All Procedures Missing in Action

by Dean
(Moorpark, California)

I started working for a new company as a Quality Assurance Manager. This company was ISO certified but not ISO compliant. They had documentation that covered most of the areas, but was not truly following thier documentation.

I reviewed the previous ISO audit. This helped me understand the current state of affairs. On thier last audit, they had 2 majors and 11 minors. The majors focused on Document Control and Lack of Calibration.

The auditor found that there were procedures on the floor in many places. However, many of the procedures were not completely reviewed or had different revision levels. Document Control did not know the location of contolled documents

For a corrective action to this finding, the company decided to remove all procedures from the floor. Only the procedures in the computer files were considered to be controlled.

The auditor approved this corrective action.

I was hired about 4 months after the audit. I found that since the procedures were removed from the production floor, operators did not have easy access to them. Document Control stated that he trained all department leads on the process of finding them in the computer. However, most operators were not computer literate. They could not find the procedures.

Because of the lack of procedures, product quality was directly affected. There were several things that I put into place to assure that controlled procedures were on the floor for operator use.

1) Created a database system that tracked all documents, approvals and locations.
2) Rolled the documents into controlled binders back to the floor. Each department had one controlled binder.
3) Made document control responsible for the binders.
4) Updated the document control procedure to reflect the changes.

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