By the way, here is an excerpt from a prior Forum post I gave a couple years ago on this topic:
"...I distinguish between quality objectives needed to met applicable regulatory vs. those needed to meet requirements for product. This is because there is a distinct difference between regulatory requirements (such as FDA's 21 CFR Part 807 establishment registration) and the requirements in a standard, such as the quality management system (QMS) requirements in ISO 13485.
Sometimes, the quality objectives needed to meet applicable regulatory requirements may be as simple as assuring that the establishment is reregistered with FDA by 12/31/YYYY each year. Other times more sophisticated objectives will be relevant, such as achieving conformity with Europe's Regulation 2017/745 by a certain date.
In contrast, quality objectives needed to meet requirements for product are typically focused on product-specific or product QMS-specific topics, such as achieving specified resolution deadlines for Gizmo X complaints, reducing in-process Gizmo Y nonconformities, reducing the rate of complaints (alleged deficiencies) for Gizmo Z issue X, etc.
By the way, I recommend staying away from objectives aimed at reducing audit findings or CAPAs, as that tends to foster a cat-and-mouse culture.
Overall, be sure each quality objective is unambiguous, measurable, deadlined, meaningful, and feasible/realistic..."
------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
------------------------------
Original Message:
Sent: 13-Sep-2023 12:17
From: Kevin Randall
Subject: Regulatory requirements-quality objectives
The requirements for quality objectives in, for example, ISO 13485:2016, distinguish objectives for meeting applicable regulatory requirements from objectives for product requirements. I would say your example would be better applied regarding the latter type (product requirements).
Notwithstanding my prior narratives in this Forum about quality and regulatory being inseparable sides of the same coin, objectives related to meeting applicable regulatory requirements should be more topically focused on pure regulatory requirements. For example, proper completion of periodic registration renewals; proper resolution of outstanding regulatory citations (if any); etc., etc.
------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 12-Sep-2023 15:23
From: Anonymous Member
Subject: Regulatory requirements-quality objectives
This message was posted by a user wishing to remain anonymous
Hello,
Could anybody provide examples of quality objectives that meet regulatory requirements?
Is a quality objective of satisfied customers, to achieve a score of, e.g., 80% based on the customer satisfaction survey, applicable to the above?
Thank you!