Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​Hello Everyone,

I am creating a system to track all of our compliance letters - REACH, RoHs, PROP 65, CMR, BSE/TSE etc.
Can someone share how they track all their certs (no software suggestions please) and also if there are timelines to when these certs expire?
I have had some companies send me these certs with validity on them while some don't. Does the company define the validity on them or we can create a system to define the timeline on these?
Can someone help how I can define the timeline on these documents? For example, REACH and RoHs list gets frequently updates so an annual update of these documents seem appropriate while PROP65, animal/human derivative or conflict minerals can be every two years? I can set these timelines for our internal purposes but just want to ensure if there's a guidance related to these.

Thank you!

Hello Anon,

I remember the daunting task of tracking and keeping tracking of all the regulatory letters, notifications, certificates, documents, etc., which ended up in some file folder in my desk.  Then the problem was when I needed to find something it was a bit difficult especially if something I had not touched for a time.  More was when I came into a new job and trying to find certain letters or documents was always a treasure hunt which sometimes never found the pot 'o gold and had to re-register products or create a new document.  To help with this, I had created a simple spreadsheet which evolved over time with some basic columns such as Region, Document Type (guidance, letter), Expiration Date, Short Description, and the File Location.  I then kept a file location which eventually migrated to a central file folder on the server which eventually I started assigning document identification numbers to keep track (also keep it in the QMS system as an "external origin" document).  To help facilitate keeping everything up to date, I established a process (and procedure) for conducting routine reviews of these files and keeping track of expiration dates.  Rather than doing it once a year which was daunting some times, I set aside some time each month to go through the list and keep things up to date, as well as add new information since there were always new guidance, new certificates, or changes being made.  This is all about Regulatory Intelligence where there are some nice papers from RAPS and others on this, but I personally think there is just not one way to complete Regulatory Intelligence.  Depending on your organisation, device type, markets you are selling in, there can be a simple or complex way to keep track of intelligence which should be specific to your needs.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 15-Dec-2020 11:00
From: Anonymous Member
Subject: Compliance letters and timeline

This message was posted by a user wishing to remain anonymous

​Hello Everyone,

I am creating a system to track all of our compliance letters - REACH, RoHs, PROP 65, CMR, BSE/TSE etc.
Can someone share how they track all their certs (no software suggestions please) and also if there are timelines to when these certs expire?
I have had some companies send me these certs with validity on them while some don't. Does the company define the validity on them or we can create a system to define the timeline on these?
Can someone help how I can define the timeline on these documents? For example, REACH and RoHs list gets frequently updates so an annual update of these documents seem appropriate while PROP65, animal/human derivative or conflict minerals can be every two years? I can set these timelines for our internal purposes but just want to ensure if there's a guidance related to these.

Thank you!

This message was posted by a user wishing to remain anonymous

​Thank you, Richard!
You are right! It all depends on the complexity of documents that were I was bumping into. We don't have a lot of products rather lot of suppliers and components to build a tracker around it. It's fairly easy yet complex as all documents sometimes received may have different expiration timeline for example, RoHs and REACH are updated quite frequently while Prop 65 or conflict Minerals can last for few years. Some companies send us documents with validity on them while some don't and so we need to define a timeline to when we need to routinely update these Certs. As you mentioned we have a lot of different types of Certs, some specific to EU requirements and some specific to State but as of now we have learned that there are only a few that we currently required by our customers to provide compliance, which is mostly to REACH, RoHS, MDR and animal/human free.
Original Message:
Sent: 16-Dec-2020 03:07
From: Richard Vincins
Subject: Compliance letters and timeline

Hello Anon,

I remember the daunting task of tracking and keeping tracking of all the regulatory letters, notifications, certificates, documents, etc., which ended up in some file folder in my desk.  Then the problem was when I needed to find something it was a bit difficult especially if something I had not touched for a time.  More was when I came into a new job and trying to find certain letters or documents was always a treasure hunt which sometimes never found the pot 'o gold and had to re-register products or create a new document.  To help with this, I had created a simple spreadsheet which evolved over time with some basic columns such as Region, Document Type (guidance, letter), Expiration Date, Short Description, and the File Location.  I then kept a file location which eventually migrated to a central file folder on the server which eventually I started assigning document identification numbers to keep track (also keep it in the QMS system as an "external origin" document).  To help facilitate keeping everything up to date, I established a process (and procedure) for conducting routine reviews of these files and keeping track of expiration dates.  Rather than doing it once a year which was daunting some times, I set aside some time each month to go through the list and keep things up to date, as well as add new information since there were always new guidance, new certificates, or changes being made.  This is all about Regulatory Intelligence where there are some nice papers from RAPS and others on this, but I personally think there is just not one way to complete Regulatory Intelligence.  Depending on your organisation, device type, markets you are selling in, there can be a simple or complex way to keep track of intelligence which should be specific to your needs.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 15-Dec-2020 11:00
From: Anonymous Member
Subject: Compliance letters and timeline

This message was posted by a user wishing to remain anonymous

​Hello Everyone,

I am creating a system to track all of our compliance letters - REACH, RoHs, PROP 65, CMR, BSE/TSE etc.
Can someone share how they track all their certs (no software suggestions please) and also if there are timelines to when these certs expire?
I have had some companies send me these certs with validity on them while some don't. Does the company define the validity on them or we can create a system to define the timeline on these?
Can someone help how I can define the timeline on these documents? For example, REACH and RoHs list gets frequently updates so an annual update of these documents seem appropriate while PROP65, animal/human derivative or conflict minerals can be every two years? I can set these timelines for our internal purposes but just want to ensure if there's a guidance related to these.

Thank you!