ISO Document Review: Do I HAVE to?
Deciding how to control your documents can be difficult. ISO 9001 requires you to maintain accurate and up-to-date procedures, but doesn’t give a lot of guidance on how to get there. Between the requirements and the implementation lie grey areas and confusion. Let’s take a look at the difference between what is required and what …
Excuse Me, Mr. Auditor, Can I Phone a Friend?
There you are, in the middle of an Internal or External Audit, and the Auditor asks you a question that you are truly not sure about. What do you do? Hit the panic button. Ask the audience for a hint. Phone a friend. Well, there isn’t a studio audience, and chances are the Auditor didn’t …
What’s the Difference Series: NCRs vs NCNs vs CARs vs PARs vs SCARs vs CAPA vs CPARs vs CIP
So, you think you’ve got it all figured it out, and then, BAM! Somebody else comes with a new acronym to throw you off your game. Well, don’t give up so soon. Quality is not that hard, or at least not as hard as some people expect it to be. It all boils down to …
If You Want Guaranteed Success, Then You Need Informal Assessments: Audits on Steroids
Have you ever wondered why the last Internal Audit or External Audit uncovered so many issues even though you thought everything was great? Are most of your nonconformities or corrective actions pointed out by external parties? If the answer to any of these questions is yes then what you may need in order to pass …
Are Training Attendance Sheets Appropriate for Measuring Training Effectiveness?
So you’ve heard about measuring training effectiveness but are unsure about how to do this. You have been filling training attendance sheets for as long as you can recall and so far they have served the purpose. So what is this new question all of the sudden a topic of discussion and what exactly is …
Hello Mr. Auditee: Did Mickey Mouse Help in Your Root Cause Analysis?
Ok, so you issued a nonconformity to your auditee or vendor and you are hoping that they will review the problem in such a manner that the current problem will be solved and similar problems will be prevented from happening again. You ask for a formal response and to your surprise, when you see the …
Hey, Mr. Auditor: This Is a Mickey Mouse Nonconformity. Show Me the Value!
Have you ever been audited and felt like the findings the auditor was bringing up were minutia and almost irrelevant in the context of the major challenges and goals setup in your organization? Did you almost feel like they were mickey-mouse or minutia issues compared to the big tidal waves your organization is going through. …
What Suits Your Schedule Best: Conduct Root Cause Analysis 1 Hr. Daily or Fight Fires 8 Hrs. a Day?
There is not a bigger vicious cycle in this world than that of problems which constantly re-occur because there is no time to stop and solve them correctly. Although we all would like for this cycle to stop, Managers can’t afford letting employees waste time with too much researching and employees don’t have the time …
Five New Year Resolutions for Top Management
Most of us set new resolutions at the onset of every new year. Whether it is losing weight, exercising more (always the top resolutions!) or finishing a degree, we all recognize that a new year and the chance of a fresh start is a powerful combination to motivate us to achieve those goals. So why …
What’s the Difference? Series: Gap Analysis vs. Internal Audits vs. Pre-Assessment
If you have ever wondered what the difference was between an audit, an assessment or a gap analysis, then you might not be alone. When trying to figure out whether your company meets the requirement of a standard, such as ISO, API, Safety, etc.; chances are you are trying to decide which one of these …
Are You Sure the Procedures Your Organization is Using Represent Your Organization’s Processes? Using Process Mapping Concepts to Develop Accurate Procedures
To work properly, procedures have to match the company processes, and each organization must have their own set of processes which should be different than that of their neighbor. Even when companies build or perform similar activities, each of them has different culture and details that will make them unique and therefore they will have …
Do You Feel Like Your Company is Acting Like a Chicken Without a Head? Find Out What Good Process Mapping Can Do for You!
What is Process Mapping Process mapping is an essential technique for identifying all the processes that take place in an organization as well as their interrelation so that it is easy to understand the sequence at which these processes take place. A good process map should be a high level map of how your organization …
What’s the Difference? Series: ISO Goals vs. Targets vs. Objectives vs. KPI’s vs. Metrics
A Game of Words As an auditor I always ask employees to tell me whether they are familiar with the company Quality Objectives or not. Obviously I may not ask that as a straight question but rather something like this: How do you know if you are doing a good job? Has your company established …
Are You Sure Your Torque Wrench is Capable of the Force You are Using It For? How to Determine Effectively the Equipment Needed for Your Monitoring and Measurement Activities
In case you are not sure if the equipment you are currently using for your monitoring and measuring activities is the most adequate equipment or if you are wondering why such as expensive tool is used to inspect a certain part, then it may be worth for you to understand tolerances, accuracy and what the …
Continual Improvement… It’s Not So Easy, a Caveman Could Not Do It!
When I started my career nearly 20 years ago, the world was a little different. People were still smoking in the workplace, Dilbert was in everybody’s desk and the quality program of the month was the joke du jour. Many things have changed since then for the goodness of the world and the quality of …
