How to prepare a perfect QMS Audit Check List 

A QMS audit checklist is a very useful & important document for QA auditors, who are new or experienced. It is therefore important to know how to prepare a good quality audit check list and use them to overcome some of the limitations and drawbacks of check list. In this article, I wanted to give some highlights and useful tips on preparing an auditing checklist for the benefit of quality assurance & quality control auditors

What is a Check List?

A list of something that can act as an “aides-memoir”. 
For example when you are requested to buy some items from a supermarket, you would prepare a list. This will help you to never miss an item during your purchase.
That’s how a checklist helps you to remember things and will let you not miss any item during the purchase process

So, what is a Quality Audit check list?

A QMS Audit Checklist helps auditors to organize, plan, conduct and report audit observations in a Consistent manner.
Even though Check list is not mandatory, It is highly recommended as it provides a Systematic approach to auditing.

Almost all certification bodies use check list in some form or the other. Let’s see what purpose a quality audit checklist serves as an audit tool.

Purpose of an Audit Check list is:

  •    To assist memory-nothing is missed inadvertently;
  •    To ensure comprehensive coverage of  all  applicable element ;
  •    To ensure continuity/repeatability/consistency of the audit;
  •    To manage time;
  •    To organize note taking; and subsequent review by CB assessors. Can become part of an Audit report. 

Drawbacks of a Quality audit checklist:

Audit Check list may have some drawbacks unless used effectively and may lead to the following

  1. May lead an auditor into a predetermined sequence of thought and questions and may prevent natural progression of audit. 
  2. If used as a “Tick List”, may lead to limiting questions that generate “yes/no” answers.
  3. If directly referred and questions are read from the check list. This may lead to a boring and rigid auditing process.
  4. Auditors will possibly perceived to be performing a “Clerical “task than a Systematic process approach audit
  5. Auditors might look silly and give an impression of lack of competence and ability to perform a value added audit

How to Overcome the Limitations of Quality Audit checklist?

  •  Prepare a generic type of verification points while preparing the  Audit Check List
  •  Familiarize the organization , processes and documentation thoroughly so that you can adopt a process approach audit
  •  Never  look at the check list and read questions from Checklist
  •  Move on with a process approach , focus on Inputs, Activities , Controls and Outputs -take notes in relevant places in Check List, This is something like “everything has a place,” and “everything is in its place”
  •  Add specific check /audit points to the standard  QMS audit Check List based on the Stage 1 audit to be verified/covered during stage 2 –conformity assessment audit

Certification bodies may have thousands of organizations as their certification client and the CB’s certification decision committee members need to review all the audit reports and other associated audit documents/records.

Imagine,  unless there is a definite place to look at,  for certain piece of  information (Say control of documents), the reviewer has to go through the Audit Notes over and over again, , each time for each information ! If there is a space in the  audit check ist, the reviewer will directly look at the particular place, life becomes easy!

If the information is not there or the space is blank, it may be possible that the element has been missed during the quality audit. This is how use of a QMS audit checklist can bring consistency, and can give evidence of a comprehensive coverage of all elements of the management system under scope of audit. 

Let’s try to make a short check list on –say ” Control of documents” Cl. No 4.2.3 of ISO 9001:2008 standard which says:
Documents required by the quality management system shall be controlled. 

A documented procedure shall be established to define the controls needed
a) To approve documents for adequacy prior to issue,
b) To review and update as necessary and re-approve documents,
c) To ensure that changes and the current revision status of documents are identified,
d) To ensure that relevant versions of applicable documents are available at points of use,
e) To ensure that documents remain legible and readily identifiable,
f) To ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, &
g) To prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are  etained for any purpose

A Good QMS audit Check list can start something like this:

Q1 Is there a process to identify QMS documents those need control by the organization? 
Or
Q1. Has the organization identified documents those may affect their QMS and need control?

Comments: There may be hundreds or thousands of document the organization uses and all of them does not need to be controlled. For example there are some old standards or handbooks used by the company for imparting generic knowledge and these standards is not used for developing  , accepting or rejecting a product, These  type of documents do not need control.

Next question could be
Q2. Is there a documented procedure to define control of documents?
Q3. How documents are approved prior to issue?

And so on and on. 

Make these as verification points, based on the requirements of the standard. You can take notes next to these questions /verification points to seek/provide evidence of conformity. The check list becomes a good place to take note for consistent reporting.
You may even make a good check list in the following manner. Just write verification points.

  1.     QMS Documents those need control :
  2.     Procedure for control of QMS documents :
  3.     Approval process of QMS documents prior to issue :
  4.     Process of review, update and reapprove QMS documents:

Perfect check list. You can take notes next to these verification points to seek/provide evidence of conformity.

Now Let’s see how a Silly audit check list looks like !

  Q1. Do you have a procedure for control of document?

  Q2. Can you show me the procedure?
  Q3. Can you explain how the documents are approved prior to issue?
  Q4, Can you show me who has approved this procedure/document?

Even though you will ask questions this way in the interview process, you are not expected to develop questions in the form of a check list and read out or refer the check list to ask a question the way it is written there. This would look funny, immature and unprofessional for an auditor.

Final Thoughts:

Remember- Check list is your servant-and you are the master. 
What is your way of preparing a Quality management audit checklist?

If you have a question, please write to msr@tr-cbl.com

 

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