Defects shouldn't be a way of life
In industrial manufacturing, quality issues may appear for any number of reasons. Changes to materials, environment, processes, personnel, scheduling, or other factors may take place by design, be forced due to circumstances or happen completely by accident, resulting in nonconformity.
While well-planned operations have steps in place to determine these issues early by reviewing finished parts or components at predetermined phases, it's ideal to avoid nonconformity or defects as often as possible by preventing them from happening in the first place.
One of the best ways to mitigate quality issues, is to anticipate and deal with them early. This is most effectively done during part design and development, prior to launching a new product or component.
Just as repeatable audit/review processes exist throughout manufacturing, best practices implemented early, during conception and design, will help smooth out and hopefully eliminate the unexpected.
Quality Liaison Services recommends a systematic approach to part design and development which includes 3 key validation steps to generate more consistent quality outcomes:
- Engineering validation
- Quality validation
- Volume validation
The engineering validation creates as much opportunity as possible for perfection while the part is being conceptualized. Here drawings are formally discussed and reviewed, perhaps for the first time. Traditional factors considered in the design phase address how the parts will be run or produced on the shop floor, materials options, key machinery, potential investment required.
A thorough engineering validation, listed here as an initial step in the quality process, also addresses broad aspects of a particular project outside the scope of quality. What is the importance of the part in the company's portfolio? Can / should the part be made using existing operations / equipment / personnel / shifts / facilities? Is the part a significant revenue opportunity? Perhaps it's only a necessary expense to accomplish a particular design objective or meet the needs of an important customer. Strategy necessarily affects engineering priorities.
Manufacturers determine critical factors during a well-organized engineering evaluation process. QLS can assist in developing repeatable engineering evaluation criteria. Our representatives bring industry-specific experiences to enhance our customers' internal competencies, delivering profitable outcomes.
The quality validation is the practical outworking of the engineering concepts. In the quality validation phase, the ability to create the part or product efficiently and according to design and within the existing facility is tested. In this step, engineering validation assumptions yet to be proven are carried out successfully, ruled out or tweaked. The QV is the opportunity to confirm the EV, and in many cases helps improve the EV for future projects.
QLS representatives recommend a Six Sigma approach to quality validation. Manufacturers who develop repeatable methodologies to test and measure quality, avoid the business disruptions of nonconformity. Daily execution of such methodologies leads to greater efficiency and profitability, improves communication, encourages innovation. QLS helps our customers manage and enhance their quality assessment capabilities or implement best practices for the very first time.
Once the concept is settled and production processes confirmed, parts should be tested in volume runs. It's ideal (and most cost effective) to set this up in a test environment, especially if major operational change is anticipated. The volume validation is the final opportunity to nail down the production process and identify challenges prior to making any investment.
For a product designed around a typical short run, 60 parts is a minimum industry standard for successful volume validation. This is the opportunity to systematically monitor and report on questions or unknowns remaining from the EV and QV. The VV is the time to establish and maintain issue-free production, by collecting / analyzing data at key phases and documenting the newly created defect-free process.
Ongoing quality validation should a habit
Avoiding manufacturing defects up front saves a wealth of aggravation, effort and cost. It's a necessary first step for optimal production. But ongoing monitoring, evaluation and communication should also be built into each project. "Set it and forget it" works best when review is performed periodically and consistently.
Well managed EVs and QVs are the foundation for where to focus in keeping documentation up to date and communicating well with stakeholders from the end customer to the shop floor. When companies maintain these good habits, they improve multiple factors within the operation and ultimately, the bottom line.
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