INNOVATIVE QUALITY PRODUCTS AND SYSTEMS

Quality Advice by Robin Dudash

IQPS President and Instructor Robin Dudash (CQM/OE, CSQE, CRE, CQE, CQA, CCT, ANAB-LA, IATF-LA, MBA) is one of the most qualified quality professionals in the world. In Quality Advice by Robin Dudash, Robin shares her QA industry knowledge on a variety of relevant topics. Robin provides training for the quality professional and private consultation for companies through Innovative Quality Products and Services. She is an instructor of the Internal Auditor Training Course, as well as the Certified Software Quality Engineer Exam Prep Course. In addition, Robin offers Root Cause Analysis Training, ISO 9001 Training and ISO Software Consulting to businesses interested in improving their internal management systems. Check out her blog entries and help inform other industry professionals by sharing online!

Internal Auditor Training Insights from the ISO 9001:2015 Update

What a wild ride it’s been updating the IQPS Internal Auditor Training Course to ISO 9001:2015! I wanted to take some time to contemplate the various opinions out there as we all learn about ISO 9001:2015 together. I have been listening to clients and experts, reading a few books and attending training classes to absorb all the information I possibly could—considering my heavy business travel schedule. All of these classes that tell you about interested parties and risk assessments are great until you have to sit down and define a management system on paper.

  • Where do you start?
  • Do you even need a quality manual?
  • What do you do with the procedures?

Well, I’ve just finished my first ISO 9001:2015 manual and have decided on my approach. First, if your current quality policy manual repeats the standard, throw it away! I can’t tell you how many quality manuals I have read that are just a repeat of the standard. Everybody already knows the standard. My quality manuals have always combined some policy but primarily documented procedures.

Since I already audit ISO 27001 for information security, ISO 14001 for environmental systems and OHSAS 18001 (soon to be ISO 45001) for health and safety systems, all of these systems have one theme in common: identifying and putting controls in place to mitigate risk. These risks include losing information, spilling a drum of oil or avoiding an injury. Now ISO 9001:2015 expects us to mitigate business risks such as losing a sole supplier.

When I looked at all three risk standards, I decided that ISO 27001 was the best fit. After all, ISO 27001:2013 was the first standard to be converted to the Annex SL format. When I first read context of the organization in ISO 9001:2015 and attended my second training class the light came on. They were really talking about the scope document in ISO 27001, which is where the quality manual went!

When I read about contractors in ISO 9001:2015, I see relationships on how ISO 14001 requires you to treat contractors, i.e., those working on your behalf. I also see similarities in statements about communications in ISO 14001 for internal and external communication processes. So for those of you who have organizations certified to ISO 14001 standard, I would incorporate some of this language into your scope document.

For those of you just looking for an ISO 9001:2015 update, I have separated this discussion out from my Internal Auditor Training Course into its own course, called ISO 9001: 2015. I think having audited ISO 27001, 14001 and OHSAS 18001 has given me some brilliant insights and I look forward to sharing them with you!

Corrective Action

One of the keys to continual improvement is permanent corrective action. I have seen various levels of corrective action responses, but very few that follow through and permanently resolve the problem. Hence, the organization continues to operate in fire-fighting mode – chasing a problem that returns again and again. There are several reasons why problems reoccur, and
most of them I am sure you know already:

  • Allowing interim actions to temporarily fix the root cause
  • There is more than one root cause
  • No verification that the action was taken
  • No controls in place to prevent the problem from happening again

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Simplifiers vs. Complexifiers

I recently told a client that when I started working for US Steel at age 19, my boss would enlighten me with jewels of wisdom I have found to be true to this day! One of these principles are, “There are two kinds of people in this world: Simplifiers and Complexifiers. We are going to be Simplifiers!”

I regularly come across quite a few quality management systems that have become complexified through our efforts to please ‘the auditor.’ As recently as 10 years ago, it was the norm for everything to be written down. Every document, including decimal equivalents, had to be controlled… and everything, including pallets, had to be on the approved vendor list.

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