Sunday, November 11, 2018

Let's talk about record control? How do you manage them?

Record control is a system how all records are kept and managed.  Record essentially is a completed forms that serve as evidence that process or task has been completed per given procedure.


This procedure is a compliment to Document Control process.
Record is a gain tedious but crucial in proving conformity during audits.  It is the OBJECTIVE EVIDENCE we talked so many time in my last post.
Record contain the following information:
  • A unique reference number as document identification
  • The record title (or suitable description of the form)
  • The location of the record. (office, on website link, production etc)
  • The retention period which applies (typically 3 years for quality record)
  • The person responsible for retaining the quality record (most probably process owner)









Friday, November 2, 2018

How to comply to Document Control procedure?

The thing we always see at work are lots of documentations and as if that's not enough, every year, the process get more complicated therefore requiring more documents.  My head just hurt thinking about  photos taking, words to clarify each steps in the instruction and not to mention, changes have to be made when someone thinks the document is not "good" enough.  I am exhausted, this is a hard article. After the documents are in tip top order, people would come back and say, nobody reads them anyway 🙄. Explain to me why we need documentation again?

We have documentation to comply to all the ISO requirement specifically clause 4.2.3.
Per ISO 9001:2015: Documentation Control Clause 4.2.3 tells us that an organization must control the documentation required by the Quality Management System and that a suitable document control procedure must be implemented to define the controls needed to; 

  • approve, 
  • review, 
  • update, 
  • identify changes, 
  • identify revision status and 
  • provide access. 

The document control procedure must clearly define the scope, purpose, method and responsibilities required to implement these parameters.

These information normally available readily in the title block.  Changes regards as history on very last page while the scope, purpose, method and responsibilities is found right after title block.  Typical this a template is useful to ensure consistency.