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Process Auditing Approach-Documentation Requirements
We will begin our discussion of how to perform successful process audits with documentation requirements. Audit documentation is an essential component to any internal or external audit. In simple terms, audit documentation refers to the record of the performed audit, relevant evidence obtained during the audit and conclusions drawn from the audit. While documentation independently isn't sufficient to determine the quality of an audit, it provides the groundwork necessary for a quality audit to result.
Audit Documentation serves a number of purposes, including:
Assistance to the team during the audit itselfProviding summaries for new audit team members, bringing individuals up to speed more efficientlyDemonstrating the audit team's accountability for the information gathered and sharedRecord keepingProviding a method of succession to future auditors and auditing teamsSome key considera tions within the realm of documentation requirements include the organization's Quality Manual, control of documents, and control of records.
Quality Manual
What should you look for with respect to the Quality Manual? Objective evidence examples can include the scope of the Quality Manual in relationship to the certification scope, any exclusions that are deemed justifiable and the Quality Manual including procedural references. In addition to the collected documents, consider asking about any processes described or mentioned in the Quality Manual. And, inquire as to whether the process interactions are described, and if so, in what specific manners.
Control of Documents
When examining control documents, consider looking for a clear outline of key employee responsibilities, particular in the areas of development, approval and distribution. In addition, examine the procedures, instructions, manufacturing/maintenance fi les, and purchasing contracts. And if the organization utilizes electronic formats for documentation validation, be sure to examine. As you examine each of these areas, consider inquiring into how external documents are controlled as well as into the organization's documentation retention requirements.
Control of Records
When considering the control of records, be sure to look for how records are identified and controlled, what retention times are being utilized, record storage responsibilities, accuracy of records and the record destruction processes being utilized. During the control of records portion of your audit, be sure to ask whether the organization utilizes paper or electronic methods, the specific lengths of time records are maintained, who documents record retention, how records are communicated with suppliers and for specific examples of how records are retrieved.
Preparing what to ask and what to look for when auditing an orga nization's documentation requirements, will enable you to work more efficiently and accurately during your physical audits. These tips and more are often covered in AS9100 lead auditor training, something worth investing in to improve your audit's overall accuracy.
Understanding how AS9100 Lead Auditor Training can benefit you and your company is paramount to success in today's global market. AS9100 Auditor Training can be effectively employed cost-effectively to give you and your business the edge. Visit our website to learn more, and thanks for reading.