Establish an Internal Audit Program

Choose your audit team

You will want to have a number of trained internal auditors for your audit program. You will be auditing each area of your facility once or twice a year, with an audit team of 1 to 4 auditors depending on the size of the area. You will want to have enough auditors trained so that the auditors will not audit their own area, and so that you are not pulling one person away from their work too often. A general guidance number is 10% of the total number of employees; a company with 50 employees would train 5 auditors, and company of 100 would train 10. As the number of employees goes up, the percentage would go down.

Look for employees that have a strength in investigating issues and that are good communicators. The better people skills the auditors have, the smoother your audits will be performed.

Audit Tips

Internal Audits are a Quality Management System’s best friend. Audit findings lead to great improvement in the effectiveness and efficiency of the system. How can you make your internal audit program work for your organization? Here are some tips to help get the most from your internal audits.

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 an overview of the area being audited or is it to concentrate on a specific system within the area?
• Determine the purpose of the audit - is it to comply with government regulations, quality standards, internal procedures and system?
• 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 what was done well. Second, address the nonconformances and ensure the auditees understand the nonconformance 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 correct 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.

Involving people creates a feeling that everyone is a vital contributor to the goal of the company - compliance.

Auditing when there is no Documented Procedure

With the new documentation requirements giving the responsibility of determining what documents are needed for control of processes, it will become part of the auditor's responsibility to determine if the necessary procedures and work instructions have been documented. How can an auditor determine if a process is controlled if there is no procedure or work instruction?

As an auditor, you must evaluate if the process is being performed consistently, with consistent and acceptable results. An auditor can do this by asking several of the people performing the process questions. Ask the people the questions individually, so they do not influence one another's' answers. If the process is in control, the answers will be consistent. Some sample questions:

• Can you explain the steps to this process?
• What measuring and monitoring is required for this process?
• What are acceptable ranges for the equipment?
• What are the acceptance criteria for the product?
• What records do you need to complete for this process?

Ask enough people to give you a good idea of how much the process varies between each individual performing the process. If the answers vary, there should be a procedure. The need for a procedure will generally depend on the complexity of the process and the training of the people responsible for the process.