The Dilemma of Procedure Reference on Process Maps and Quality Manuals
A reader asked, “I have the need to create a procedure as part of our ISO program and was wondering, should this procedure be listed on the process map either as a core process or as a supporting process? …
Document Control 101: How to comply with ISO and API without being trapped by your own words
Sometimes the interpretation of the ISO 9001 or API Q1 9th Edition/API Q2 requirements seem to force us to do things we won’t be able to do, or sustain for more than a few months— let alone days…
Red Tag, Green Tag: Color-Coded Tags
When it comes to red tags and green tags, which does your company use? A reader shared this material identification issue with us after a recent audit…
Procedure vs. Work Practice
A reader recently asked, “What is the difference between a procedure and a work practice? For example, when a job is completed it is sent to Invoicing…
How to Write an ISO or API Compliant Quality Manual
How To Build A Perfect Quality Manual Quality Manual Series: Part 3 of 3 Ah, so you read my part 1, “The Abominable Quality Manual,” and part 2, “How Did We Get Here,” and now you are ready to learn how to build a perfect Quality Manual. Well, I have good news and bad news …
Risk Assessment 101: Do It Right the First Time and Every Time
With all the current buzz about Risk Assessment brought about by API Spec Q1 9th Edition, API Spec Q2 and the circulating draft of the ISO 9001possible 2015 version, how is one supposed to know when to do risk assessment…
Web QMS – How Clients Use It for More than ISO
Okay, I’m interested. What else can Web QMS do for us? Mireaux’s Web QMS quality management systems software is mostly known for being an essential tool for meeting all requirements of the ISO 9001 standard…
Farmington Nights – API Spec Q2 Certification: Not for the Faint of Heart
On a beautiful January afternoon in Houston, I prepare to go to Farmington, New Mexico, a town of 45,000 that most people have never heard of. It’s 60 degrees and sunny in Houston…
The Abominable Quality Manual
Is a Quality Manual that simply regurgitates the standard useful for continual improvement? Quality Manual Series: Part 1 of 3 Have you ever seen a Quality Manual that did not look exactly like the ISO standard? Not lately, probably …
How to Determine Critical Suppliers (vs. Non-critical Suppliers) Based on API Specification Q1 9th Edition or API Specification Q2
A reader asks, “I am currently working on transition to API Specification Q1 9th Edition and I got stuck at 5.6.1.1 a) Determine Criticality. We are a repair/remanufacturing facility for the oil and gas industry …
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 …
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 …
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: 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 …
