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Something between a manual and a procedure?

#1
Hi folks. I’m working to redefine our doc structure /definitions and while I’m comfortable with procedures, WI’s, quality manual, I do have one struggle area.
We have a quality policy (High level statements), a quality manual structured by iso13485 (it works for us) which references procedures.

The area I’m looking into is a document type that describes the many procedures which cover the lifecycle of a process. For example, the supplier management lifecycle. Rather than all the procedures referenced in the quality manual, we have “procedures” which are actually a list of all the procedures that cover the full lifecycle.

Is there a document type for this? Am I over thinking it??
Thanks!
 
#2
You're overthinking it. I'm not even sure what you're asking. To me, you have a process, which contains several procedures. So, for example, you have a Purchasing process. Under that process, you have all the procedures (or sub-processes) that make up how you purchase something -- from supplier selection to ordering to receiving. Something like that.
 

Jim Wynne

Super Moderator
#3
Hi folks. I’m working to redefine our doc structure /definitions and while I’m comfortable with procedures, WI’s, quality manual, I do have one struggle area.
We have a quality policy (High level statements), a quality manual structured by iso13485 (it works for us) which references procedures.

The area I’m looking into is a document type that describes the many procedures which cover the lifecycle of a process. For example, the supplier management lifecycle. Rather than all the procedures referenced in the quality manual, we have “procedures” which are actually a list of all the procedures that cover the full lifecycle.

Is there a document type for this? Am I over thinking it??
Thanks!
As with Golfman25, I'm not sure what you're asking. What is the "supplier management lifecycle" and how does it differ from defining how supplier management must be done?
 
#4
Let me explain further...the supplier lifecycle has procedures for supplier selection, classification, ongoing monitoring and part obsolescence. Each is an element on the process but it’s own procedure.
How do I document the lifecycle and connection of those procedures so it’s easy for an employee (or auditor) to navigate to the right procedure for the sub process they need.
 

Ajit Basrur

Staff member
Admin
#5
Let me explain further...the supplier lifecycle has procedures for supplier selection, classification, ongoing monitoring and part obsolescence. Each is an element on the process but it’s own procedure.
How do I document the lifecycle and connection of those procedures so it’s easy for an employee (or auditor) to navigate to the right procedure for the sub process they need.
First, to refresh, the Quality Manual describes the quality management system in accordance with the stated quality policy and objectives, while the Procedures describe the interrelated processes and activities required to implement the quality management system.

It is in those procedures that the interrelationships are provided so that the cross-functional groups understand it and help employees to understand their role within the organization, thus giving them an increased sense of purpose and importance of their work.

You could refer to ISO/TR 10013, Guidelines for quality management system documentation, to understand more about quality system documentation.
 

Watchcat

Involved In Discussions
#6
The area I’m looking into is a document type that describes the many procedures which cover the lifecycle of a process. For example, the supplier management lifecycle. Rather than all the procedures referenced in the quality manual, we have “procedures” which are actually a list of all the procedures that cover the full lifecycle.
Thanks!
Are you saying you want something above and beyond the "procedures" that are simply a list, one which describes those procedures and/or how they are interrelated?
 
#7
Are you saying you want something above and beyond the "procedures" that are simply a list, one which describes those procedures and/or how they are interrelated?
Yes but not at the highest level. For example, supplier management in interwoven through management, design control, production control, outsourced processes. My quality manual is ordered by the sections of iso13485, so the elements of supplier management weave through it.

What I’d like is something to sit under the quality manual but above the sub process procedures which ties than all together.
 

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#9
We have a high level SOP that instructs us to meet with purchasing and sort of audit each supplier - are we using them? Do we need to? How are they performing?

By doing this audity type activity the lifecycle falls in place.
 

Tagin

Involved In Discussions
#10
Let me explain further...the supplier lifecycle has procedures for supplier selection, classification, ongoing monitoring and part obsolescence. Each is an element on the process but it’s own procedure.
How do I document the lifecycle and connection of those procedures so it’s easy for an employee (or auditor) to navigate to the right procedure for the sub process they need.
I would think of it in terms of the nature of the question/uncertainty that the employee has that is driving this need: how can you structure the information in a way that is most expedient/useful/intuitive to answering their questions/uncertainty?

You've indicated these separate but related areas:
  • supplier selection
  • classification
  • ongoing monitoring
  • part obsolescence
These seem like elements of a PDCA cycle:
  • PLAN - supplier selection / classification
  • DO - order/receive parts, receive lifecycle status updates, etc.
  • CHECK - ongoing monitoring (is the supplier performing? Are they communicating part lifecycle status?)
  • ACT - part obsolescence (what do we do when are part is going EOL or has gone EOL?)
So PDCA might be a useful paradigm for documenting these separate aspects of the supplier lifecycle as one meaningful process.
 
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