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Overview of 2019 Quality Show – Quality Management in Laboratories and Manufacturing Operations

By Allen Licha, PMP, Cospheric LLC

Quality Management Systems in Manufacturing and LaboratoryLast month Cospheric attended the Quality Show in Rosemont, IL. As a global supplier of precision spherical particles, striving to provide the highest quality microparticles on the market, quality is a huge part of what we do at Cospheric. Performing accurate measurements is vital to our business. Metrology, the science of measurement, is how we ensure that we can confidently compare the results of measurements made worldwide.

The Quality Show offered an opportunity to learn more about how quality fits with other organizations, what are their challenges, and what are the tools/solutions being used in the industry.

Quality Management System

When I think of Quality, I think of many different aspects, including Quality Planning, Quality Assurance, and Quality Control. I also think of a Quality Management System, which is a set of policies, processes and procedures required for planning and execution in the core business area of an organization (i.e., areas that can impact the organization?s ability to meet customer requirements). The Quality Show focuses on Quality in the manufacturing environment, specifically on measurements, or metrology/CMM. If you are looking for the latest technologies/trends in measurement tools, this show is great!

This is only the third time they have put on this show, so I do believe that future shows will have more emphasis on all areas of quality. The show is well run and very affordable (free for attendees if you register early).

Below are the summaries of the four presentations that I found particularly valuable.

Presentations on Quality Management

Quality Show Keynote – Building a Culture of Quality by Deb Andree, Northrop Grumman

The keynote presentation, Building a Culture of Quality, delivered by Deb Andree of Northrop Grumman was very powerful! She talked about how Northrop Grumman, who is Palmdale facility was awarded Quality Plant of the Year, gets employees to put quality first by communicating the importance of quality in all functions, across all programs and at every level withing the organization.

Three key points she touched on were:

  • Quality is a journey

    • Quality is on-going project, striving for continuous improvements over the previous results, as customers specifications and market demands are constantly evolving.
  • Quality is personal

    • Does each employee in the organization know where they fit in a culture of quality? Is every employee giving a personal guarantee on the outputs they are producing? The actions of each person has a huge impact throughout the organization. The mindset at Northrop Grumman when it comes to quality is that employees are their biggest asset. Employees are highly recognized for their commitment to quality and encouraged to speak up if something does not seem right or they are unsure.
  • Quality is a commitment

    • Executive management support is one of the biggest indicators of whether or not a project will be successful. At Northrop Grumman there is commitment to quality from leadership at every level.

Setting Calibration Intervals with Confidence by Eric Gasper, PQ Systems

Quality Measurement MicrospheresPerforming regular calibrations on measuring equipment is vital to ensure trust with the equipment and the product produced as a result of those measurements. Gasper dived into the importance of having properly defined intervals.

Why is this important? If you calibrate too often, then it is a waste of time and money. If you do not calibrate often enough, then you risk using faulty equipment to measure your product. So how do we determine the proper calibration frequency? Gasper recommends performing a stability study to determine if your measurement system is stable (i.e. in control). We are looking to catch when the measurement tool has an issue or becomes unstable prior to the scheduled calibration date. We are also looking at the results to see if it remains stable between calibrations.

The whole point of this study is to build evidence to support lengthening or shortening the calibration frequency. In either case you will save time by reducing rework/rechecks if calibrations are not frequent enough or save time in performing calibrations if they are too often.

Quality Management at Cospheric LLC

Cospheric - the leading global manufacturer and supplier of precision spherical particlesCospheric Team reflected on this presentation and used it to provide validation for the Calibration/Verification Module that we have recently developed as part of our in-house Manufacturing Execution System. In our system we pre-define Verification Intervals for each piece of equipment, which will prevent the operator to record data for the equipment that has passed its verification date.

We also pre-define control limits which will automatically tell us whether the equipment passed verification (and will be released for use) or fails verification, in which case it will be off-line for troubleshooting and/or calibration. Equipment will not be released for use until a successful verification has been performed. This way we ensure that we only recalibrate when equipment is outside the control limits. We also verify the performance of equipment regularly to ensure that a product will not be released with a faulty measurement.

Technical Learning in the Workplace by Aliesha Anderson, ZEISS Industrial Quality Solutions

In this learning session, Anderson covered the impact of Industry 4.0 on Quality and Manufacturing. She talked about how the manufacturing industry has changed dramatically in recent decades due to new and emerging technologies. Many open positions are vacant due to a skill shortage.

Anderson presented data from the Deloitte Millennial survey, which found that 43% of Millennials envision leaving their jobs within two years and only 28% seek to stay beyond 5 years. In a recent national survey 87% of Millennials cited professional development /career growth as being very important to their decision to stay of leave a company.

What does that mean for companies today? It would be in their best interest to view employee training as an investment instead of an expense.

Benefits and Challenges of ISO/IEC 17025 Accreditation for Laboratories in Manufacturing Facilities by Melanie Ross, Training Products Specialist, ANSI National Accreditation Board (ANAB)

ISO/IEC 17025 is a company level accreditation based on a standard published by the International Organization for Standardization (ISO) titled “General requirements for the competence of testing and calibration laboratories.”

So, what is the difference between ISO 9001 and ISO/IEC 17025?

Ross explains that ISO 9001 is focused on the general quality management system where an organization demonstrates the ability to provide consistent products and services that meet requirements. ISO/IEC 17025 focuses on the management system with technical laboratory requirements. You demonstrate competency of the laboratory. Once key difference between the two is that ISO 9001 is a certification, where ISO/IEC 17025 is a quality management accreditation.

Why should you seek this quality management accreditation?

More agencies are requiring this quality management accreditation, including DOD, DOA, FDA, FAA, and state governments. Another thing that Ross mentions is that if you already have an quality management system you are already 80% there to having your ISO/IEC 17025 accreditation. You can find more information on accreditation and training by visiting www.anab.org.