Regulatory Open Forum

We are introducing a new position where there will be a QC technician required to support the production of medical devices. However, there is some disagreement on who this person should report to. QA want this person to report directly to them while production want this person reporting to them. Is there anything regulations wise or based on FDA feedback or observations to force this person to report to QA and not production
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LG - Regulatory Affairs Specialist
Ireland
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Traditionally, QC is part of production.  It is production's way of controlling the quality of its shipped output.  It tests product coming off the line so that defective product can be pulled and reworked as needed to meet specs, or scrapped.  QC is an homage to fallibility.  The better the production system, the less QC is needed.  Since no production system will ever be perfect, QC will always be needed.  QC is the function that inspired "You can't test quality into a device."  This does not mean QC serves no purpose; it means that QC will never improve the quality of what is coming off the line.  QC has responsibility for the quality of shipped product, but not for manufactured product.  QC TESTS PRODUCT for compliance with quality specs; it does not conduct quality audits.

Traditionally, QA is an independent entity that ASSURES (not ensures) quality.  That is to say, QA conducts audits to determine the level of quality that results from the production process and reports the results of its audits to management.  There ends the QA function.  Its independence is not just a location on an org chart. QA itself has NO responsibility for quality.  That is what makes its independence meaningful. It would undermine QA's independence for a position with quality responsiblity to be part of QA.  Then QA would be auditing itself.

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Julie Omohundro RAC
RAQA Services
Research Triangle Park NC
United States
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Original Message:
Sent: 11-20-2013 08:45
From: L Guinane
Subject: QC technician - reporting structure


We are introducing a new position where there will be a QC technician required to support the production of medical devices. However, there is some disagreement on who this person should report to. QA want this person to report directly to them while production want this person reporting to them. Is there anything regulations wise or based on FDA feedback or observations to force this person to report to QA and not production
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LG - Regulatory Affairs Specialist
Ireland
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I have worked with many organizations where QC reported to Manufacturing or QA.  In some large companies QC is a department in its own right.  Any of these approaches will work as long as the QC function is independent (and not influenced) by the Manufacturing or any other function.  As long as you can clearly demonstrate QC independence to a regulatory investigator, you should be all right.  

I would suggest that you read Acceptance Activities (Subpart H) and Management Responsibilities (820.20 (b)) of the US QSR regulation (21 CFR 820) and ensure you have the procedures in place to define the roles and responsibilities of your QC function. 

Note: All postings by me on this forum represent my personal views and are not necessarily the views of Prometheus Laboratories, Inc.   Further, my comments are intended to sharing of general knowledge.

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Larry Breite
Sr. Quality Systems Engineer
Prometheus Laboratories Inc.
San Diego CA
United States
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Original Message:
Sent: 11-20-2013 10:50
From: Julie Omohundro
Subject: QC technician - reporting structure

Traditionally, QC is part of production.  It is production's way of controlling the quality of its shipped output.  It tests product coming off the line so that defective product can be pulled and reworked as needed to meet specs, or scrapped.  QC is an homage to fallibility.  The better the production system, the less QC is needed.  Since no production system will ever be perfect, QC will always be needed.  QC is the function that inspired "You can't test quality into a device."  This does not mean QC serves no purpose; it means that QC will never improve the quality of what is coming off the line.  QC has responsibility for the quality of shipped product, but not for manufactured product.  QC TESTS PRODUCT for compliance with quality specs; it does not conduct quality audits.

Traditionally, QA is an independent entity that ASSURES (not ensures) quality.  That is to say, QA conducts audits to determine the level of quality that results from the production process and reports the results of its audits to management.  There ends the QA function.  Its independence is not just a location on an org chart. QA itself has NO responsibility for quality.  That is what makes its independence meaningful. It would undermine QA's independence for a position with quality responsiblity to be part of QA.  Then QA would be auditing itself.

-------------------------------------------
Julie Omohundro RAC
RAQA Services
Research Triangle Park NC
United States
-------------------------------------------






Original Message:
Sent: 11-20-2013 08:45
From: L Guinane
Subject: QC technician - reporting structure


We are introducing a new position where there will be a QC technician required to support the production of medical devices. However, there is some disagreement on who this person should report to. QA want this person to report directly to them while production want this person reporting to them. Is there anything regulations wise or based on FDA feedback or observations to force this person to report to QA and not production
-------------------------------------------
LG - Regulatory Affairs Specialist
Ireland
-------------------------------------------

I've seen all kinds of issues under the similar circumstances.

Pursuant to 21 CFR Section 820.20(b), the key is to provide and enforce "independence" between functional groups, which depends upon the size of an organization as well.

QC v Manufacturing (M)
QC v. QA

If QC reports to M, there is some potential for an increased risk of discretionary abuse. 
If QC reports to QA, the potential risk is rather reduced mainly because of increased awareness and familiarity of quality matters. 

Under the hypothetical scenarios and assuming we are talking about the same lots or batches, if QC reports to M, all lots or batches may meet the specs and almost no conforming products may be identified and reported.  If QC reports to QA, there may be at least few nonconforming products identified.
      

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Original Message:
Sent: 11-20-2013 10:42
From: L Guinane
Subject: QC technician - reporting structure


We are introducing a new position where there will be a QC technician required to support the production of medical devices. However, there is some disagreement on who this person should report to. QA want this person to report directly to them while production want this person reporting to them. Is there anything regulations wise or based on FDA feedback or observations to force this person to report to QA and not production
-------------------------------------------
LG - Regulatory Affairs Specialist
Ireland
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