If you are writing policies and procedures documentation, then at some point you will need to answer the question “How Effective are Policies and Procedures?” If you can measure your documentation against some common elements, then you will have a method for managing, reviewing, and communicating the effectiveness of your policies and procedures. Continue reading How Effective are Policies and Procedures?
The ISO 9001:2015 quality standard has a number of documentation requirements and specifically calls out 7.5 Documented information, which replaces 4.2.3 Control of Documents and 4.2.4 Control of Records in the previous ISO 9001:2008. To understand the difference, first let’s clarify the difference between documents and records. Continue reading What Is the Difference Between Document Control and Record Control?
When many of us see change coming, we’re not sure what to do. We sometimes fear or mistrust change, or we put off big problems because they’re “too much all at once”, and we stick with outdated, inefficient tools, methods, and processes.
We sense that the way we go about developing procedures isn’t producing satisfactory results, yet we keep at it. We can’t afford to continue doing what we’ve been doing if we’re to remain competitive. So, how can you develop procedures quickly? Continue reading How to Develop Procedures Quickly
The Document Compliance Manager must manage all policies, procedures, work instructions, job aids, and compliance records to assure conformance with various standards and regulations. Continue reading What Are Document Compliance Manager Responsibilities?
Creating and maintaining a definitive set of policies and procedures represents a significant investment of resources. To make these activities as routine and painless as possible, organization are wise to establish a repeatable policy and procedure development process. It is by following this process that you can get policies and procedures ‘Done’. Continue reading How to Get Policies and Procedures ‘Done’
If your company is like most, you’re storing your policies and procedures on a file server. Perhaps your working drafts are in one folder, approved versions are in another folder, and previous versions are archived in yet another folder. Some companies will create folders for the different clauses of ISO 9001 or arrange documents according to functional areas or departments. A lot of these companies aren’t even practicing the most basic security techniques, like limiting “read-write” privileges to a select few. Furthermore, how can you use a document control system to manage your policies and procedures? Continue reading What Document Control System Is Most Effective?
Why are you writing a procedure? Most people write procedures to document their daily tasks so they can train others or comply with some requirement — kind of a “punch card” or “time clock” mentality. Others are documenting a process so they can produce better process results — a business process improvement mentality. These are two very different reasons for writing procedures and your answer defines the results you will get with your procedures. If you want to change your results then you need to change your thinking. So what’s the best way to document processes and procedures? Continue reading How to Document Processes and Procedures
There are many document control mistakes your company can make if not using document control software, but first off what is document control? Document control is required in order for a Quality Management System to be compliant with ISO 9001. The same is true for other standards, guidelines, and regulations — the U.S. Food and Drug Administration (FDA), Good Manufacturing Practices (GMP) , the Information Technology Infrastructure Library (ITIL), Sarbanes-Oxley (SOX), and many other laws and guidelines require that you have control over your documentation. Continue reading How to Reduce Document Control Mistakes with Document Control Software