Procedure Writing, Management Review and DXOs Explained
Procedure Writing
Summary
Structuring a document is an art-form, all too often do we see poorly laid out documents that lead to difficulty for the users to follow and as a result they struggle to use it as a point of reference. Additionally, documents are all too often used as a tick-box as opposed to something to benefit their business.
To decide whether you need to document something, here are two questions that should help you determine:
Is this a mandatory requirement from the standards you work to? For example, ISO 13485 mandates that you have a Quality Policy.
If you did not write this down, can AND would it be done the same each and every time?
If you do have to document an activity, there are a couple of things you want this to include:
Purpose
Scope
Reference Documentation
A general section - to provide context to the reader
Lifecycle approach - when designing a process it helps to think about how it initiates, what happens in the middle and how it concludes
Monitoring & measurement - what will the organisation monitor to check the effectiveness of the process
Records - a summary of the records generated as a result of the activities defined in the document.
➕ Additional Information: Checklist of mandatory documentation for ISO 13485, Document template
Management Review
Summary
A mandatory requirement part of any Quality Management System is Management Review.
There are no hard and fast rules for management review, the only requirements are that they are conducted at planned intervals and that it evaluates the continuing suitability, adequacy and effectiveness of a QMS upon whatever standard you work to.
Let’s say you work to ISO 13485 for this example. The standard very clearly maps out what management review shall include, here are a few of the shalls:
Feedback
Complaint handling
Reporting to regulatory authorities
Audits
Monitoring and measurement of processes
So, an easy way is to take the criteria that the standard lays out, and create a checklist as your management review agenda.
Again, nothing specifies you have to do management review monthly, bi-monthly etc., it just has to be planned (in your procedure for example).
➕ Additional Information: Management Review Agenda Checklist, Management Review Procedure
Documents of External Origin (DXO)
Summary
This is an area which we see organisations regularly getting caught out. But fear not!
Documents of External Origin or also known as DXOs, are exactly what they say on the tin. Examples of these are:
Standards such as ISO 9001 or ISO 13485
Maintenance manuals for equipment
Supplier certifications
Even though these aren’t in your control, they still form important inputs to your business, so it is imperative you have a process to manage them.
For the examples we identified, here are some controls you could have to manage them:
Standards such as ISO 9001 or ISO 13485 - you can subscribe to a standards website such as SAI which will always give you the most up to date standard.
Maintenance manuals for equipment - you could control these through your document control procedure and allocate review periods.
Supplier certifications - these could be managed through supplier re-evaluations or through your document control system.
A really nice and simple way is to have a spreadsheet register of DXOs. Check out the link below for a basic template and here is a fantastic blog on controlling documents of external origin
🔗 Additional Information: DXO register