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Documented Information

When auditing documented information it can be a tedious task to determine if whether or not the organization is in the guidelines. Remember documented information, in the new standards, can be any type and media as long as it is controlled per the Standard requirements, and any other requirements invoked by the organization.

One question that comes up during auditing is what about software generated programs. Do I need to put a document number and revision control? The software is controlled by the software version. Documents created by that said software is controlled that said software. You need to identify this type of control in your documented information process.

QARMA Consulting can help with your system, whether it be a QMS (Quality Management System), EMS (Environmental Management System), etc. or IMS (Integrated Management System).

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What Auditors Look For?

The purpose of an audit is to ensure the organization’s QMS and its processes are effective. Auditors have different approaches on what they are looking for. However, they review documented information for the processes they are auditing to familiarize themselves with the audit and to ensure the organization is meeting the standard requirements and their requirements. Documented information could be manual, procedures, work instructions, forms, and etc. It, also, can be any media, such as web based tools and ERP systems.

Auditors need objective evidence to determine whether or not the the organization is meeting the requirements or not. This starts with documented information and continues in the process. Are personnel performing the processes meeting the requirements? This where auditors ask the personnel performing the process questions.

What auditors look for? Here are some tips to help you:

1. What are your roles and responsibilities?

2. What do you do?

3. How do you know documents you are using are controlled?

4. What documents are you using in your job?

5. What are you currently working on?

6. If I make an error on a document or record, what is the proper way to correct it?

7. What is the Quality Policy and Quality Objectives? How do you meet them? What do they mean to you?

8. How do I report customer feedback?

9.     What equipment/software do I use for my job?

10.    What is continual improvement?

Of course these are not all questions auditors ask. It depends on what processes you are performing within the organization.

QARMA Consulting offers auditor training courses. Come found out more.

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Auditing – The Best Practices

Every year, many companies prepare for an audit just before the audit. This means that personnel are scrambling to ensure paperwork is completed and the organization is following the standard. They cross their T’s and dot their I’s to be ready. Too often, personnel get discouraged because of misconceptions of an audit’s purpose. The fear is that the audit will scrutinize their work when in fact an audit is quite simply about the process.

The whole point of the audit is to find process deficiencies, including risks and reduce the risks or eliminate them through mitigation and corrective actions. The audits help the organization improve their QMS (Quality Management System) and its processes. The audit is used to ensure organizations are following the requirements of the quality standards, such as ISO 9001.
The best practices in your QMS is to do what you say you do, which involves making sure that your documented information (manual, procedures, etc.) describe the process by which you meet the standard requirements. If you restate the requirements in your manual, then what is the added value in your organization?  How can you ensure personnel within the organization are following what you require? What is the purpose of defining your system if you just restate the requirements
An organization writes a manual that loosely describes how they meet the requirements in some processes while in other processes the organization restates the standard requirements. Their auditors are not familiar with the standard requirements and are auditing the organization’s quality management system based on their manual. Are they in fact really reducing risks and ensuring QMS and its processes are meeting the standard requirements? Auditors need to review the facts.
Best tips for an auditor.
  1. Review the standard requirements and then match up the process to the requirements. Is the organization meeting that requirement? What is the objective evidence?
  2. Is the organization meeting the requirement, including requirements of interested parties that affect the QMS? What is the objective evidence?
  3. Always record your objective evidence and ensure enough samples for consistency. For example, if you are reviewing ‘nonconformity and corrective actions’ process, are you looking at three corrective action records? Are all three corrective action records completed consistently, following the standard requirement and the organization requirement?
Steps for an auditor:
  1. You want to prepare for the audit.
  2. Review the standard requirement for the process you are auditing.
  3. Review where in the QMS and its processes where the organization defines how it meets that requirement.
  4. Review completed records for that process.
  5. Interview personnel performing the process.
  6. Record objective evidence and take samples.
The auditor needs to observe his or her surroundings because a great deal of sub-processes are involved. If you are auditing production process, for example, you need to look at the supporting requirements that are used in the production process, such as, but not limited to: documented information, awareness, training, and monitoring and measuring. Remember you do not have to audit all processes at once, but new auditors need to audit more frequently to gain more experience within the first year.
QARMA Consulting can help you become a better auditor through our internal auditor training courses. We are currently updating our website to enhance user experience.
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