In this edition of Devine Guidance, the doctor will explore the need for performing internal audits. The doctor would like to add that the performance of timely audits or in some cases, not performing audits at all is one of the frequent non-conformances cited by Dr. D during the performance of audits for my clients. True story, I visited a supplier earlier in the year that emphatically stated that their organization “really did not have to actually perform audits, just plan for them.” Do you know how difficult it was for the doctor to keep from laughing hysterically? But hey, audits are a learning experience and hopefully the lesson taught by Dr. D was a memorable one.
(Internal Audit)Article 56 The manufacturer, etc. shall conduct the internal audits at planned intervals to determine whether the quality management system meets the following requirements.(1) To conform to the arrangements defined in the product realization plan, to the requirements of this Ministerial Ordinance and to the quality management system requirements established by the manufacturer, etc., and(2) To be effectively implemented and maintained.2. The manufacturer, etc. shall ensure that the audit program is planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of the previous audits.3. The manufacturer, etc. shall ensure that the audit criteria, scope, frequency and methods are defined.4. The manufacturer, etc. shall ensure that the selection of the personnel who conduct the audits (hereinafter referred to as “auditors”) and the conduct of the audits ensures objectivity and impartiality of the audit process.5. The manufacturer, etc. shall ensure that the auditors do not audit their own work.6. The manufacturer, etc. shall ensure that the responsibilities and requirements for planning and conducting the audits, and for reporting the results and maintaining the records are defined in the documented procedure.7. The manufacturer, etc. shall ensure that the management responsible for the area being audited ensures that the actions are taken without undue delay to eliminate the detected nonconformities and their causes and the follow-up activities include the verification of the actions taken and the reporting of the verification results.
- Be documented by an established procedure;
- Ensure audits, assessing all aspects of the QMS, are performed;
- Define audit frequency;
- Define the publishing of an audit schedule;
- Define audit scope and methods employed for auditing;
- Contain requirements and skills for auditors (recommend reading ISO 19011);
- Contain a requirement that auditors cannot audit their own work or functional organization;
- Ensure audit results, including non-conformances noted, are recorded and retained as a quality record;
- Ensure re-audits and increased frequency of audits are performed for problem areas; and
- Ensure that corrective action is pursued when non-conformances are identified during the execution of an internal audit.
Another point Dr. D would like to make is that if your organization decides to use an external auditor, make sure the auditor trains to your Internal Audit SOP and evidence of this training is documented.
|Table 1.0 – Sample Requirements Matrix
||Procedure Name||Requirement||21 CFR, Part 820||EN ISO 13485:2003||MHLW MO 169|
|1266-1 Rev B||Internal Quality Audits||Internal Audit||820.22||8.2.2||
- Use the internal audit program to gage the effectiveness of the QMS and to drive continuous improvements.
- Performing internal audits is not optional. Internal audits are mandated by MO 169.
- Make sure internal auditors are adequately trained (reference ISO 19011).
- If your organization does not have the resources available to perform internal audits, it is an acceptable practice to hire a 2nd Party Auditor (give Dr. D a Call).
- Code of Federal Regulation. (2011, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- EN ISO 13485:2012. (2012, February). Medical devices – quality management systems – requirements for regulatory purposes (EN ISO 13485:2012).
- Linguanaut the Japanese phrases and expressions. (2012). Retrieved September 8, 2012, from http://www.linguanaut.com/english_japanese.htm
- Ministerial Ordinance 169. (2004). MHLW ministerial ordinance 169 on standards for manufacturing control and quality control for medical devices and in-vitro diagnostic reagents. Retrieved June 1, 2012, from http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf