January 2012 Newsletter

Print

The 3 Stages of Effective Internal ISO Process Audits

ByHelmut Jilling, Smithers Quality Assessments Auditor, consultant and trainer   

Without effective checklists for use in internal audits, auditors have little guidance. Effective checklists define a good process audit without limitations of specific questions.

ISO 9001-based standards require audits to follow a “Process Approach.” It is not enough to audit the ISO standard, procedures or manufacturing. Assess each process for conformance and how it interacts with others, and seek improvements.

Process Approach audits must be scheduled to the processes defined in your QMS. The schedule should not be based on the clauses of the ISO standard, or your procedures.

Process Audits should address 3 important stages: 

  • Stage 1 – Prep the Audit (Desk Review)
  • Stage 2 – Audit the Process and Linkages
  • Stage 3 – Write Executive Summary Audit Report

Stage 1 - Prepare the Audit (Desk Review)

Another key solution is good prep and organization. Before auditing, prepare thoroughly! An hour preparing will make you a better auditor, and a more effective audit. Poor prep strips value from the audit. Good prep saves time.

Gather relevant documents and records for the process you are auditing, such as metrics, turtle diagrams, flowcharts, instructions, etc. Review these documents and mark what you plan to audit. Also, review relevant sections of the ISO standard. If necessary information is not available, it may be an audit finding.

Prep these documents well. It is easier to audit if the information is organized. Mark key parts as questions and audit trails. Are documents clear, accurate and easy to understand? Do you see Problems? Errors? Omissions? Write answers and findings directly on the pages next to your questions.

Allow adequate time. Prepped documents will guide your audit trails and linkages. Prep well, it will save time and make a better audit.
When you finished prep, print the pages, and organize them into a logical flow. Then move on to the Audit stage.

Stage 2 - Audit the Processes and Linkages

Now, audit the documents just as you prepped them. This is the key part of the audit. Follow the sequence of the process from start to finish; as well as linkages you identified. Organize well. You will have many notes to follow up.  

Simply work through your pages and questions in a logical flow. It will lead you through the main process, and links to related and supporting processes.

Review metrics and performance with appropriate managers, supervisors and operators. They should know how things are running, objectives, customer issues, problem areas. If they do not, the requirements may not be met.

Training, skills and competencies are always a potential area for improvement. Is training effective? Pay attention to newer employees or people who do not demonstrate good skills. If people do not seem to be “up on their game,” collect names to review with the Training Process Owner.

Linkages and Interactions with other related processes and support processes are also important. Mark findings and issues as you go. Organize your notes. Findings will be reported to management.

Stage 3 – Write Executive Summary Audit Report

A good audit report is the main output of the audit. Prepare a meaningful report with good content so the Process Owner understands the auditor’s findings, and can take suitable actions.

Your report should be typed, and describe findings clearly, provide objective evidence, and classify them as Corrective Actions, Preventive Actions, or OFIs. The auditor should also summarize thoughts, observations and conclusions. These should be formally documented as part of the Audit Report.

Audit Meeting: Review findings with the Lead Auditor and then present to the Process Owner and Management at a closing meeting. File the final audit report and all supporting audit materials and notes.

 

 

Our Complimentary Toolkit Can Improve Your Company's Audit Depth and Findings

The new ISO 9001 Auditor Process Toolkit will help ensure your Process Audits are accomplishing more than simply checking whether people "are following their work instructions." It will help you determine if the Process is meeting objectives and whether customer needs are being met, identify potential bottlenecks and more. It includes easy-to-understand guidelines, examples and sample outlines.

Download Now.