoffs in the headlines almost daily. Whether you’re experiencing layoffs or just a general tightening of the belt, you need to figure out a way to do more with less resources.

An easy way to do this, is to really look at the processes that you manage and see if there are any unnecessary or redundant steps that you can eliminate from a process….

Create A Process Map - Start out with a high-level process map (4-6 process steps), then work towards a mid-level one that shows you more details….this is where you start seeing opportunities to lean out your process. Just make sure that you capture the actual process and not the perceived process….it’s very common for there to be a disconnect between the actual process and what’s documented in a procedure.
Challenge The Necessity Of Each Process Step – Each step should have a purpose behind it (regulatory requirement, etc.)….don’t be afraid to ask ‘why’ a step is included in the process if it doesn’t make sense or there’s no apparent purpose or justification for it. Be on the lookout for responses such as “we’ve always done it this way”.
Update Documents - If any changes are made to your process, update your documentation to reflect the changes (Standard Operating Procedure, Work Instructions, etc.).

Take care,
Sandra