Week 2 – Areas to Audit

Welcome to Week 2 of our 52 Weeks to RA/QA Clarity!  The first 4 weeks are devoted to Internal Quality Audits, with last week’s discussion focusing on the audit schedule.  This week we shift to what areas to audit as part of the schedule.

The standards do not provide guidance, but only generically state (FDA 21CFR820.22):

“Assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system.”

Many companies are unclear as to how the FDA expects this requirement to be met.  Once your scheduling is planned (and documented), the next step is to figure out what sections to group together.   People are always surprised when I tell them that grouping is not dependent upon the schedule.  You can perform audits on a weekly basis or on a annual basis.  The grouping should follow a simple pattern.

Audit patterns are determined on two inputs:

  1. Government Auditors are trained to follow the product through the system.
  2. The flow of product from raw material receipt through final product delivery to customer.

Both of these follow the same pattern.  This is because it ensures that all areas of the company and product are audited.  Each company (and product for that matter) will have unique steps in the process.  The bonus for using this pattern is that it can be applied to any company and any product and any process:

  • Supplier Audits
  • Outsourced Activity Audits
  • Internal Quality Audits

Lets get down to work!  The goal is to make the audit process as simple as possible.  Here is the pattern:

  1. Quality Manual
  2. Suppliers
  3. Raw materials
  4. Manufacturing
  5. Nonconforming Product
  6. Organizational Chart
  7. Employee records
  8. Design Master File
  9. Device Master Record
  10. Packaging
  11. Labeling
  12. Sterilization
  13. Shipping
  14. Distribution Records
  15. Communications with customers
  16. Complaints
  17. CAPA
  18. Communications with Regulatory Bodies

While going through the pattern, view the base procedures, work instructions and forms.  Then that will inform you on what documentation to expect within the system.

Now, time for more detail!

Quality Manual

The purpose of the Quality Manual is to verify that the top management ensures that an adequate and effective quality management system has been established and maintained.


A supplier is a supplier delivering materials, components, or services that may influence the safety and performance of the product.

The purpose of auditing the purchasing control subsystem is to verify that the manufacturer’s processes ensure that products, components, materials and services provided by suppliers, (including contractors and consultants) are in conformity.

Raw materials

The purpose of auditing the raw materials delivered from the supplier is to ensure that products ordered are the exact ones delivered.


The purpose of auditing the production and process control subsystem (including testing, infrastructure, facilities and equipment) is to verify that the manufacturer’s production and process controls are able to ensure that products will meet specifications.

Nonconforming Product

Verify that controls are in place to prevent distribution of nonconforming products.


The purpose of auditing Quality Management System activities associated with the development, procurement and/or use of software is to ensure the software meets its user needs, intended uses and specified requirements.

Note: Software includes: (1) software embedded within a medical device; (2) software that is a stand-alone medical device; (3) software used to control quality management system processes.

Organizational Chart

Review the manufacturer’s organizational structure and related documents to verify that they include provisions for responsibilities, authorities (e.g., management representative), resources, competencies and training.

Management Review

Verify that management reviews are being conducted and that they include a review of the suitability and effectiveness of the quality management system.

Employee records

The purpose of auditing employee records is to ensure an appropriate background of experience and training for the associated job description.

Design Master File

The purpose of auditing the design and development subsystem is to verify that the design and development process is controlled to ensure that medical devices meet user needs, intended uses and specified requirements.

Device Master Record

The purpose of auditing the Product Documentation Subsystem is to verify that the manufacturer’s documentation ensures that products meet customer and regulatory requirements.


The purpose of auditing the sterilization process (including testing, infrastructure, facilities and equipment) is to verify that the processes are appropriate to produce sterile products.

Distribution Records

The purpose of auditing distribution records is to ensure that product ordered by customers was delivered.  Also to ensure that product delivered meets regulatory requirements.

Communications with Customers

The purpose of auditing customer related processes subsystem is to verify that customer related processes ensure that requirements including regulatory requirements are addressed by the quality management system.


Confirm that customer feedback is analyzed in the product realization process and used to re-evaluate the risk assessment and, where necessary, adjust the risk management activities.


The purpose of auditing the CAPA subsystem (including reporting/tracking) is to verify that manufacturer’s processes ensure that information is collected and analyzed to identify actual and potential product and quality problems, and that these are investigated, and appropriate and effective corrective and preventive actions are taken.

Communications with Regulatory Bodies

Verify that medical device reporting is done according to the applicable regulatory requirements.

By following the flow of product, from raw material receipt through final product delivery to customer, the auditor ensures all aspects of the system have been viewed.  This ensures the system meets regulatory requirements as well as determining the effectiveness of the system.

As an added bonus this week, we have included a copy of our INTERNAL AUDIT CHECKLIST.

Please feel free to ask us any questions in our Facebook group slot machine arm.  We look forward to continuing the conversation!