New ISO 9001:2015 Quality Standard Changes

Chris Anderson Management Coach Bizmanualz, Inc

Chris Anderson, Management Coach, Bizmanualz, Inc.

Tuesday, Oct 20, 2015

What are the new Document Requirements?

You will learn about the requirement for a quality manual — there is none!  How about quality procedures — None!  quality records — Only to the extent necessary… Hard requirements for documentation are replaced with the term “documented information”.

The new standard is focused less on documentation and more on performance, risk, and designing in quality.

Risk is the new focus to designing in quality.

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Risk Analysis and Risk Management Workshop

Saturday, SEP 26, 2015 from 08:00 AM – 12:00 PM Central

Chris Anderson,, Management Coach, Bizmanualz, Inc.

Chris Anderson,, Management Coach, Bizmanualz, Inc.

What does ISO 9001:2015 require for risk analysis and risk management?

Learn what Risk Based Thinking is and how to apply it to your QMS.

While a formal process of risk analysis or risk management is not required in the ISO 9001:2015 standard, the concept of risk is included in eight areas of the current draft of the new standard.

1. Determining risks and opportunities that affect the quality management system.
2. Planning changes to the quality management system.
3. Evaluating processes, as part of the process approach.
4. Establishing appropriate controls of external providers (such as suppliers)
5. Identifying risks that can affect the company’s products, services, and overall customer satisfaction.
6. New product design and development risks.
7. Determining post-delivery support risks (e.g. warranty, maintenance, and other services).
8. Establishing monitoring and measurement of risks.

The inclusion of risk throughout the standard is referred to as “risk based thinking”. The standard does not require specific processes or procedures for risk analysis, like Failure Modes and Effects Analysis (FMEA), but using FMEAs and Control Plans will provide a basis for risk analysis and management. In this fast paced class we will review some of the core tools used to identify, quantify, and control risks including: Process diagram, FMEA, and Control Plan.

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Using Defect Mapping as a Problem Solving Tool

Tuesday, Sept 15, 2015

Defect Mapping is a problem solving tool used to visually identify and track physical locations and types of defects on a product. As a defect occurs during a process on a product, the location of the defect is identified on a map.

The Defect Map provides information on the physical location of the defect on the product and additional pertinent information as well. The more visual you can capture issues, the easier it is to move forward to defining root cause and corrective action.


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Reliability Engineering Explained

John PaschkewitzTuesday, Sept 15, 2015

An introduction to the basics of reliability engineering that clarifies the definition of reliability and shows how it differs from many other quality functions. Key concepts, primary tools, and the impact of reliability are highlighted.

Examples from several products and industries are used to illustrate the role of reliability engineering. The presentation concludes with a description of the ASQ Reliability Division and the services it provides.

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Value Stream Mapping workshop

ASQ Section 1304 St. Louis Proudly presents

Value Stream Mapping Workshop

Saturday, May 30, 2015

A 4-hour hands on workshop conducted by Amy Slovacek, a value stream mapping expert from Lutheran Senior Services. This workshop is designed to help you learn techniques and enhance your skills using the Lean value stream mapping tool.

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12th Annual ASQ Lean-Sigma Conference at SIUC


will be held Thursday, April 30, 2015 on the 2nd floor of the S.I.U.C. campus Student Center, 1225 Lincoln Drive, Carbondale, IL.
Check-in begins at 8:00 a.m., sessions start at 8:30 a.m. Continental breakfast and lunch will be provided.

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St. Louis Supply Chain Mixer

Networking Happy Hour Hosted by

APICS | American Society for Quality | Institute for Supply Management | Transportation Club

April 30, 2015
5:30 PM to 8:30 PM

Kick off springtime with great food and great conversation at the St. Louis Supply Chain Mixer co-hosted by 4 premier professional organizations. Here’s a great opportunity to reach beyond your current professional circle and make new connections. Bring your colleagues, your boss and your significant other for a festive night out in good company.

The program will include 4 “Table Talk” mini-seminars. Participate in all four 20-minute sessions to be entered for your chance to win fabulous prizes!

Hot and cold plates provided. Cash bar available.

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Using Lean, Six Sigma and Human Factors to prevent patients from falling

Laurie WolfTuesday, May 19, 2015

This presentation will discuss how Lean, Six Sigma and Human Factors Engineering were used to prevent falls for oncology patients. Highlights from three case studies conducted as part of research for PhD requirements will be reviewed. Advantages and disadvantages of the three different mythologies will be compared as they were used to prevent patients from falling while in the hospital.

Case Study #1 used Lean techniques such as standard work to improve fall risk assessment and intervention selection.

Case Study #2 used Six Sigma tools to investigate root causes of falls. An intervention called “Patient Partnering” was developed to encourage patients to call for help and participate in preventing their own falls. There were no falls with serious injury for over 12 months.

Case Study #3 was a qualitative study based on Human Factors principles to understand patient’s perception of fall risk. It was found that patients did not think they would fall and felt particularly safe and protected while in hospital.

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Annual Awards and Elections

Tuesday, Dec 2, 2014

awardsAnnual Awards

Have you received an ASQ certification this past year?  Come and be recognized for your quality achievement at the St. Louis Section 1304 Annual Awards night.  Recipients of ASQ Certifications are eligible for a complementary dinner.

Annual Elections

Every year we elect section officers for key leadership committee positions.

  • Section Chair
  • Section Chair-Elect
  • Section Treasurer
  • Section Secretary

The leadership committee plans, coordinates, and leads all section events; assists members with ASQ opportunities; and represents the section at ASQ functions.  Section leadership provides an excellent opportunity to develop management skills, give back to your section, and help others on their quality journey.  Open positions are available for those ready to take the challenge.

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James Canham, VP of Pharmacy Operations, Express Scripts

Tuesday, May 20, 2014

Express Scripts Facility Tour and Presentation

Learn how Express Scripts Holding Co. became the only St. Louis company to crack the top 50 on this year’s Fortune 500 list. The pharmacy benefits manager landed at No. 24 on this year’s list, which ranks the nation’s largest corporations based on revenue.  Express Scripts manages prescription benefits for tens of millions of Americans on behalf of thousands of clients, including health plans and plan sponsors for employers, unions and government organizations throughout the nation.

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