Product-specific documents audit

Compliance members, with the help of analytical members of the preapproval audit inspection team, audit the following product-specific documents ... 

Acceptance Criteria/Rationale. The acceptance criteria for each measurable attribute (which can be lifted from the specification document) is important and should always be shared. Likewise, it is recommended that a rationale be provided for each criteria. For example, why must the final product moisture content be 70-80% What if it is 83% The reasoning is that it is better to consider this question before being asked by FDA during an audit, thereby avoiding a situation in which the answer provided may not be the best. 

The hazard log is a live document which, throughout the life of the product provides an auditable record of the management of hazards for the specific system/facility/ operation/activity. It should be a database which contains information to show how safety issues are being dealt with and resolved. The big advantage of the hazard log is that all risks can be compared, prioritised, and (via the Pareto Principle ) the operator can prioritise the hazard management effort on the most likely causes of an accident. 

The general purpose of an audit may be to determine if the toller has management systems and documented procedures in place to ensure process safety, environmental responsibility, product quality and traceability of materials. The need to audit could be to evaluate compliance with regulations or accordance with client requirements related to specific performance elements. A subjective rating system for ranking management systems audit results is often used. An example of one that might be appropriate is shown below ... 

These lists tell us something about the nature of quality records, especially by what is not included. Absent from the lists are policies, procedures, instructions, plans, specifications, and any other prescriptive documents. The records all have one thing in common they describe the results of some activity - the results of inspections, tests, reviews, audits, assessments, calculations, etc. However, these lists are dominated by records relating to product quality rather than to the operations of the quality system. In addition to audit records, the following records may need to be maintained to demonstrate the effectiveness of the quality system ... 

Current quality system models call for audits to be conducted at planned intervals to evaluate effective implementation and maintenance of the quality system and to determine if processes and products meet established parameters and specifications. International standards provide guidance on auditing [13]. Audit procedures should be developed and documented to ensure that the planned audit schedule takes into account the relative risks of the various quality system activities. Factors that can be incorporated into a risk-based approach to planning audit frequency and scope include the following [6] ... 

To maintain control of the computer system throughout its conception, implementation, and operational use in a GMP environment, it is required that the computer system application must be validated in a way that will establish auditable documented evidence that the computer system does what it is expected to do. As applicable, this needs to be carried out in conjunction with plant equipment to provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. The methodology to achieve this is based on a recognized life-cycle mode. 

During each software or system development step, the developer provides documented evidence that implementing the requirements specified in the requirements specification deliverable developed the product. During the design, the in-process (internal) audit must be carried out in order to verify that the design of the computer system satisfies the requirements described in the computer system specification deliverable, and that the code has been developed in accordance with the technical design specification deliverable. 

The batch record is the only documentation a firm has that can demonstrate that the product was manufactured according to specifications. During regulatory audits, the batch record is a primary document for review, and must be easily and quickly accessible. Most firms have two different modes of storage—recently executed batch record storage and long-term archival. It is recommended that a schedule be established to require that the most recent batch records executed (e.g., the last 6 or 12 months) are readily accessible and any batch records older than this be transferred to a long-term archival location. 

The firm failed to document how each specific supplier is evaluated in order to assure their products meet specified requirements as required by their Vendor/Supplier Qualification SOP. Additionally, the firm failed to complete adequate purchasing controls in that they fail to ensure that the initial audit of suppliers is conducted prior to the supplier s acceptance, firm fails to assure components meet specifications (physical specifications), and fails to document in-process rejects. 

In many circumstances, the supplied system will be based on a standard COTS product and include additional features that are superfluous in the intended context. These features cannot normally be disabled because they are integral to the COTS product. Such redundant features should be included in the Functional Specification, noted as superfluous and, if possible, rendered inaccessible to users within the implemented computer system. Standard features that support compliance, such as audit trails for electronic records, should be used even if not defined within the URS. In such circumstances it may be necessary to make additional design allowances for the inclusion of these features (e.g., for audit trail functionality, extra storage capacity may be required). Standard documentation for COTS products can be referenced by the Fnnctional Specification, if available for inspection, rather than reproduced. Care must be taken to refer to the correct version of COTS documentation and to keep cross-references up to date following any system upgrades. 

In the specific implementation of a safety audit project, safety audit project leader should be fully aware of the following circumstances, an initid assessment of the importance of this safety audit and audit risk (1) ask the audited entity related personnel and related management (2) access to the audited entity s operations manual, the internal control manual and other information (3) access to the audited entity annual production and safety plans, financial budget and other documents (4) check the safety activities or safety issues certificates and records (5) examine the audited unit production, business activities and the implementation of internal control (6) select the number of safety events to be tested. 

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