Risky Business: Developing Your Internal Audit
Risky Business: Developing Your Internal Audit
Auditing is a key component in the measurement of the effectiveness and performance of a quality system. It can be performed by employees of the lab or by an outside auditing firm. A quality audit is a formal, planned check of all elements of the quality system. FDA states in its inspection guidelines that, “without an effective quality audit function the quality system is incomplete and there is no assurance the manufacturer is consistently in a state-of-control”.
Both FDA and DAMAS require, at a minimum, an annual audit. DAMAS requires that the lab audit the management system to verify that the manufacturing processes comply with planned arrangements.
FDA states in Section 820.22 of the Quality System Regulation that you establish procedures for quality audits and conduct the audits to assure that your system not only complies with quality system requirements, but that the audit determine the effectiveness of the quality system.
An internal audit is a process of comparing actual operations against the commitments that the lab has made in its quality system. There must be a written schedule of quality audits. The time between quality audits should not exceed a 12-month period. More frequent audits may be conducted if the results of the audits indicate serious Quality System Regulation problems.
Individuals conducting the audit must be appropriately trained. Audits should be conducted by individuals not having direct responsibility for matters being audited. For a smaller lab, it may mean hiring an independent outside auditor. FDA can cite for a lack of adequate audits if in their inspection they identify serious deficiencies.
Re-audits either by your internal auditor or an external auditor may be required for serious deficiencies.
FDA is prohibited from reviewing results of quality audits. They can ask for the management representative to confirm that audits have been conducted. It is to be noted, however, that if an audit results in the need for corrective action that the corrective action records are viewable by FDA.
So, where do you begin to prepare your audit and audit schedule. One method in setting your schedule is to select components of your written quality system and divide them into four different audits. For instance, your audits could be divided as follows:
- Document Control
- Materials
- Training, Equipment and Facility Maintenance
- Customer Satisfaction – remakes, complaints, CAPA
Effective audits must be properly planned and executed. Developing an audit checklist will ensure that audit planning is conducted and that the auditor knows what questions to ask. A well-designed audit checklist significantly improves the process awareness, audit structure and documentation.
Your audit checklist for the above components could include the following:
Document Control
- Procedures to control all quality documents.
- Designation of someone to review all documents prior to issue.
- Formal procedure to change quality documents.
- Retention of copies of FDA’s Quality System Regulation, DAMAS Specifications if DAMAS certification has been obtained, and any state regulations that may apply.
- Issuance number or date on each quality document.
- Changes to the quality documents since the last audit.
Materials
- Procedure for evaluating new suppliers, subcontractors and consultants.
- Current evaluations for suppliers, subcontractors, etc.
- Procedure for purchase of materials including initial ordering to verification of items received.
- Documentation of the receipt process.
- Verification of expiration dates of products upon receipt and in production areas where they’re being used.
- Traceability of patient contact materials through batch numbers and lot numbers.
- Complaint against vendors and subcontractors, review process and corrective action taken.
Training, Equipment and Facility Maintenance
- Documentation of competencies and/or skill levels of workers.
- System for identifying training needs.
- Documentation of training.
- Availability of operating instructions for equipment.
- Maintenance and repair schedules for equipment.
- Cleaning schedules for facility maintenance and cleanliness.
Customer Satisfaction – Remakes, Complaints, CAPA
- Procedures to determine if product conforms to your internal specified requirements and the requirements of the customer.
- Procedure for documenting and tracking corrective actions taken on remakes and complaints.
- Investigation and determination of root cause for remakes.
- Formal review of above information.
This is in no way intended to be a complete audit checklist. Take this information and develop a thorough audit checklist so you have a primary tool that will bring order to your quality audits. With a well-planned and well-defined checklist, a successful audit is achievable. Remember the first step in auditing is to completely understand the governing requirements such as the FDA Quality System Regulation and DAMAS Specifications.
After your audit, your final step is to write-up your audit report in order to communicate the results of the investigation. Provide correct and clear data that will be effective as a management aid in addressing important organizational issues. The audit ends with presentation of this report, however, follow-up and closure actions may be necessary.
