Knowledge management encourages experiential learning within the organization, as well as mentoring and benchmarking. Included are the critical steps to document this knowledge as a safeguard against losing it due to staff turnover.

The explicit focus on knowledge management is a new addition to this latest release of ISO 9001. It pairs with the push for risk-based thinking, which instructs the organization to explicitly determine the factors that could cause processes—and the quality system—to deviate from the planned results, and to put in place preventive controls to minimize or eliminate negative effects from these spills.

Quality Management Components

An effective QMS addresses quality planning, quality assurance, quality control and quality improvement. Don’t look at these individually; instead, view them as an interrelated continuum.

Quality planning occurs at the design stage, when an organization develops an understanding of the customer’s needs, defines the critical product features and creates the processes to achieve these characteristics. Documenting all of the actions needed to reach these objectives helps focus attention on important steps. Insufficient quality planning opens the door for additional quality-improvement activities.

Quality assurance (QA) focuses on the methods and practices in the prevention of defects. QA centers on the processes and systems involved in creating quality defect-free products suitable for their intended purpose. QA emphasizes prevention over inspection of defects. Potential tests include metal forming simulations and hands-on strain analysis on stampings, and fatigue and durability analysis for structures. QA testing is proactive, trying to first determine the situations where defects could occur and then establishing mechanisms to avoid producing those defects.

In contrast, quality control (QC) is a reactive approach to identify product defects once they have occurred, and to then mitigate their effects. Once defects occur, identification of root causes is paramount in order to implement permanent corrective actions. Consulting with subject-matter experts helps to trace back far enough to determine causality. Among the tools that aid in these efforts: the “five-whys” method and developing an Ishikawa fishbone diagram.

Organizations should continually strive for quality improvement. Opportunities arise from determining the root cause of prior failures, as well as from proactively tackling issues that, while not failures, clearly have room for improvement. Even incremental improvements favorably move the needle. There are several continuous process-improvement methodologies in widespread use, including Kaizen, DMAIC (define, measure, analyze, improve and control) and PDCA (plan-do-check-act).

Look for more information on these topics in the coming months! MF

See also: Engineering Quality Solutions, Inc., 4M Partners, LLC

Technologies: Quality Control

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