Editor's Note: This is the 12th installment in the monthly series on The F.P. Horak Co., a Bay City, MI-based printing firm pursuing ISO 9002 registration.
Two pieces of free advice.
First, always schedule a pre-assessment before attempting an actual ISO audit.
Second, never schedule a pre-assessment immediately after an internal audit.
These words of wisdom come courtesy of Kevin Krzyminski, The F.P. Horak Co.'s quality assurance manager. He speaks from experience. Horak's pre-assessment, a mock audit conducted by a registrar representative, took place a mere two days after management review—the meeting where Horak's Quality Council went over the outcome of the internal audit.
To give the internal auditors adequate time to perform their normal duties, Horak extended the internal audit by a week. Problem was, management review normally takes place right after the internal audit.
Originally, management review was to happen the week before the pre-assessment. Stretching out the internal audit forced the Quality Council to postpone the meeting to the week of the pre-assessment.
ISO decrees that every company must have "an assigned executive with responsibility to the management system," and at Horak, that executive is President and COO Tim Dust. He met with the Quality Council during management review to discuss the findings of the internal audit.
Time to Talk
Major non-conformances, the severe problems discovered during the internal audit, topped the list of topics covered during management review. According to ISO, those participating in management review must come up with solutions for major non-conformances.
In addition to major non-conformances, the council also discussed minors. One minor non-conformance was that employees couldn't summarize Horak's quality policy. The Quality Council suggested displaying small posters, explaining the policy, prominently.
Dust had a few ideas of his own. "Tim is going to reissue the quality policy to the management team and explain that they are responsible to disseminate it to the rest of the workforce," Krzyminski says.
After the council reviewed the internal audit, it turned its attention to reports on the quality system. The council looked over internal spoilages and the complaint analysis.
Internal spoilage, or waste reporting, measured labor losses and material costs associated with rework. By pinpointing factors that led to waste, the council could propose ways to reduce spoilage.
A Look From the Outside
While waste reporting measured the company internally, the complaint analysis provided external measurements of the quality system. When a customer complained, Krzyminski entered the grievance into a database. He then output a pareto analysis—a grouping that took the 10 biggest problems and listed them by cause and department. After dissecting the analysis, the council could suggest ways to avoid the same complaints again.
Once the Quality Council adjourned, Horak only had a few days to prepare for the pre-assessment. It was hectic. Employees even began to question the necessity of the pre-assessment.
Krzyminski could think of plenty of reasons. The pre-assessment would check the thoroughness of Horak's internal audit. It would also give employees an opportunity to take part in something similar to an actual audit.
Two days didn't provide enough time to implement the council's suggestions and fix all of the problems the internal audit unveiled. Still, Horak did make improvements.
After the internal audit, Krzyminski reported that employees lacked a clear understanding of documentation. When the auditor conducted the pre-assessment, however, he found a knowledgeable staff. After the internal audit and management review, employees brushed up on documentation.
"It was amazing how much awareness was created in two days," Krzyminski says.
Room for Improvement
Horak didn't score high marks in all areas, however. The auditor pointed out some minor non-conformances, such as maintenance (element 4.9)—that is, the preventive maintenance of equipment.
While Horak kept records of maintenance and acknowledged maintenance in the quality manual, the auditor expected written procedures that stated who is responsible for maintenance, how often it happens, and what it entails. Horak didn't have these procedures. So Krzyminski will prepare them in time for the actual audit.
Not all of the auditor's remarks were surprising. He noted flaws in element 4.7, control of customer-supplied product, confirming the internal audit's findings.
Horak's written procedure for element 4.7 states that customer-supplied product, such as film, must go through the receiving department, where it is inspected and verified. But this didn't always happen.
"Film doesn't come in through shipping and receiving," Krzyminski explains. "It comes in through next-day air and goes to CSRs."
People still inspected the film, but not the people specified in the procedure. That's a non-conformance. So Krzyminski will rewrite the procedure to reflect what really happens to customer-supplied product.
Krzyminski will also have to correct the problems mentioned in the auditor's official report—once he receives it. He doesn't expect a bad report. In fact, if the pre-assessment had been an actual audit, Horak might have received ISO 9002 registration.
"It went pretty well," Krzyminski offers."
—Jerry Janda
Next Month: The auditor's report.
- People:
- Horak
- Kevin Krzyminski
- Places:
- Bay City