Regulatory Open Forum

Do you have to reference all regulatory standards that apply to your procedure within each procedure or can you just have a table that references the correlation between standards in your quality manual?

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Melissa Basnight RAC
Zest Anchors
Escondido CA
United States
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As far as I am aware, there is nothing in a regulation or quality system standard that specifies how you are to manage the relationship between procedures and applicable standards.  This gives you a lot of flexibility to define a system for your company.
When I was working for a large company it was suggested to us by an auditor from our registrar that instead of referring to applicable regulations and standards in our procedures, we should reference the regulations and standards in the manual and reference the manual in the procedures.  There is certainly a value in having a single source for the information, since it is then more straightforward to keep up to date. 
Ultimately, however, you need to make your decisions based on what is going to work in your context.  For example, if the people using a procedure never bother to refer to the table you create for tracking the standards, then that approach will not work in your organization.
If you define your system and can convince yourselves it is working, you will be able to convince any external party.

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William White
Senior Consultant
Quality System Strategies LLC
Elkhart IN
United States
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Original Message:
Sent: 08-02-2013 18:16
From: Melissa Basnight
Subject: Procedure references

Do you have to reference all regulatory standards that apply to your procedure within each procedure or can you just have a table that references the correlation between standards in your quality manual?

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Melissa Basnight RAC
Zest Anchors
Escondido CA
United States
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In procedures and SOPs I prefer to use the term "Applicable" Document and Standards rather than the term
 " Reference Documents".  When we create the list of Applicable Documents in a procedure we should include in the list only documents (internal and customer), standards and regulations which are actually mentioned in the text of procedure. The procedure requires to something according to the applicable document. This means for the user of the procedure that in order to understand it fully he needs to have immediate access to the applicable documents. Sometimes I see in procedures a very large list of reference standards and regulations which are not actually mentioned in the SOP. In this case this list is more like a bibliography list showing that the author is familiar with a lot of standards and regulations.

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Gadi Shtepel
Gadi Shtepel Ltd.
Sgula
Israel
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Original Message:
Sent: 08-03-2013 08:13
From: William White
Subject: Procedure references

As far as I am aware, there is nothing in a regulation or quality system standard that specifies how you are to manage the relationship between procedures and applicable standards.  This gives you a lot of flexibility to define a system for your company.
When I was working for a large company it was suggested to us by an auditor from our registrar that instead of referring to applicable regulations and standards in our procedures, we should reference the regulations and standards in the manual and reference the manual in the procedures.  There is certainly a value in having a single source for the information, since it is then more straightforward to keep up to date. 
Ultimately, however, you need to make your decisions based on what is going to work in your context.  For example, if the people using a procedure never bother to refer to the table you create for tracking the standards, then that approach will not work in your organization.
If you define your system and can convince yourselves it is working, you will be able to convince any external party.

-------------------------------------------
William White
Senior Consultant
Quality System Strategies LLC
Elkhart IN
United States
-------------------------------------------






Original Message:
Sent: 08-02-2013 18:16
From: Melissa Basnight
Subject: Procedure references

Do you have to reference all regulatory standards that apply to your procedure within each procedure or can you just have a table that references the correlation between standards in your quality manual?

-------------------------------------------
Melissa Basnight RAC
Zest Anchors
Escondido CA
United States
-------------------------------------------

I think that you could do both. At the company I work for we have a document that lists all the standards that we maintain compliance to along with a table that shows the linkage between the CFR and ISO. Then in all our documents we say see that procedure for the standards that we comply to.

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Keri Froese RAC
Quality Assurance Specialist
Ottawa ON
Canada
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Original Message:
Sent: 08-02-2013 18:16
From: Melissa Basnight
Subject: Procedure references

Do you have to reference all regulatory standards that apply to your procedure within each procedure or can you just have a table that references the correlation between standards in your quality manual?

-------------------------------------------
Melissa Basnight RAC
Zest Anchors
Escondido CA
United States
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Depends on where you're marketed and who's auditing you.
CMDCAS requires procedures to be referenced within the OP to which they pertain.
Other regulators are no so specific.
We do as Keri's organization does; we cite all applicable Regs and External Stds to which we comply in our overarching Quality Plan with correlation from geography to geography (i.e., FDA compared to MEDDEV, R59, CMDR, etc.; we then also cite the appliable Reg(s) and Std(s) in each procedure.
What we do NOT do is copy the Reg or Std into our OPs, as this creates a document maintenance burden each time a Reg or Std changes.
Our Quality Policy requires we always refer to the current version of the applicable Reg/Std for the activity being done.
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Aimée Campbell
Abbott Vascular
Menlo Park CA
United States
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Original Message:
Sent: 08-06-2013 08:44
From: Keri Froese
Subject: Procedure references

I think that you could do both. At the company I work for we have a document that lists all the standards that we maintain compliance to along with a table that shows the linkage between the CFR and ISO. Then in all our documents we say see that procedure for the standards that we comply to.

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Keri Froese RAC
Quality Assurance Specialist
Ottawa ON
Canada
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Original Message:
Sent: 08-02-2013 18:16
From: Melissa Basnight
Subject: Procedure references

Do you have to reference all regulatory standards that apply to your procedure within each procedure or can you just have a table that references the correlation between standards in your quality manual?

-------------------------------------------
Melissa Basnight RAC
Zest Anchors
Escondido CA
United States
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