Good day Sonja,
In regard to your question, do you mean by a 'revision interval' is establishing a review of materials, components, or devices on a routine basis for compliance with these regulations? The REACH regulation actually gets updated fairly often with new or revised materials being added, updated, or removed from the list. Typically when a device is revised or changed, the change order process would include an assessment of materials which may be impacted by RoHS, REACH, substances of concern, etc. Such as if a material or component (like a PCB board) were changed, then an assessment would be made if any of these requirements would be impacted. Then on a routine basis maybe every 6 months, 12 months or 24 months, depending on the classification, risk, or type of device, would be an assessment of the actual regulations to determine if anything new was added which may impact existing products. This routine review would be part of "new or revised regulatory requirements" which organisations can conduct periodically - typically part of an ISO 13485 quality management system as this is shown in the standard.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 22-Jul-2022 17:36
From: Sonja McClennen
Subject: Revision intervals for regulatory statements
I am seeking opinions on "best practice" for establishing revision intervals for two types of product statements:
1) compliance with a regulation that does not regularly update, such as RoHS (REACH and Prop 65 by nature require regular compliance statement updates)
2) presence/absence of a substance of concern, such as Bisphenol A, Latex, etc.
I'd appreciate any guidance.
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Sonja McClennen
Southampton PA
United States
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