Doc Control
This is how we handle it:
Quality Management System documentation is reviewed and approved for adequacy prior to issue.
The Quality Manager is responsible for the control of QMS documentation.
The Master Index of Controlled Documents & Approval Sheet contains the latest revisions.
The Operational Notebook is readily available to employees to ensure their awareness of the relevant procedures and have access to quality management system documentation.
Production documentation for product being built is listed on the Product Matrix for a specific part number. It is kept in a 3-ring binder located in the stock room. The Product Matrix contains the latest revisions of production documentation.
Customer supplied production documentation may be included on the Product Matrix and in the 3 ring binder. When revised or new customer supplied production documents are issued, the product matrix is updated with the change, new revision, initial and date.
Instructions for generating Production documentation is found in SOP 1 Manufacturing Documentation.
Documents are re-approved as necessary to update approved changes and are incorporated into the documentation. Red lining of production documents is acceptable and are identified with an initial and date. They are forwarded to the Quality department for review and approval. Red lined documents must be replaced within 60 days.
Obsolete documents are identified to prevent their unintended use. This is accomplished with either a red stamp or hand written with red ink, “OBSOLETE" or "Reference Only".
The Production Manager is responsible for the data collection and document/router issuances into production and ensures the latest revision of manufacturing and test instructions is indicated.
Employees verify they are using the correct and latest revision of production documentation for the work being done. Manufacturing and Test Instructions are indicated on the traveler. The latest revision is then found on the Product Matrix located in the 3 ring binder for the specific part number being built.
I do keep the original initiated documents on the computer. They are accessable to all employees and I hold training sessions to inform everyone how to get the latest rev.
Works good so far.
Paula
