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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Why Surprised?
by: Anonymous

To Anonymous: Why are you surprised? I am on my fourth QA Aerospace job in 6 months and have finally found a QM who is sane, a good manager and proactive in every way! Yes, I am still in shock after working with him for a couple of months. At one of the previous jobs, I was fired/removed after two weeks for trying to correct a tracability issue; actually a Massive traceability issue involving 777 brake units for landing gear. According to my previous training, every 777 brake unit they had sold to Boeing was comprimised by being entirely untracable to any of their paperwork! So how did they pass their BAC audits? I suspect they treated their auditor to nights at a strip club!

access of procedures by user at shop floor
by: Anonymous

Good move to have a better access to documents by people at the shop floor.
However there should be regular briefing or notification of any changes to the procedures or else having controlled copy is only by name and not by practice.

Teh person who receives teh controlled copy should also have means to make the chnages known to the user.

No Procedures
by: Anonymous

Wow, they operated without procedures. That must have costed them a lot of money. I'm surprised thier management let this occur.

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