Internal audits

System Safety Engineering and Risk Assessment A Practical Approach 

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The GMP details certain requirements for the quahty system, such as the independence and responsibihties of the quahty control unit. It requires such activities as internal audit to monitor GMP conformance, employee training, complaint investigation, failure analysis, and verification of proper manufacture and test by QC prior to release of the batch. 

Part of the evidence required is the result of at least one complete internal audit and management review cycle. 

Each on-site audit, including initial and surveillance audits, shall include a review of supplier internal audit and management review results and actions and progress made toward continuous improvement targets. 

The auditor should verify that all elements have been subject to internal audit during the initial audit and, if not, a nonconformity is warranted. 

During the initial audit evidence of progress on audit and review actions, and progress toward Cl targets has to be demonstrated. Hence it is not sufficient for the supplier to have defined Cl targets, and not sufficient for internal audits and management reviews to have been conducted - there has to be evidence of achievement. 

You will need to provide evidence of internal audits and management review from the previous 12 months with your application for certification. 

Do the internal audits verify whether quality activities and related results comply with planned arrangements ... 

There are three references to the management review in other sections of the standard preventive action information (clause 4.14.3), internal audit results (clause 4.17.1), and changes to procedures (clause 4.14.1.1) are required to be submitted for management... 

Your corrective action procedures need to cover the collection and analysis of product nonconformity reports and the collection and analysis of process data to reveal process nonconformities. The corrective action provisions of your internal audit procedure need to address the causes of the nonconformities and you will need an additional procedure to deal with external audits, investigating the cause of any nonconformities and recording the results. The procedure also needs to cover the investigation of customer complaints as the previous requirement only deals with the handling of complaints. 

The requirements for internal audits apply to audits of the quality system, including the policies, practices, products, and services to which the quality system relates. They are not limited to audits of procedures. In order to determine whether the quality system is effective in maintaining control, you need to check that the resultant products and services meet the specified requirements and that prescribed quality objectives are being achieved. If the products and services are not meeting the specified requirements, or the prescribed objectives are not being achieved, something is clearly amiss with the quality system. The requirements do not apply to audits of suppliers or subcontractors as they are covered in clause 4.6 of the standard. 

The system audit process is shown in Figure 17.2. Certain activities such as the opening and closing meeting have been omitted for clarity because they are not always needed for internal audits. The product audit process would be somewhat different but the principles would be the same. Further guidance on the conduct of audits can be found in Appendix C. 

The related results are the results produced by implementing the policies and procedures. They include documents, decisions, products, and services. It is not enough for internal audits to verify that procedures are being followed. They need to verify whether the outputs of these procedures comply with the prescribed requirements. 

Audits of a company or parts thereof by personnel employed by the company. These audits are also called internal audits. 

All parts of the quality (ESH/PSM) system should be reviewed and evaluated on a regular basis via internal audits. This section of the standard... 

Large and complex projects will be monitored as the expenditure proceeds while smaller outlays will be looked at after completion. The purpose of such monitoring is to provide a comparison of actual expenditure with that estimated when the project was sanctioned. The accounting or internal audit departments will normally carry this out. However, for a sensible comparison to be achieved it is essential that the planned expenditure demonstrated in the project be classified in the same way that the actual expenditure will be analyzed. While somewhat obvious, this is an area where very great difficulty is often met in practice, especially where large projects are involved. 

Be certain that spill hazards are reviewed as part of the plant s internal audit program. Audit-team members should be trained to look for deficient containers, fall hazards that also can contribute to a spill, improper container labeling, and other potential hazards. Major causes of chemical spills are ... 

The regular internal auditing of a quality system is a fundamental requirement. These audits should be conducted by persoimel independent of the operational area being audited for example a quality department should not audit its own activities. The results of such audits, together with those from outside inspection bodies, will invariably identify areas for improvement. 

Monitoring and Measurement (customer feedback, internal audits, process monitoring, finished product release)... 

Self-inspection - regular internal auditing and follow up corrective actions... 

Regular internal audits of GMP operations should be conducted according to an audit master schedule. Records of the findings and any follow-up actions should be maintained. Audits of key suppliers should also be conducted as part of a vendor qualification programme. 

Monitoring and measurement - Establish customer complaints/feedback and internal audits processes, evaluate effectiveness of processes, verify product meets acceptance criteria... 

Over the past decade, a major trend has been the development of the use of proficiency testing (PT) or evaluation materials (Fox 2000). PT materials are a type of reference material, which aid in assessment of analytical laboratory measurement quality. There will be an increased use of such materials as part of laboratory accreditation programs and other new quality assurance efforts, including internal audits. At the same time, a number of providers have used PT schemes to produce a form of RM intended to meet the ever-growing need for RMs required for routine QC use (Jenks 1995,1997). 

Is there an internal audit program How is follow up tracked ... 

Changes take place in the laboratory system to take into account customer feedback and/or laboratory and office feedback. This could be after the completion of the work or as a result of the internal audit. Management review will evaluate the whole system and provide resource to enable changes to take place, e.g. 

You may have already experienced an audit so would be able to identify an internal audit. This is an inspection carried out by staff of the laboratory but who are independent of the work activity carried out in the area being audited, i.e. the auditee. Both the second-party and... 

Quality Audit is the only option available to them. It is therefore vital that, to ensure standards of quality are maintained, a laboratory must operate its own internal audits to test its quality management system. If the internal system of audits is not operating adequately, external assessment visits are liable to be traumatic experiences, awaited with trepidation and producing unexpected and embarrassing nonconformities in several areas of operation. 

The major category of nonconforming work is allocated for any failure of a system to comply with the requirements of the Standard which could lead to invalidity of test results. Examples include absence/non-implementation of a document control system, absence/non-implementation of a procedure for internal audit or management review, staff not technically competent to perform particular tests and failure to control the quality of test data. 

Internal audit Audits conducted by the organization itself for management review purposes - also called first-party audits. 

Responsibihties for Production Activities Internal Audits (Self Inspection)... 

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