Regulatory Open Forum

Hello dear peers,

I need your expertise on one matter please.

Indeed, we are starting in our company to have more specific procedures for each administrative department, such as HR procedures, Finance procedures and a procedure related to the security of patient information.

And we wonder if these should be in the QMS for medical device manufacturing?
Should all these other procedures be controlled by the QMS or should they have their own management system?

If not, how should we control them please?

Thank you in advance for your guidance.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Hey Nadine.  In a nutshell, if an organization has, for example, a medical device ISO 13485 QMS and/or an FDA 21 CFR Part 820 medical device QMS, then any procedures (or other documentation) that are demanded by those authorities must be part of that QMS.  In contrast, general business policies don't need to be maintained in the medical device QMS.

For example, an organization's HR procedures for determining vacation/holiday time, or its Finance procedures for filing tax returns, need not be in the medical device QMS.  Yet in contrast, some HR procedures/documents (like regulated operation job descriptions for example), and some Finance procedures/documents (like device-related / quality-related purchasing procedures and documents for example), are generally required to be part of the medical device QMS documentation because such documents are required to be in the medical device QMS by, for example, ISO 13485 and/or FDA 21 CFR Part 820.

Since medical device QMS documentation is already overbearing enough when populated with just the minimum required by applicable QMS standard(s) or regulatory requirements, then I recommend against putting general business processes and documents under the medical device QMS.  Instead, the general business procedures and documents can, and in my opinion should, be kept separate.

Note that in such an approach, "kept separate" doesn't necessarily prevent you from leveraging aspects of the medical device QMS infrastructure, such as where a document control process would be of use for the general business documents.  For example, one may reasonably create and house general business documents in the same eQMS system, or make use of the same document control tools.  But such non-regulated documents should still be "kept separate" (e.g., physically, digitally, or by other means) from the regulated medical device QMS documents in order to avoid confusion and mix-ups with the medical device QMS documentation.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 22-Nov-2022 16:15
From: Nadine Adia
Subject: QMS procedure management

Hello dear peers,

I need your expertise on one matter please.

Indeed, we are starting in our company to have more specific procedures for each administrative department, such as HR procedures, Finance procedures and a procedure related to the security of patient information.

And we wonder if these should be in the QMS for medical device manufacturing?
Should all these other procedures be controlled by the QMS or should they have their own management system?

If not, how should we control them please?

Thank you in advance for your guidance.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Hello Nadine,

It may be quite common the functions or responsibilities Human Resources or Finance are completing in the company cross-over and have some activities within the medical device area, e.g. training for HR or purchasing for Finance.  There are many activities or functions these departments complete, which do not fall within a ISO 13485 or other medical device related requirements.  I agree with Kevin about the functions within the Quality Management System (QMS) and those which can be separate.  In some cases, procedures or work instructions are needed in HR or Finance due to other requirements, such as labour laws specific to country or State, and financial record keeping depending on private or public owned company.  Though as mentioned, these would be out of the "medical device QMS" and not shown to an auditor during a certification audit.  However, it does not mean you can not keep those procedures (if needed or appropriate) in the QMS, they just would not be shown or provided to an external auditor.  You may need to manage the audit carefully though because some processes are a bit grey in a QMS such as hiring personnel/new employee onboarding because this crosses into qualification and competency of employees.  Companies may say, "Nope, you can not review because those are HR," but in fact some of those procedures/instructions may be viewable.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 22-Nov-2022 16:58
From: Kevin Randall
Subject: QMS procedure management

Hey Nadine.  In a nutshell, if an organization has, for example, a medical device ISO 13485 QMS and/or an FDA 21 CFR Part 820 medical device QMS, then any procedures (or other documentation) that are demanded by those authorities must be part of that QMS.  In contrast, general business policies don't need to be maintained in the medical device QMS.

For example, an organization's HR procedures for determining vacation/holiday time, or its Finance procedures for filing tax returns, need not be in the medical device QMS.  Yet in contrast, some HR procedures/documents (like regulated operation job descriptions for example), and some Finance procedures/documents (like device-related / quality-related purchasing procedures and documents for example), are generally required to be part of the medical device QMS documentation because such documents are required to be in the medical device QMS by, for example, ISO 13485 and/or FDA 21 CFR Part 820.

Since medical device QMS documentation is already overbearing enough when populated with just the minimum required by applicable QMS standard(s) or regulatory requirements, then I recommend against putting general business processes and documents under the medical device QMS.  Instead, the general business procedures and documents can, and in my opinion should, be kept separate.

Note that in such an approach, "kept separate" doesn't necessarily prevent you from leveraging aspects of the medical device QMS infrastructure, such as where a document control process would be of use for the general business documents.  For example, one may reasonably create and house general business documents in the same eQMS system, or make use of the same document control tools.  But such non-regulated documents should still be "kept separate" (e.g., physically, digitally, or by other means) from the regulated medical device QMS documents in order to avoid confusion and mix-ups with the medical device QMS documentation.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 22-Nov-2022 16:15
From: Nadine Adia
Subject: QMS procedure management

Hello dear peers,

I need your expertise on one matter please.

Indeed, we are starting in our company to have more specific procedures for each administrative department, such as HR procedures, Finance procedures and a procedure related to the security of patient information.

And we wonder if these should be in the QMS for medical device manufacturing?
Should all these other procedures be controlled by the QMS or should they have their own management system?

If not, how should we control them please?

Thank you in advance for your guidance.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Hi Nadine,

I echo what Kevin stated about certain HR and Finance procedures.  We have job descriptions, hiring practices since they deal with competency (sited on an audit), vendor set-up and vendor management in our QMS. 

Since controlling documents is generally a good business practice, we have a different numbering system and control for our non-QMS documents.  There is no requirement for change approval or paperwork.  The owner of the document changes it themselves, and the documents are only controlled by a date, not a revision, to ensure that everyone is using the most current form.  We use an Excel Workbook to store the titles and dates of those WIs, charts, forms so that everyone can see the date of the most current revision.

Regards,

------------------------------
D Michelle Williams
VP - Operations
United States
------------------------------

Original Message:
Sent: 22-Nov-2022 16:58
From: Kevin Randall
Subject: QMS procedure management

Hey Nadine.  In a nutshell, if an organization has, for example, a medical device ISO 13485 QMS and/or an FDA 21 CFR Part 820 medical device QMS, then any procedures (or other documentation) that are demanded by those authorities must be part of that QMS.  In contrast, general business policies don't need to be maintained in the medical device QMS.

For example, an organization's HR procedures for determining vacation/holiday time, or its Finance procedures for filing tax returns, need not be in the medical device QMS.  Yet in contrast, some HR procedures/documents (like regulated operation job descriptions for example), and some Finance procedures/documents (like device-related / quality-related purchasing procedures and documents for example), are generally required to be part of the medical device QMS documentation because such documents are required to be in the medical device QMS by, for example, ISO 13485 and/or FDA 21 CFR Part 820.

Since medical device QMS documentation is already overbearing enough when populated with just the minimum required by applicable QMS standard(s) or regulatory requirements, then I recommend against putting general business processes and documents under the medical device QMS.  Instead, the general business procedures and documents can, and in my opinion should, be kept separate.

Note that in such an approach, "kept separate" doesn't necessarily prevent you from leveraging aspects of the medical device QMS infrastructure, such as where a document control process would be of use for the general business documents.  For example, one may reasonably create and house general business documents in the same eQMS system, or make use of the same document control tools.  But such non-regulated documents should still be "kept separate" (e.g., physically, digitally, or by other means) from the regulated medical device QMS documents in order to avoid confusion and mix-ups with the medical device QMS documentation.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 22-Nov-2022 16:15
From: Nadine Adia
Subject: QMS procedure management

Hello dear peers,

I need your expertise on one matter please.

Indeed, we are starting in our company to have more specific procedures for each administrative department, such as HR procedures, Finance procedures and a procedure related to the security of patient information.

And we wonder if these should be in the QMS for medical device manufacturing?
Should all these other procedures be controlled by the QMS or should they have their own management system?

If not, how should we control them please?

Thank you in advance for your guidance.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Hi Nadine
i suspect this question may be more about storage of records and procedural differences for HR, legal, finance and even clinical systems compared to engineering systems.

I also wonder about the benefit of keeping the systems processes in separate QMS systems. The risks seem pretty obvious: failure to follow, disorganization, confusion about which QMS to follow. On the other hand, using separate QMS systems happens all the time when you outsource to a third party with heir own QMS System. Sometimes the benefits are the separate QMS is more fit for purpose since the needs and audiences and word choices are so different (risk=device; risk=sufficient $; risk=patient health).

In the end this may come down to how the company wants to operate (as one entity or as several separate entities: Johnson and Johnson is a good example with over 200 operating companies). The separation may be corporate SOPS vs department or subsidiary company SOPs. 

if yours is a small single company the benefit of having one QMS may outweigh the risk of needing to manage and train to more than one QMS. Remember not all employees need to know every QMS component; we often train different roles/departments on different parts of our QMS and we may restrict who can access certain parts of our QMS on a need to know basis.

just a few ideas.

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Original Message:
Sent: 22-Nov-2022 16:15
From: Nadine Adia
Subject: QMS procedure management

Hello dear peers,

I need your expertise on one matter please.

Indeed, we are starting in our company to have more specific procedures for each administrative department, such as HR procedures, Finance procedures and a procedure related to the security of patient information.

And we wonder if these should be in the QMS for medical device manufacturing?
Should all these other procedures be controlled by the QMS or should they have their own management system?

If not, how should we control them please?

Thank you in advance for your guidance.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

It strikes me that the question is how to handle a variety of management systems. One of which is the quality management system. Others I have seen are health & safety, environmental, human resources, finance, and patient confidentiality (HIPPA in the US).

Each of these has distinct characteristics as well as characteristics in common (such as documented procedures).

My recommendation is to think about an overarching system for all of the management systems. Don't bring all into the QMS, but think of the QMS as one instance.

In a small company you will want to avoid duplication of effort. You might have, for example, one common system to control procedures, but reviewers and approvers are specific to each system.

Take the best aspects of each system, assuming you are implementing a law, regulation, or standard, and use them to make common systems that are both efficient and effective.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 22-Nov-2022 16:15
From: Nadine Adia
Subject: QMS procedure management

Hello dear peers,

I need your expertise on one matter please.

Indeed, we are starting in our company to have more specific procedures for each administrative department, such as HR procedures, Finance procedures and a procedure related to the security of patient information.

And we wonder if these should be in the QMS for medical device manufacturing?
Should all these other procedures be controlled by the QMS or should they have their own management system?

If not, how should we control them please?

Thank you in advance for your guidance.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Thank you all for these valuable response.
They were very helpful and it is clear now for us how we could manage the document not part of QMS based on ISO 13485.
Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Original Message:
Sent: 22-Nov-2022 16:15
From: Nadine Adia
Subject: QMS procedure management

Hello dear peers,

I need your expertise on one matter please.

Indeed, we are starting in our company to have more specific procedures for each administrative department, such as HR procedures, Finance procedures and a procedure related to the security of patient information.

And we wonder if these should be in the QMS for medical device manufacturing?
Should all these other procedures be controlled by the QMS or should they have their own management system?

If not, how should we control them please?

Thank you in advance for your guidance.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------