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Questions and Answers
Who is responsible for distributing the audit plan within the organization to be audited?
The lead auditor should notify the client of the impending audit. Is this statement true or false?
True
What are some examples of special needs or plans that the lead auditor should confirm have been arranged?
Travel requirements, communication devices, equipment, security clearances
What are some items that should be included in the logistical plan for an audit?
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What is the primary purpose of an audit checklist?
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Sampling is a technique used to gain information at a reduced cost compared to _______ inspection.
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The purpose of working papers in an audit is to limit the scope of audit activities.
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What is typically included in an audit plan?
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What does ISO 19011, clause 6.3.2.2 specify for audit planning?
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The scope of an audit establishes the boundaries by identifying the exact items, groups, and activities to be __________.
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Lead auditors should maintain communication with the auditee throughout an audit.
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Match the following audit-related documents with their types:
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Study Notes
Audit Preparation and Planning
- An audit plan identifies:
- The purpose (objectives) and scope (boundaries) of the audit
- The auditee and the organizational units to be audited
- The audit team members
- The criteria being audited against (e.g. standards, contracts, or procedures)
- Logistical information (e.g. audit date, location, duration, interview schedule, and meetings with auditee)
- ISO 19011, clause 6.3.2.2, recommends including additional items in the audit plan:
- Roles and responsibilities of audit team members and accompanying persons
- Allocation of resources to critical areas of the audit
- Audit methods and sampling plans
- Identification of the auditee's representative
- Working and reporting language
- Audit report topics
- Logistics and communication arrangements
- Measures to address uncertainty
- Matters related to confidentiality and information security
- Follow-up actions from previous audits
Elements of the Audit Planning Process
- Identification of authority
- Internal sources (e.g. organization, hierarchy)
- External sources (e.g. contracts, standards, regulations)
Determination of Audit Purpose
- The purpose of the audit is determined by the client or designated person
- The purpose sets the tone of the audit and affects most aspects of the audit process
- Examples of audit purposes: compliance, identification of opportunities for improvement, conformity to ISO 9001, etc.
Determination of Audit Type and Scope
- The scope of the audit is developed in conjunction with the purpose statement
- The scope establishes the boundaries of the audit
- Examples of scope statements: first-party, second-party, and third-party audits
System and Process Audit Scopes
- A system is a collection of processes or elements linked to achieve a common purpose
- Process-based management system standards require definitions of processes and their sequence and interaction
Requirements to Audit Against
- Requirements can be formal (e.g. government regulations) or informal (e.g. organization documents)
- Examples of internal requirements: written policies, procedures, work instructions, and company specifications
- Examples of external requirements: customer specifications, industry handbooks, and published guides
Determination of Resources Required
- Resources needed for the audit are determined by the purpose, scope, and criteria
- Factors to consider when selecting an audit team:
- Number of auditors needed
- Time frame for the audit
- Budgetary concerns
- The International Accreditation Forum (IAF) has issued guidance on determining the number of auditor days
Auditor Selection
- Factors to consider when selecting an auditor:
- Skills and qualifications
- Experience and training
- Knowledge of audit criteria
- Ability to perform specific auditing tasks
- Freedom from biases and conflicts of interest
Audit Related Documentation
- Auditors observe, examine, and report compliance and conformance by assessing systems, processes, and products against documents related to the requirements
- Examples of audit-related documents:
- Manuals and procedures
- Forms
- Plans
- Documents for each project/order
- Other documents (e.g. flowcharts, process maps, certificates of compliance)
Logistics
- The logistical plan should include:
- Timeline for arrival, meetings, and interviews
- Location and time of the opening and exit meetings
- Request for an audit team meeting place
- Equipment and special requirements
- Travel plans and hotel arrangements
Auditing Tools and Working Papers
- Preparation of audit checklists, guidelines, and log sheets
- A checklist is a set of notes and instructions about specific areas, with specific questions to ask and specific techniques to use during an audit
- Guidelines and log sheets are additional documented instructions that provide additional information for conducting the audit
- Sampling plans and strategies
Working Papers
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Working papers are an aid to the auditor and should not restrict the scope of the audit activities or hinder the effectiveness of the investigation or report
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Examples of working papers:
- Related audit procedures/instructions/guidelines
- Sampling plans
- Log sheets/forms
- Pertinent audit standards
- Questionnaire
- Audit checklists
- Forms to record negative results
- Attendance record form### Auditing Methods and Process
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The process method involves tracing the path of a transaction backward or forward through the process to gather facts about what, who, where, when, why, and how an action was performed.
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The process method is effective in identifying weaknesses within an organization's management system, securing appropriate inputs, and achieving output objectives.
Process Method
- Uses a flowchart, process map, or PFD as a guide during the audit.
- Tests the sequential steps and interaction of activities and processes.
Conducting Effective Audits
- View the management system as a set of integrated processes.
- Adopt the process approach for audits.
- Add value by looking at more than just conformity.
- Evaluate the linked processes for their "effectiveness".
- Verify process controls and identify any process risks.
- Determine opportunities for improvement.
Department Method
- Focuses on the entire operation of one department or function.
- Reviews numerous elements within the department or function.
- This auditing strategy touches on almost everything in an audited facility.
Element Method
- Refers to any element of any standard or the auditee's management system.
- Examples of elements include 18 elements from 10 CFR 50, Appendix B, 10 elements from 10 CFR 830, Subpart A (120-122), categories from the Malcolm Baldrige National Quality Award, and elements (clauses) from the ISO 9001 QMS standard.
Discovery Method
- Also known as random auditing.
- Investigates what is currently taking place and reflects prevailing work procedures.
- Offers no discernible pattern to an audit, and an auditor can become disoriented or spend too much time in the facility.
Communication of an Audit Plan
- The date and logistics of the impending audit should be confirmed and recorded.
- Notification is done by memo or published schedule for internal audits, and by letter for second- or third-party audits.
- The notification letter or memo should be addressed to the senior person in charge of the area to be audited or their designee.
Distribution of an Audit Plan
- Members of an audit team and the auditee receive copies of the audit plan.
- The auditee is responsible for distributing the audit plan within the organization to be audited.
- Several parallel activities are involved in preparing an audit plan, including scheduling the audit, notifying the auditee, and lining up audit resources.
- Once the audit plan is prepared, it is formally communicated to the auditee.
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Description
This quiz covers the elements of the audit planning process, auditor selection, audit-related documentation, logistics, auditing tools and working papers, auditing strategies, and communication and distribution of the audit plan.
