While documentation is often viewed as a necessary evil, it is a very important aspect of any quality system but needs to be functional. Part 2 details more tips and techniques to simplify and streamline your QMS documentation.
Now called documented information, this is another area that is prone to an auditor’s finding, and in most cases, results from a lack of discipline. The key concept of document control is that any document related to product quality needs to be under document control. Examples include documents such as procedures, forms, logs, checklists, etc.
I would argue that every document in any organization is related to product quality and needs to be controlled. It is a far superior strategy to include every form, log, etc., in the document control system than to defend to a customer or auditor why the uncontrolled form they just found is not related to product quality in some way.
There are a number of key elements that need to be thoroughly understood and considered within any document control system. These elements are briefly discussed here and need to be defined in the document control procedure.
Document control by committee does not work; every effort should be made to design a system in which all documentation flows through a single person/position, such as a quality analyst or QMS coordinator. Flowing down responsibility to functional departments is a disaster waiting to happen and makes the “control” part of document control very difficult to maintain. Centralized control also assures all documentation follows the standard format(s) that have been established and provides a control mechanism for any proposed documentation revisions.
Whether electronic or paper-based, there needs to be a master list of all documents under control along with the document name, revision, and date. A master set of current revision original documents needs to be kept in a secure, restricted location (both paper and electronic).
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 “controlled document” should be used to physically 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 document 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 easier to manage through user read-only access to job-specific controlled documents as long as employee terminals are available wherever the documents are needed. High-level documents, such as the quality manual and ISO specifications, need to be included in the document control system, serialized, and have limited distribution.
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 include: “Any customer or employee desiring a procedure 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 handle this is to add a timestamp to the document footer. A date and time will print on the document with an expiration date (e.g., 24 hours), after which the document becomes obsolete.
No Handwritten Notes/Changes
This is another area where many companies get busted, with forms and logs being the usual suspects. The system should be set up to not allow any form of manual handwritten changes. 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 permanent, etc.), and presents an open invitation to be abused. The “no handwritten notes/changes” clause needs to be specifically written into the document control procedure and requires discipline to become part of the culture.
The document control procedure needs to address electronic data (quality system files, customer data files, CAD files, business files, etc.) and specify not only a backup plan but also provide for redundant copies to be stored off-site for protection against a facility disaster. On-site copies should be securely stored, such as in a locked fire-proof safe. Cloud services have become the new standard for data backup, but it is good business practices (and cheap insurance) to still have a physical copy stored offsite.
While documentation is often viewed as a necessary evil, it is a very important aspect of any quality system. By adopting the “if you can’t prove it, it didn’t happen” mentality and applying the practical KISS principles discussed in this two-part series, a world-class, auditor-friendly documentation system can be developed with minimum pain and suffering.
Read Part 1, which originally appeared in the November 2020 issue of PCB007 Magazine.
This column originally appeared in the December 2020 issue of PCB007 Magazine.