An audit is a tool for systematic, independent and documented monitoring verification of an organization’s quality policies. It serves to verify the conformity of ongoing laboratory practices to regulatory guidelines.
Audits contribute to the growth and rising profitability of laboratories through streamlining of operations. Documentation and recording of laboratory activities is the secret of successful audits.
Audits mainly fall into two main categories:
- Internal audits
- External party audits
Internal audits are periodic exercises conducted by the organization aimed at evaluation of laboratory operations using internal resources for review of efficiency, safety, and adherence to quality management systems whereas the objectives of audits by external parties are different. These are mainly concerned with recognition or accreditation by a regulatory body such as ISO, NABL, etc or evaluation of fitness by a customer or his deputed agent on the capabilities of the laboratory to provide reliable testing of its products.
Internal Audit Plan
An internal audit should comply with an action plan comprising:
- Appointment of a team leader who decides the auditing team
- Definition of audit objectives, scope, and criteria
- Delivery of scope of the audit to auditees in advance
- Review of documents and records
On-site activities include
- Opening meeting and communication with auditiees
- Inspection of concerned departments
- Preparation of audit report
- Post audit follow-up including a time frame for completion of a corrective and preventive action plan
- The quality manager decides re-audit if required
- Internal audit record should be preserved for a minimum of five years after the audit date
Typical Non-conformances in laboratories
- Continued use of unrevised SOP’s
- Failure to adapt and follow SOP guidelines
- Unauthorized changes to SOP’s and STP’s
- Presence of obsolete documents in folders
- Non-maintenance of calibration schedules or use of un calibrated instruments
- Use of expired working standards
- Non-maintenance of calibration records
- Non-maintenance of instrument use logbooks
- Chemists not provided required training for the tasks performed by them
- Non-operational safety devices such as fire extinguishers safety showers, etc
- Non-maintenance of sample receipt and disposal records
- Disposal of laboratory waste and in particular biological waste in non-conformance with existing guidelines
- Non-maintenance of servicing and maintenance records of instruments
In most organizations, internal audits are taken lightly whereas external audits are dreaded. Before the audit date, you will find chemists frantically updating their records and quality assurance persons scurrying around like rabbits ensuring that everything is in order before the audit date. Strictly speaking, this activity and haste prove counter-productive as in the ensuing haste several loopholes remain unplugged. Further, the practice of putting the house in order before the external audit is also not in compliance with GLP practices. This is exactly why internal audits help provide the morale boost to the management and staff of laboratories.
It has been rightly said that:
“The more you sweat in peace (internal audits), the less blood you will shed in war (external audits)”
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