Science & Research

Volume II - Audits ORA-LAB.4.14

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Food and Drug Administration



Audits ORA-LAB.4.14



Sections Included in this Document and Change History

(Document No. changed from 4.13 to 4.14)

  1. Purpose
  2. Scope
  3. Responsibilities
  4. Background
  5. References
  6. Procedure

    (6.1 – flowchart form graphic name changed to NC_CA; 6.2 K. – renamed corrective action form to NC_CA;
    6.2 L. – revised; 6.3 A. – changed “quarterly” to [frequency]; 6.3 C. – rename form to NC-CA)

  7. Definitions
  8. Records/(deleted Audit Resolution Report; renamed Corrective Action Reports)
  9. Supporting Documents/(added ORA-QMS.007 & ORA-QMS.004)
  10. Attachments/(Attachment A – added to title “Example”; deleted Attachment C)
  11. Document History

1. Purpose

The [Name (i.e. District Office or Laboratory)] conducts systematic internal audits to monitor and determine compliance with the requirements of the quality system and standards. The [Name (i.e. Laboratory Branches)] perform [Time Interval (e.g. quarterly] performance audits to evaluate the technical activities of employees and product produced by those employees. The quality system needs to evolve or continually improve to fulfill its purpose. This procedure establishes the method by which internal audits and performance audits are performed within the [Name].

2. Scope

This procedure applies to [Name] activities that directly affect the quality of work products.

Internal quality system audits are performed on a predetermined schedule and as otherwise directed by management. Performance audits are performed [Time Interval (e.g. quarterly)] by the [Name (i.e. Laboratory Branches)]. Summary reports of audits are maintained by the Quality Management System Manager.

3. Responsibilities

  1. [Third Level Manager]:
    • ensures information and access is provided to auditors, and
    • completes corrective action.
  2. [Second Level Manager]:
    • informs staff of audit schedule and
    • ensures corrective action is taken on findings and follow-up actions.
  3. [First Level Manager]:
    • establishes and maintains organizational, operational and quality policies; and
    • provides for the personnel and resources to ensure that activities used are capable of meeting the needs of the customers.
  4. Quality System Manager (QSM):
    • provides any forms or checklists,
    • acts or designates lead auditor,
    • coordinates the audit and ensures that auditors have the correct training and guidance for their work,
    • monitors audit activities, assembles summary report and initiates corrective action,
    • monitors timely resolution of audit findings,
    • maintains summary reports, and
    • coordinates regional performance audits
  5. Auditor:
    • reviews background documentation,
    • performs audit in accordance with audit schedule and checklist, and
    • collects objective evidence to support findings.

4. Background


5. References

  1. EAL-G3, Internal Audits and Management Review for Laboratories
  2. ISO 19011:2002, Guidelines for Quality and/or Environmental Management Systems Auditing.

6. Procedure

  1. The internal audit process is illustrated in the flowchart.

6.1 Internal Audits Flowchart

Flowchart showing the internal audit process from selection of auditors to final report as outlined in Section 6.2 of this document

6.2 Internal Audit Process

  1. Internal system audits are planned and scheduled by the Quality System Manager. The review activity and ISO 17025 internal audit schedules are defined in Attachment A.
  2. The areas to be audited will be detailed out in this schedule. These areas include:
    • ISO requirements checklist review;
    • methods and procedures;
    • review procedures;
    • staff and record keeping of training;
    • equipment and functional verification and preventive maintenance charts;
    • proficiency surveys;
    • quality control (QC) and QC charts;
    • workload, sample and data handling processes;
    • records and reports (work products);
    • standards, organisms, certified reference materials;
    • housekeeping;
    • chemical storage;
    • hazardous waste; and
    • laboratory environment.
  3. Audits will be carried out by personnel who are independent of the area they are examining. Personnel conducting audits are trained and qualified based upon completion of one or more of the following criteria:
    • previous demonstration of performing audits (e.g. FDA inspections, ORA audits);
    • documented training conducted by laboratory QSM; and
    • successful completion of a recognized auditing course.
  4. The QSM may direct examinations of single aspects of the Quality Management System (e.g. laboratory reports).
  5. Checklists to be used and previous audits reports, corrective actions and audit checklists are provided to the auditors by the QSM to the designated lead auditor for distribution and review.
  6. If an audit team or external auditor is utilized, the team or auditor will on the day of audit begin by conducting an opening meeting with the [Name] and [Name] responsible for the functional areas and sections to be audited. During this meeting, the lead auditor will introduce the audit team, outline the plan of action and obtain the names of the section personnel who should be contacted to assist the auditors in each functional area. This meeting can be conducted by various means, i.e. physically or electronically.
  7. Auditors conduct the audit in accordance with the schedule and document audit findings. Auditors receive information through several sources:
    • interviews with personnel,
    • examination of documentation,
    • observation of activities and conditions,
    • review of quality and technical records, and
    • use of checklists.
  8. In order to assess all areas of the audit, auditors may select a violative case and follow its progress from beginning to end examining all aspects of the quality system relating to it.
  9. Upon completion of the audit, the lead auditor will compile the findings and provide the section representatives with a preliminary report. This preliminary report is a synopsis of the findings and provides section personnel with an opportunity to voice any objections. If valid objections are raised, the audit team should adjust their findings accordingly.
  10. The QSM assimilates all data from the audit and prepares an audit summary report. The audit report, corrective actions and follow-up activities are discussed [Frequency (e.g. weekly)] during management meetings.
  11. A NonConformance Corrective Action (NC_CA) form is initiated for audit findings by the QSM for the Branch Directors or designee to complete. The QSM will track and monitor the progress of corrections, provide assistance and direction as needed. Corrective action is undertaken by the responsible [Name] and [Name] and resolutions submitted to the QSM within 30 days.
  12. The NC_CA form includes the resolutions of the corrective actions taken and follow-up activities is prepared by the QSM through the [Name] to the [Name] and staff.
  13. In the event, the audit identifies a problem associated with incorrect procedures, invalid action or invalid data, immediate corrective action will be taken. The QSM will notify the [Name] to determine the most efficient method of notifying the client (i.e. by telephone, email, fax or letter). This notification will be documented. Corrected reports will be issued.

6.3 Performance Audits

  1. Performance audits are performed [frequency] by each [Name ( i.e. Laboratory Branch)] and coordinated by the QSM. Corrective action is performed on noted discrepancies. Performance audits are included as part of the internal audit.
  2. Completed review forms are returned to the [Name] for review.
  3. Forms and memorandums are submitted to the QSM for review and filing. A NC_CA form is initiated for discrepancies noted by the QSM for the Branch Director or designee to complete. Corrective action is undertaken and resolutions submitted to the QSM within 30 days.
  4. A [Time Interval (e.g. bi-annual)] summary report is submitted to the regional office by the QSM through the [Name].
  5. Performance Audits
    1. Worksheet Review
      1. An Analyst Worksheet Quality Assurance (QA) Review form is completed by the [Name] for at least [Number] of Class 3 worksheets [Time Interval (e.g. quarterly].
      2. An Analyst Worksheet QA Review form is completed by the [Name] for at least [Number] Class 1 and Class 2 worksheets [Time Interval (e.g. quarterly)].
      3. An Analyst Worksheet QA Review form is completed by the Supervisor at the rate of one worksheet for each analyst [Time Interval (e.g. quarterly)].
      4. Field Accomplishment and Compliance Tracking System (FACTS) information is checked for accuracy, completeness and agreement with hardcopy worksheet.
      5. On-the-spot corrective action is annotated on the form.
    2. Sample Accountability Review
      1. A Sample Accountability QA Review form is completed for [Number] assigned samples, [Number] unassigned samples and [Number] closed samples.
      2. FACTS information is checked for accuracy and completeness.
      3. On-the-spot corrective action is annotated on the form.
    3. Oral Review (Optional)
      1. The QSM schedules through the Compliance Branch Director depending on workload and availability of compliance officers [Number] oral reviews quarterly. The goal is to conduct an oral review for each analyst and technician within four years.
      2. An Oral Review form, selected analyst worksheets and applicable procedures and programs are distributed to personnel in advance.
      3. The analyst or technician verbally answers the questions to the Compliance Officer (CO) with their Supervisor in attendance.
      4. The CO evaluates the responses and completes the Oral Review form and returns documentation to the [Name].
      5. On-the-spot corrective action is annotated on the form.
    4. On-Site Review
      1. An On-Site Review form is completed for each analyst or technician on an established schedule.
      2. On-the-spot corrective action is annotated on the form.
    5. Laboratory Controls QA Review
      1. A Laboratory Controls QA Review form is completed.

7. Definitions

Audit – An audit is a planned and documented investigative evaluation of an item or process to determine the adequacy of and compliance with planned arrangements and whether these arrangements are implemented effectively and are doable to achieve objectives.

Audit summary report – An Audit Summary Report is a summary of the audit scope and findings, as illustrated by Attachment A.

Corrective action request (CAR) – A Corrective Action Report is a request to initiate corrective action.

Fitness-for-use criteria – These criteria are quality elements needed for purposeful work. Work requests or compliance programs directing a piece of work or general guidance documents, such as the Laboratory Manual, the Quality Management System Manual, pertinent laboratory procedures and work instructions, contain quality elements.

Monitor – To monitor is to observe and record activity to measure compliance with a standard of performance, routine and ongoing collection of data about the indicator.

Non-conformity – A non-conformity is non-fulfillment of a specified or implied requirement of the quality management system or of a quality work product.

Objective evidence – Objective evidence is information, which can be proven true, based on facts obtained through observation, measurement, test, or other means.

Observation – An observation is objective evidence that creates concern that may indicate future problems.

On-the-spot corrective action - This is an immediate step taken to correct or resolve a non-conformity.

Performance audit – a performance audit is an assessment of the technical activities of personnel and are categorized as a quantitative appraisal of quality.

Requirement – A requirement is a declared, implied or routine need or expectation.

System audit – A system audit is an on-site assessment of the laboratory’s quality management system and referred to as a qualitative appraisal of quality.

8. Records

Audit Summary Report
Non Conformance Corrective Action Reports
Performance Review forms

9. Supporting Documents

[Name]-Corrective Action Procedure

ORA-QMS.007, Corrective Action Procedure

ORA-QMS.004, Audits

10. Attachments

Attachment A: Examples of Audit Schedules (PDF PDF Document, 50 kb)

Attachment B: Audit Summary Report Example (PDF PDF Document, 18 kb)

11. Document History

Version No. Status
(I, R, C)
Date Approved Location of Change History Name & Title
Author Approving Official
1.4 R 12/31/07 In Document LMEB LMEB
1.5 R 02/06/12 In Document LMEB LMEB

Approving Official’s signature: _________________________________ Date: _____________

Page Last Updated: 03/18/2016
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