• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Blog
  • News & Events
  • Videos
  • Resources
main-logo-small

Compliance Architects

Consulting Technology Outsourcing

  • About Us
    • Senior Staff
    • Why Us
    • Mission And Vision
    • Clients
    • Partners
    • Career Opportunities
  • Services
    • Inspection Readiness & Enforcement
      • FDA Inspection Readiness
      • Audits & Assessments
      • FDA Enforcement Response/Remediation
    • FDA Quality Consulting
      • Quality System & Compliance Turnarounds / Restructuring
      • Training / Coaching
      • Quality & Compliance Computer-Based Systems
      • External Supply Chain Compliance
      • Part 11 & Computer Systems Validation
      • Turnkey Quality Systems
    • Quality Assurance and Engineering
      • CRPN Quality Roadmap®
      • Quality Culture Assessment
      • Product Quality Consulting
      • Operational Efficiency/Compliance Effectiveness
      • Project/Program Management
    • Corporate Compliance and Litigation
      • Corporate Compliance Programs
      • Interactions With Department Of Justice And The Courts
    • FDA Regulatory Consultants
      • Product Development / Submissions / Commercialization
      • REMS (Risk Evaluation And Mitigation Strategies)
      • Mergers / Acquisitions / Licensing
    • Quality, Compliance, Regulatory & Operations’ Staffing
      • Staffing
      • Talent Management
      • Rapid Turnaround
  • Innovative Solutions
    • Writing for Compliance®
    • CRPN Quality Roadmap®
    • Quality Pulse®
    • IEEP
    • REMS
  • Success Stories
  • Industries
    • Biopharmaceuticals
    • Cannabis/CBD
    • Cell & Gene Therapies
    • Combination Products
    • Cosmetics
    • Dietary Supplements
    • Medical Devices and Diagnostics
    • Pharmaceuticals
  • Contact Us

Embracing “Quality” Over “Compliance” — A Misguided Approach to Improving FDA-Regulated Quality Outcomes

As someone with many years of experience working in and around FDA-regulated manufacturing operations, a recent LinkedIn post (March 2018) entitled “Why QUALITY Needs to STOP Working on COMPLIANCE” has really rankled me.   Unfortunately, this is not the first time this topic has been discussed.  There are frequent speakers these days berating “compliance” in favor of “quality.”

Despite how de rigueur it has become to embrace this premise, I remain unconvinced.

In fact, a discussion about Quality and Compliance is not a competition or an either/or proposition.    I believe strongly that it’s a dangerous message to refer to compliance as a non-value-added activity (an expense as the article referenced above stated) while referring to quality as some abstract panacea that magically occurs from some creative or innovative activity that is not being done because of the focus on “the bad compliance activities.”

I submit that this characterization is a gross oversimplification.

Medical Devices & PharmaceuticalsWhat IS QUALITY if not the activity that ensures conformance to defined requirements and expectations?  What IS COMPLIANCE if not the activity that ensures conformance to defined requirements and expectations?  The only difference is that, with respect to Quality, it’s patient, customer, and market-centric requirements and expectations that ensure therapeutic and commercial success.  With respect to Compliance, it’s third-party regulator and NGO requirements and expectations that are in place to ensure a baseline-level of performance, for quality – whether the company wants to or not.   My long experience has been that those organizations that do the best jobs with defining quality requirements and expectations – and driving relentlessly to meeting them consistently – are the same organizations that achieve the best outcomes with compliance.

In my opinion, the focus for FDA-regulated industry shouldn’t be on devaluing one discipline versus the other.  On the contrary, the focus should be on doing rigorous definition of the requirements and expectations for both Quality and Compliance;  aligning these efforts where commonality of approach exists; and ensuring sufficient systems, practices, and people exist to consistently carry out the activities that achieve both sets of requirements and expectations.

Quality is important.   Compliance is important.  Let’s stop bashing compliance.   Let’s focus on doing both disciplines better.

 

Filed Under: Achieving Compliance

Primary Sidebar

Sign Up To Our Newsletter

You May Also Like

Sue Soderholm to be a Featured Speaker at the 1st Annual Quality Management vSummit – “Optimizing Your Quality Management Program to Be Both World Class and FDA-Compliant” | Tuesday, October 11, 2022 – Wednesday, October 12, 2022

Achieve True Quality Culture and Stay Compliant If your quality management system (QMS) isn’t world class, you may be falling behind. You need the 1st Annual
life sciences staffing

Talk to us about current talent trends, and what the industry will need in the next 5 to 10 years?

Transcript taken from 2022 PMWS by Executive Platforms The talent crisis as it has been called is certainly not something that has gone away or

Preparing for an FDA Pre-Approval Inspection (PAI) – “Begin with the End in Mind.”

Presented by: Teresa Gorecki, Practice Lead, Compliance Architects What is it Steven Covey said in “The 7 Habits of Highly Effective People?” “Begin with the

Footer

Compliance Architects®

  • Contact Us
  • (888) 734-9778
  • info@compliancearchitects.com

Quick Links

  • About Us
    • Senior Staff
    • Why Us
    • Mission And Vision
    • Clients
    • Partners
    • Career Opportunities
  • Services
    • Inspection Readiness & Enforcement
      • FDA Inspection Readiness
      • Audits & Assessments
      • FDA Enforcement Response/Remediation
    • FDA Quality Consulting
      • Quality System & Compliance Turnarounds / Restructuring
      • Training / Coaching
      • Quality & Compliance Computer-Based Systems
      • External Supply Chain Compliance
      • Part 11 & Computer Systems Validation
      • Turnkey Quality Systems
    • Quality Assurance and Engineering
      • CRPN Quality Roadmap®
      • Quality Culture Assessment
      • Product Quality Consulting
      • Operational Efficiency/Compliance Effectiveness
      • Project/Program Management
    • Corporate Compliance and Litigation
      • Corporate Compliance Programs
      • Interactions With Department Of Justice And The Courts
    • FDA Regulatory Consultants
      • Product Development / Submissions / Commercialization
      • REMS (Risk Evaluation And Mitigation Strategies)
      • Mergers / Acquisitions / Licensing
    • Quality, Compliance, Regulatory & Operations’ Staffing
      • Staffing
      • Talent Management
      • Rapid Turnaround
  • Innovative Solutions
    • Writing for Compliance®
    • CRPN Quality Roadmap®
    • Quality Pulse®
    • IEEP
    • REMS
  • Success Stories
  • Industries
    • Biopharmaceuticals
    • Cannabis/CBD
    • Cell & Gene Therapies
    • Combination Products
    • Cosmetics
    • Dietary Supplements
    • Medical Devices and Diagnostics
    • Pharmaceuticals
  • Contact Us

Our Services

  • Inspection Readiness & Enforcement
  • FDA Quality Consulting – Systems and Training
  • Quality Assurance and Engineering
  • Corporate Compliance and Litigation Services
  • FDA Regulatory Consultants – Due Diligence
  • Quality, Compliance, Regulatory & Operations’ Staffing Services

Proprietary Solutions

  • Writing for Compliance®
  • Quality Pulse®
  • CRPN Quality Roadmap®

© 2009-2023 Compliance Architects Holdings LLC – used by permission. All copyrights, trademarks and other intellectual property are the property of Compliance Architects Holdings LLC and are used by permission.

  • Debarment Certification Statement
  • Privacy Policy
  • Terms of Use

Contact Us Today

We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies.
Do not sell my personal information.
Cookie SettingsAccept
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
SAVE & ACCEPT