I am watching Barb Boyce “torture” her employees. It’s a word she uses often, but whenever she says it, her employees smile. It’s not torture, of course; instead it means they will be quizzed on their manufacturing processes by the President of the company herself. Barb does it in a light-hearted manner, with lots of humor and praise, but she digs… deep. She is making sure her people know every inch of their process, and that any possible deviation between operators is standardized. I hear the words “harmonized production processes” a lot.
In 2006, Pulse Medical Inc. contracted Oxebridge Quality Resources for implementation of an ISO 9001:2000 quality management system. Manufacturing shielded aprons and leaded eyewear for x-ray protection, Pulse also pushed forward on CE marking under the European Commission’s PPE (personal protective equipment) directive, in order to sell their products in Europe.

Completed aprons and thyroid shields awaiting final QC inspection.
Fast forward to 2011, and the company had moved from its original facility in Fort Lauderdale FL to a larger building in the rolling mountains of Blue Ridge GA. The transition was not easy. Only half of Pulse’s original workforce opted to relocate, and while this meant some much-needed jobs for the Blue Ridge community, it meant spooling up a training program for a new set of textile sewers, lab technicians and managers. The physical move took its toll, too, shutting down the company for weeks as both original and new equipment were installed. A larger warehouse meant more shelving to put up, more lighting to wire, and shipping of the entire inventory northward. Problems arose with a new VoIP telephone system, equipment needed recalibration due to jostling during shipping, and relocated South Florida workers struggled to settle into a very different, albeit beautiful, region of the country. Owners Gordy and Barb Boyce were worried the “perfect storm” of new problems would result in a decrease in the quality of the company’s products, something they were extremely proud of.
And looming on the near horizon: a special ISO 9001 audit by registrar SGS, to assess the new facility in order to maintain certification. There are no allowances for relocation under ISO 9001: a nonconformity issued by a certification body auditor is the same whether the company stays put, or if it moves. ISO 9001 is unforgiving in such situations.
Making things more challenging: Pulse’s previous auditor had retired, and a new auditor would be assigned. The company had no idea what this new auditor might bring to the table. Other companies may have been content to “take the hit” and let their ISO 9001 certification lapse, even temporarily, given the circumstances.
Crunch Time
The Boyces were not having it: Gordy is a former Navy SEAL and Barb is a former registered nurse; they are accustomed to tackling problems head on. They were going to keep their certification alive, and actively use the quality management system to — wait for it — manage the company’s quality system. This would be a real life test of ISO 9001’s ability to not only improve, but to quickly regain footing after a difficult setback.The first thing company President Barb Boyce did was to dramatically ramp up training, by using the relocated workers to train the new hires, while adding a journal style record keeping method to capture training strengths and weaknesses in real time. VP of Operations Marbelis Morejon began conducting 10-minute all-staff “Special Training” sessions to tackle issues within 24 hours from the time they arose, as well as to train new hires on company policies and procedures. Even before the furniture and equipment were fully in place, Barb printed copies of manufacturing process maps and taped them to the tables, so every operator would see them, every day, to learn their processes.
When SGS arrived, the audit went smoothly and Pulse maintained their certification. Crisis averted.
Not Stopping There
But it wasn’t enough. The company was struggling with maintaining consistent quality due to the “green” workforce, and changes in processes necessitated by new equipment and a different factory layout. The process maps were updated to reflect most recent practices, and new tools were implemented to help ensure harmonized production. More template patterns were developed to aid in consistent material cutting; preventive maintenance procedures, which were informal previously, were documented and hard-coded into the system. A complete set of “golden sample” aprons was created to assist fabricators in knowing exactly what each model had to contain.
Management reviews were increased from an annual frequency to quarterly, and nonconformity data was collected at a higher level of detail, allowing greater clarity in trend reporting. Now Gordy and Barb didn’t just know what quality-related problems they were facing in the abstract, they knew exactly what the defects were, and where in the company they were being generated.
Using the improved data, the CAR (corrective action request) system — rarely used in the past — became the primary tool for driving improvement. All employees received training on filing CARs whenever a problem was suspected or noticed. Management began filing CARs when nonconformity trends were spotted. The CAR database itself provided additional data on the improvements being made, along with tracking of any problem which recurred despite best efforts, so they could be permanently resolved. CARs submitted by employees as process improvement suggestions jumped from 35% to 66% in six months. Customer complaints, formerly logged separately, were now logged in the CAR database as well, allowing improved trending and problem resolution. Reps and dealers received special training on promptly reporting any customer dissatisfaction for fast resolution.
Keeping it Up
Things were turning around. The disruption brought about by the move and sudden hiring of a new workforce was brought to closure in record time, and things returned to a new, improved normal. Return rates dropped, customer complaints dropped, order entry errors plummeted and on time delivery improved.
Now it’s 2013, and I sit and watch as Barb “tortures” her employees. She opens their process map, and walks through every step, not only testing each operator on their knowledge of the process, but also personally vetting the accuracy of the document itself. Variances between practice and process map are noted for correction, and she makes a list of any activity that is not documented which could lead to inconsistency between operators.
Throughout it all, jokes are tossed out, making the whole thing serious in purpose, but decidedly light-hearted in execution. The employees certainly don’t feel “tortured,” and they come out of it reassured that they truly know what they are doing, and can answer an audit question from any auditor SGS — or anyone else — may throw at them. This is a workforce that won’t need to “practice” before every audit.
This is the level of management engagement every ISO 9001 consultant expects to see, but rarely does. So often procedures are written and remain hidden on a computer somewhere as operators slowly deviate from the practices defined in them. Then, during audits, discrepancies crop up, and the senior management argues that such a thing can’t be possible.
Worse yet, companies fail to use the ISO 9001 system — including the aspects related to process management, corrective action and self-assessment — to drive improvement. Fewer still think to use it to manage crisis. And yet Pulse Medical is proof positive that it not only works, it works well.
For more on Pulse Medical, visit www.pulsemedical.net.
Christopher Paris is the founder and VP Operations of Oxebridge. He has over 35 years’ experience implementing ISO 9001 and AS9100 systems, and helps establish certification and accreditation bodies with the ISO 17000 series. He is a vocal advocate for the development and use of standards from the point of view of actual users. He is the writer and artist of THE AUDITOR comic strip, and is currently writing the DR. CUBA pulp novel series. Visit www.drcuba.world