Internal Audit Tips

Kathy Stock, Quest Analytical, Inc January 2001

Internal audits help you learn about your company and find areas that are working and areas that are not working as planned. Whether you do internal audits to stay compliant with government regulations or quality standards, whether it is your first audit or your 100th, below are some tips to help the process. Before an audit

Make sure the authority of the audit team is established - this will increase the cooperation from auditees. Decide what areas of the company will be audited and the frequency of the audits. Prepare a yearly audit schedule and distribute. Develop an audit plan. Decide what other audit resources are needed - checklists, other auditors? Determine the purpose of the audit - is it to comply with government regulations, quality standards, internal procedures and systems? v Define the scope of the audit - is it an overview of the area being audited or is it to concentrate on a specific system within the area? Hold a meeting with the auditors to discuss the plan, purpose, and scope of the audit. Read the documents you will be auditing against. Know what they say. Develop questions to ask the auditees. Conduct an opening meeting with the auditees.

During an audit

Be professional at all times. Avoid being judgmental. Follow safety procedures, clean room procedures, and all other required procedures. Explain the purpose of the audit to the auditees. Answer questions or discuss compliance problems brought to your attention by auditees. Be flexible - if you find a potential problem not within the scope of the audit evaluate the potential risks of the problem if left unaddressed. Encourage honesty with the auditees.

After the audit

Hold an auditors meeting to discuss the closing meeting content. Hold a closing meeting with all auditees involved with the audit. First, point out what was done well. Second, address the nonconformances and ensure the auditees understand the nonconformances and what part of the standard is not met.

Issue the audit report in a timely manner. Encourage auditees to decide on the corrective actions. Allowing auditees to have input will give them ownership in implementing changes. Assist those responsible for completing the corrective actions with setting reasonable deadlines. The corrective action deadlines may vary depending on the severity of the noncompliance. Be available and willing to help the auditees. Ask for feedback on how you and your audit team were perceived - adjust your approach if necessary.

One last tip: Involve people! Use audits as opportunities to train others. Ask for a volunteer (who is not an auditor) to walk through the audit process with you as an assistant. This will provide others with a better understanding of what audits are and why they are necessary. Invite all the auditees to the closing meeting. Having been an auditee, I know it helps to hear audit findings firsthand, the positive as well as the negative. Involving people creates a feeling that everyone is a vital contributor to the goal of the company - compliance. Process Auditing Recently we have been receiving questions regarding process auditing and what it means. If you are auditing your quality management system by process or area and then auditing all the applicable ISO elements while in that area, you are doing process auditing. Process auditing involves looking at an entire process including inputs and outputs and related requirements to determine if you are doing what you say you are doing. If you are auditing your quality system by ISO elements throughout the organization you are not set up currently for process auditing. To start: set up a table with your processes or areas listed across the top. Along the left hand column list the ISO elements. Put a checkmark in applicable boxes. For example, document control is audited in all areas while purchasing may only be audited in the purchasing department (if that department is the only place purchasing is performed.) You can set up a column for management that includes all the management issues and also elements such planning, customer feedback, internal audits and corrective/preventive actions. Include all those elements not primarily addressed within the departments. Second, set up an audit schedule based on areas. Remember to audit according to the importance of the area and past findings. Production is always a critical component, but if purchasing is going well and has had few findings in the past it may be audited less

frequently. To receive example pages of both spreadsheets, please contact us. ISO Audit Program Outline Managing the Audit Prepare a procedure. Prepare a schedule. Implement the audits. Keep audit records. Initiating the audit Clearly define objectives, scope and audit criteria. Determine the audit team. Notify the auditee, establish communication. Perform an initial document review. Audit Preparation Prepare the audit plan. Assign audit team responsibilities. Locate relevant reference documents. Assemble audit checklists and forms. Individual auditors should review information related to their assignment. Auditing Activities Hold the opening meeting. Collect information. Evaluate evidence. Document audit findings. Prepare for the closing meeting. Hold the closing meeting with the auditee. Reporting on the audit Prepare the audit report. Provide an accurate record of the audit. Distribute the report. Keep records of the audit.

Audit completion The audit is completed when all activities in the audit plan have been concluded, including the distribution of the approved audit report. Audit follow-up The auditee is responsible for initiation any corrective actions. Corrective action implementation should be verified. A follow up report should be distributed in a manner similar to the original audit report. Auditor qualification You define what your company will require for auditor qualification. You may require more of your lead auditors, for example, performing a certain number of audits before becoming a lead auditor or to take an RAB approved Lead Auditor course. Why Become an Internal Auditor?
Richard Hjerpe, Quest Analytical, Inc September 2000

The Internal Auditors perform a very important function by letting management know how well their Quality Management System is working. This is important for the company, but what's in it for you? As an Internal Auditor, there are some advantages you may not otherwise have.

You have the opportunity to see other areas of the company and what goes on there, since you do not audit your own area. You get to meet other people in the company. Other people get to know who you are. This can be important as you are looking for advancement. It is a break from your normal routine.

If you have been auditing for a while, and you are finding it repetitive and kind of reoutine, there are things that you can do to make it more challenging.

Peel the onion back and dig deeper into things. Don't always accept what people say they do, say "show me". Auditing is a sampling, so try to investigate new areas. Review procedures and work instructions and check items you haven't checked previously. Don't forget, when you convert to the new revision of the standard (ISO 9001:2000) there will be new challenging requirements to audit.