How does a Document Control procedure become weak?


A surprising proportion of Document Control professionals work without a procedure.


What is more surprising yet is that, among those who do have a procedure, a surprising proportion do not work by it, because it is not adapted to their actual day-to-day practices. In this case, let’s agree that this is the same as not having a procedure at all.


It is highly undesirable and discommended not to have a functional set of rules and procedures. After all, Document Control is a by essence a procedural profession. With no rules to defend, it makes no sense. Document Control with no rules to uphold is like the police with no law to uphold.


The absence of rules and procedures generates much stress for Document Control professionals, but so do existing procedures that are ill-adapted, out of date, weak or irrelevant.


Weak rules and procedures open the door to user resistance, sterile discussions and potentially harmful mistakes. How can you convince a user to proceed through a certain process if you have no process to show? How can you tell a user that their action is not compliant if you have no compliance reference?


But how do a set of rules and a procedure become weak, ill-adapted, out-of-date or irrelevant?


First, it appears that the initial set of rules was not complied with, if no one at any point realised that day-to-day practices were straying away from the ‘book’. 


A Document Control procedure should be always open, whether in hard-copy form on a desk, or electronically, so that Document Control professionals working by that procedure can refer to it day after day, all day.


Second, it appears that there is no periodic review of the applicability of the set of rules and the procedure. The best organisations review the applicability of their Document Control rules and procedures at least once a year. 


Every year, the question must be asked, for each section of the rules, for each process, for each section of the procedure: “Does it still match our day-to-day practices? Is it still applicable?”


If the answer is no, a further strategic question must be asked: “If the rules, the processes and the procedure no longer match our day-to-day practices, do we correct our practices, or do we modify the rules to reflect how we work now?” 


In any case, during this periodic review, action must be taken to ensure that the rules and day-to-day practices are the same, regardless of the selected strategy.


Third, it appears that there is no culture of Continuous Improvement (topic discussed in The Document Control Tribune, issue number 10, page 6 and in issue number 11, page 5). 


The best Document Controllers put into practice this culture wherein each Document Control incident, each learning opportunity and each improvement opportunity is discussed, logged, reflected on and integrated in the rules, the processes and the procedure. 


Consepsys Tips of the Month for September 2017 and March 2021 explore this culture further. A Continuous Improvement culture allows to never let a set of rules and a procedure become weak, ill-adapted, out-of-date or irrelevant.



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