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72 PCB007 MAGAZINE I DECEMBER 2020 tralized control also assures all documentation follows the standard format(s) that have been established and provides a control mechanism for any proposed documentation revisions. Master File Whether electronic or paper-based, there needs to be a master list of all documents un- der control along with the document name, re- vision, and date. A master set of current revi- sion original documents needs to be kept in a secure, restricted location (both paper and electronic). Controlled Document Whether paper or electronic, there needs to be a method for identifying and supplying the current revision document to the workforce that needs them. For paper systems, a colored stamp (red works well) and the words "con- trolled document" should be used to physical- ly stamp the title page of all procedures when issued. The controlled documents should be posted in the area where the work is being done, and a record needs to be made noting the physical location of each controlled doc- ument that has been issued. This traceability will be needed to effectively recall all issued controlled documents when revisions change. For electronic systems, control is typically eas- ier to manage through user read-only access to job-specific controlled documents as long as employee terminals are available wherev- er the documents are needed. High-level doc- uments, such as the quality manual and ISO specifications, need to be included in the docu- ment control system, serialized, and have lim- ited distribution. Uncontrolled Document An uncontrolled copy of procedures and work instructions often needs to be printed for training or reference purposes. These will not be recalled when there is a new revision. In a paper system, these are unofficial copies that are photocopied from the masters and still need to be issued from document control and stamped "uncontrolled document" in green ink (or any contrasting color to the controlled choice) because they are primarily created for distribution outside the control of the facility. Example verbiage that can be used to address this in the document control procedure may in- clude: "Any customer or employee desiring a pro- cedure to take home for review will be issued an uncontrolled copy. Uncontrolled copies are for reference only, and shall not dictate procedure." In an electronic system, a very good way to han- dle this is to add a timestamp to the document footer. A date and time will print on the docu- ment with an expiration date (e.g., 24 hours), af- ter which the document becomes obsolete. No Handwritten Notes/Changes This is another area where many companies get busted, with forms and logs being the usu- al suspects. The system should be set up to not allow any form of manual handwritten chang- es. Some companies allow this practice as long as the change is signed off and dated, but that opens up a whole other can of worms (who is authorized to make changes, how is this tracked, how do these changes become perma- nent, etc.), and presents an open invitation to be abused. The "no handwritten notes/chang- es" clause needs to be specifically written into the document control procedure and requires discipline to become part of the culture.

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