Quality Management Systems Chris P. James Its Elementary

Agenda Elements of a Quality Management System Product Realization Continual Improvement Resource Management Affects on a FUS Standard Questions

Quality Challenge Baldwin Corp. Scott Co. Colby Inc. McArdle Services Wehr LLC. Not Everything Is Always As It Appears

Elements of a Quality Management System “Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.” - William A. Foster

Elements of a Quality Management System Organizational structure and Responsibilities Process Controls and Methods Data Management Resources - including materials as well as human resources Customer Satisfaction Continuous Improvement (corrective/preventative action) Product Quality (validation/verification) Equipment Maintenance and Calibration Sustainability - including efficient use of resources and responsible environmental operations Monitoring by continual assessment (internal or external)

What Can a Quality System Manage Production System Packaging & Labeling System Facilities & Equipment System Laboratory Controls System

Which Path is Acceptable? ACME Quality Manufacturer’s Quality Program

Product Realization “Quality is not an act, it is a habit.” - Aristotle

What should a quality system manage Product Realization is the combination of all processes (step by step) - from initial design to actual delivery of final product/service - that deliver an output meeting defined requirements (specifications).

Continual Improvement “Quality means doing it right when no one is looking.” – Henry Ford

Continual Improvement 1. Containment 2. Root Cause Analysis 3. Corrective Action 4. Preventative Action

Continual Improvement Containment: Immediate actions to reduce the severity of the identified problem (slow production line, provide for temporary fix/repair, etc.)

Continual Improvement Root Cause Analysis: A detailed review of the issue to determine the true cause for the problem. Utilizing various methods such as 5 why’s, Ishikawa (fishbone/cause-effect) chart, etc.

Continual Improvement Corrective Action: Once the true cause of the problem is identified, action take to resolve/reduce the likely of same problem from reoccurring.

Continual Improvement Preventative Action: Analysis of processes/operations to mistake proof them so as to eliminate problems from happening (prevention)  

Resource Management “The quality of an organization can never exceed the quality of the minds that make it up.” - Anonymous

Personnel Competency and Development Personnel competency can be broken down into the following areas: Determine the necessary competence (skills) Provide training and evaluate the effectiveness Ensure that personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. Maintain appropriate records of education, training, skills and experience.

Elements That Can Be Overlooked The working environment should also be managed to help achieve a conforming product, such as: Human factors: safety rules and guidance ergonomics Physical factors: hygiene, cleanliness noise, vibration heat, light, air-flow security

Affects on a FUS Standard “It is easier to do a job right than to explain why you didn't” - Martin Van Buren

Follow-Up Current State Lab 1 Lab 2 Lab 3Lab 4Lab 5 Follow-Up Requirements Happy Zone

Follow Up Desired Future State Lab 1 Lab 2 Lab 3Lab 4Lab 5 Follow-Up Requirements Happy Zone  Requirements

Questions Steve Schmid, ASQ CMQ/OE Quality Assurance Director