QMS AUDIT PROCESS

How Should a QMS Audit Process be?

QMS Audit

QMS means quality management systems which is a complex and comprehensive collection of too many procedures, processes, reports, analyzes and of course people attitude.

 Parameters Affecting QMS Audit

Conducting QMS Audit is not complex as the system itself, if it is well managed by auditor. Most auditors and companies skip one of the most important step of Audit process, standardizing ways of working.

How can an audit process be standardized when considered that there are too many parameters .Well first the parameters needed to be identified.

  1. Auditor: Auditor’s personality , knowledge, experience.
  2. Environment: The size of the place to be audited.
  3. Attitude:The reaction of people in the place to be audited.

Mainly these parameters are affecting an audit consistency .Even it is very difficult to maintain consistency for same auditor for same factory or place to be audited ,there must be at least a plan to standardize the ways of working.This plan is named as flowchart of audit process.

The Flow Chart of QMS Audit

The flow chart will not eliminate the risk of different auditors giving different decisions on same occasions but will seriously decrease.

Below you can find a sample of a QMS Audit process flowchart.If every individual (Auditor) follows same path while doing the audit than the outcomes will generally be same.

 flow2

Above flowchart is a general plan to do audit. Making this plan to be workable and more efficient each step should be detailed as to clarify what is to be asked and what answers needed to be taken.

Let’s clarify above flowchart step by step.

Preparation of QMS Audit:

This is actually pre-planning stage. This preparation should be done prior to audit in order to plan the audit day in most efficient way. Therefore below information should be known prior to factory(field) visit;

 

  • Name of The Company
  • Size of the place
  • How many workers working?
  • Contact Name, Address ,Phone numbers of related people
  • Which type of product is produced?

 

Factory Visit

 

Opening Meeting: On this meeting below steps should be followed;

  • Introduction :Briefly introduce yourself and the reason of the visit
  • Confirmation of the information which has taken in advance
  • Planning the audit day including breaks, lunch etc.
  • Ask permission to specific needs of the audit. For ex: if you will need to take photos you need to get a permission in advance because in some factories this is not allowed.

 

Factory Audit (Field Tour)

  • Clarify the questions to be asked for each department in advance.
  • Know what you are looking for and try to get that information
  • If you have found a non-conformity , confirm it on the field with all parties.(The worker,the supervisor and the concomitant employee)

 

Closing Meeting

  • Management should be represented on closing meeting
  • Summarize the day
  • Appreciate people who attend to audit and the people who listen to you
  • Mention about all the non-conformities with the proofs
  • If you have not confirmed a non-conformity on the field do not mention on closing meeting

 

Reporting

  • Create a report for all your findings in detailed that every individual can easily understand.
  • Do not write a non-conformity on the report if you have not mentioned on closing meeting.

CAPAR Reporting

  • CAPAR means Corrective and Preventive Acknowledge Plan or Corrective and Preventive Action Plan.
  • According to this definition, your findings(non-conformities) and actions needed to be taken to correct these findings should be existed on the report.
  • Also the responsible person and the complete date of each action should be noted down.
  • Complete date should be filled by factory related people.

 

 

 

 

CAPAR Follow Up

  • CAPAR follow up can be in two ways , on desktop without re-visiting the field or re-visit.
    • Some actions can be followed and confirmed that has been taken by a photo or a report .On these occasions another factory visit is not necessary.

 

  • Most of the actions actually needed to be seen on field while the production is continuing to decide that action really has been taken or not.

 

 

As mentioned above QMS is a very complex and detailed systems community so to audit these systems community needed a standardization in itself to maintain the consistency of results. If you repeat these steps each and every time you audit a company than 99% audit results will be consistent.