Today, we will talk about understanding the control of documented information and learn how to respond to element 7 5 3 2 Control of documented information.
The clause reads:
• For the control of documented information, the organization shall address the following activities, as applicable:
• a) distribution, access, retrieval and use;
• b) storage and preservation, including preservation of legibility;
• c) control of changes (e.g., version control); and d) retention and disposition.
Point A, Distribution, Access, Retrieval, and Use we discussed in the previous video. Point C, control of changes, we covered in 7 5 2 video 7. Both links to these videos are in the description below – check them out. Let’s talk about point B, storage and preservation. Many companies retain most of their documents and records on electronic media. However, some businesses still keep particular records in hard copy format. Often, my clients store records in the department file cabinets. After a year or so, they put them in boxes and keep them in the warehouse.
Okay, looks like we addressed the storage of documented information here, but do these locations reliably preserve the records? No, anybody can find needed records in the department file cabinet and forget to return them. Warehouse is another set of concerns. Is a roof leak or a fire a probability? Is your business located in a region at risk of tornados or hurricanes? When I see these types of storage of records, I always ask the clients if they performed risk assessments. Surprisingly, the typical answer is no. The test is simple: What if you lose all or part of the records tomorrow? How will it affect your business? What about regulatory and statutory compliance? This is all about understanding control of documented information.
Regretfully, very few companies have plans for the worst-case scenarios. The solution is simple – electronic records maintained on the network or cloud for the life of business. Nowadays, with technological advances, it appears to be a simple task. One of my customers purchased two inexpensive scanners and placed them in the receiving and shipping areas. As soon as the process was complete, folks scanned hard-copy papers and placed them on the network.
However, you shall define the location and retention times if customer or regulatory requirements exist to retain hard-copy records. The good news is that we have already developed and discussed a BMS Structure that we can use for this purpose. If you missed that video, find the link below to video 7 5 3 1 Control of Documented Information.
Now, let’s move on to retention and disposition. Many businesses address this requirement by creating a Records procedure that usually blindly copies the standard and lists different records with their retention times. It appears that all these records procedures are overkill and a waste of time and paper because: firstly, the standard does not require a procedure for documented information or records. Secondly, if you need to keep records for different times, you can document them in the BMS Structure. Another option is to make all retention times the same and forget about both the procedure and the retention schedule unless you have specific industry or regulatory record retention requirements. I hope this video added to understanding control of documented information and helped you to better structure your documentation system.
This is all for today folks. Let's summarize our discussion:
• Consider one record retention period when possible.
• If retention times differ, document them in the Business Management System Structure.
7.5.3.1 - Distribution, Access, Retrieval and Use
• How to Control Documented Information Exam...
7.5.2 (7) – Control of Changes
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7 5 3 1 Control of Documented Information
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