How to Establish the Frequency of the Quality Audits in 3 Steps?

how to determine the frequency of the Quality Audits

 

In this article, you will learn how to establish the frequency of the quality audits according to the cGMP Good Manufacturing Practices in three (3) single steps.

Many federal regulations and company policies require to comply with specific audit schedules, control of audit tools and features, view completion dates, audit observations or results, and detailed information such as issues that require further investigation, CAPA generation, etc.

Three (3) Steps to Determine the Frequency of the Quality Audits.

The frequency of the quality audits can be established based on one or more of the following considerations:

  1. Company policies and procedures instructions and requirements.
  2. Historical audit results of previous inspections.
  3. Risk analysis of the quality systems incidents and failures.  For example, the number and severity of the complaints, field actions, recalls, CAPA investigations, etc.

Even though most companies perform audits using a pre-established frequency between every three (3) months to every year to different quality systems, other companies establish their own frequency of auditing based on a risk assessment to determine which type of audit shall be done to each area.

Based on this information, a recurrent audit date or frequency can be generated, and certificates of audit completion must be sent and stored in the document control file.

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CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at ramon.cayuela@ciqa.net.

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Quality procedures templates

Three (3) Options to Create Document Control Management DCM Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the Document Control Management DCM procedure templates in .pdf format. 

To see the complete list of the most popular quality procedures templates, click here.

In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill, and adapt to your specific needs.

Silver Option. We Can Bring You Formal Training about the frequency of the Quality Audits.

This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

Gold Option. We Can Create Customized Quality Procedures.

One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.

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REFERENCES: How to establish the frequency of the Quality Audits

STATUTORY AND REGULATORY REQUIREMENTS

TITLE 21–FOOD AND DRUGS

PART 820 Medical Devices

820.22 Quality audit. Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.22

2 CFR § 200.501 – Audit requirements

httpss://www.law.cornell.edu/cfr/text/2/200.501

For more information about the frequency of the Quality Audits, refer to:

httpss://www.intertek.com/auditing/gmp/

httpss://haccpmentor.com/gmp/gmp-audit/

httpss://ispe.org/initiatives/regulatory-resources/gmp/audit-considerations

httpss://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap

httpss://www.fda.gov/media/90179/download

httpss://www.orielstat.com/blog/what-is-mdsap-certification/

httpss://www.bsigroup.com/en-US/medical-devices/Our-services/Medical-Device-Single-Audit-Program/

httpss://www.tuvsud.com/en-us/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-single-audit-program-mdsap 

Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!