In a muddle

[Bubbles80]

I am trying to design a retro fit QMS and my senior members are getting me in a muddle. Please someone help me

so i have a SOP - procedure, related to the procedure are Forms - which are attachments related to the parent procedure. eg Quality manual has quality policy and objectives as separate forms

SOP-Q01 - Quality manual , this is recorded as a V-01
SOP-Q01-A01 Quality policy and Q01-A02 Quality objectives these are kept as record - YYYYMMDD

then you have more procedures such as risk assessment SOP-G01 Risk assessment procedure with which you have 3 attachments plan, assessment and report, which all are templates

when completed plan is YYMMDD risk assessment is V1 and report is V1

its is driving me mental. I am trying to keep some control over the template to be used.

A further example is a product stability studies
Plan v1
distribution yyyymmdd
protocol v1
record yyyymmdd

Can you see where the confusion is occurring.

 

[Randy]

Starting to look like a "Rube Goldberg" influenced document design.

Rube Goldberg - Wikipedia

en.wikipedia.org

 

[Big Jim]

It is overly complex. Look for a simpler answer.

 

[yodon]

Absolutely agree with the sentiments already expressed... BUT, is it working for you? Change can be disruptive (and yes, possibly for the better). Are all documents and records uniquely identified? Generally, documents are expected to be revised so the revision identifier is most useful. Records are snapshots (yes, in some cases they can be revised) so a date is often used. Being consistent, of course, helps.

 

[Randy]

Change can be disruptive

Change will be resisted however as some of my favorite people say it........."Resistance is futile"

 

[Bev D]

Thanks Yodon. I am struggling with what is so confusing here…a well crafted form and template can be extremely useful. And version numbers are also valuable. So what exactly is the issue?

 

[ScottK]

I am trying to design a retro fit QMS and my senior members are getting me in a muddle. Please someone help me

so i have a SOP - procedure, related to the procedure are Forms - which are attachments related to the parent procedure. eg Quality manual has quality policy and objectives as separate forms

SOP-Q01 - Quality manual , this is recorded as a V-01
SOP-Q01-A01 Quality policy and Q01-A02 Quality objectives these are kept as record - YYYYMMDD

then you have more procedures such as risk assessment SOP-G01 Risk assessment procedure with which you have 3 attachments plan, assessment and report, which all are templates

when completed plan is YYMMDD risk assessment is V1 and report is V1

its is driving me mental. I am trying to keep some control over the template to be used.

A further example is a product stability studies
Plan v1
distribution yyyymmdd
protocol v1
record yyyymmdd

Can you see where the confusion is occurring.

I've never kept the quality policy and objectives as records. They have been documents themselves.

in the other example - this is how I do it: the templates are revision controlled controlled documents with unique IDs. They are a process input to the procedure or work instruction they are related to. The filled out template is the process output and becomes a record. Every risk assessment is assigned a unique ID.

Like so:


All that being said, I would probably not have three separate templates for risk assessment. I'd probably make it on document.

 

[Bubbles80]

I have sorted the mess out and done away with Yymmmdd and using version 1 etc control the templates