Editor's Note: This is the 13th installment in the monthly series on The F.P. Horak Co., a Bay City, MI-based printing firm pursuing ISO 9002 registration.
ISO expects certain things from compliant companies. One hundred and thirty certain things, to be exact. That's the number you get when you add up all of the elements and subclauses that an ISO-registered organization must follow.
Some people refer to the 138 things as directives. Kevin Krzyminski, quality assurance manager at The F.P. Horak Co., prefers to call them "shalls"—as in "You shall do this" and "You shall do that."
Auditors make sure that companies questing for ISO certification stick to the shalls. They do this by checking over the quality system, combing through documentation and talking to employees.
The number of auditors needed to conduct this type of examination depends upon the size of the company under scrutiny. At Horak, one auditor sufficed.
Recently, the printing company underwent a pre-assessment: a mock audit meant to gauge the overall strength of a company's quality system. Over the course of two days, a single auditor assessed each element and subclause at Horak. He also spoke with 32 Horak employees.
Although the auditor will always meet with some of the same people during a visit—such as the managers responsible for the quality system—he will generally talk to people at random, depending upon their involvement with the quality system. For example, when assessing element 4.5 (purchasing), the auditor will pick a person in the purchasing department.
"The actual elements would direct you to talk to certain people," Krzyminski says.
Since the word "audit" carries negative connotations, one might assume that ISO auditors hope to find fault with the companies they assess. Nothing could be further from the truth, according to Krzyminski. Horak's auditor worked with the company, not against it. That's why Horak requested the same person for the actual audit—scheduled to take place this quarter.
"The relationship between us and the registrar has been very cordial," Krzyminski stresses.
Once finishing the pre-assessment, the auditor sent Horak a report that itemized his concerns—14 in all. Not bad, considering there are 138 directives.
Still, the champagne corks aren't popping yet. A company that does well during a pre-assessment can still fail the final audit. As the auditor clearly states in his report, "Simply reacting to the concerns identified does not guarantee successful passing of ISO 9002."
Krzyminski believes that the auditor's wording is meant to keep the company cautious. Get too cocky after a pre-assessment and you're bound to become lax. Then your quality system suffers. Better to stay alert and address the auditor's concerns at the same time. That's Horak's plan.
The auditor's 14 concerns were easily fixed. For example, the auditor found a procedure that stated a document should have been updated weekly. In actuality, Horak updated the document quarterly. The company resolved the issue by changing the procedure to read "quarterly."
The auditor also felt that the quality system didn't clearly define managers' responsibilities. He wanted to see something that showed who reported to whom. Krzyminski addressed this issue by writing up a more detailed description for each manager. He then attached the new documentation to the quality policy.
"I gave their names and a description of their range of control," Krzyminski says.
Horak came up with similar simple solutions to address all the of auditor's concerns. In fact, Krzyminski classifies the 14 concerns as minor non-conformances—not the type of problems that usually cost a company ISO certification. The auditor didn't report any major non-conformances. That's nice to know as the actual audit draws closer.
"None of the concerns could have been classified as a major," Krzyminski says. "That's a comforting thought."
—Jerry Janda
Next Month: Getting ready for the audit.
- People:
- Horak
- Kevin Krzyminski
- Places:
- Bay City