wissen-der-organisation-iso9001-dqs-mitarbeiter gibt erfahrung weiter

Corrective Action

Company ABC wants to be certified under ISO 9001 so they come to DQS and the audit was planned accordingly. Then, the audit was carried out effectively by a team of professional auditors and company ABC showed great cooperation. However, nothing is perfect in this world, there was some improvement raised by lead auditor. Since company ABC is new to ISO 9001, they do not know how to encounter for non-conformance raised, so the lead auditor explains briefly to them.

 

After an audit, the lead auditor will classify the audit findings into strengths, opportunities for improvements and non-conformance (minor and major).

 

Strengths (str)

  • Conforming, all requirements are fully met and significant strength was identified, evident through excellent results.
  • Example:
  1. Effective filing system for hard copies documentation, easily traceable and retrievable.
  2. Updated competency matrix in a timely manner to ensure that the employees are competent for the position.
  3. Organization context is comprehensive regarding its purpose and organization strategic direction, action to mitigate risk and opportunity being address for each department and process.

 

Opportunity for Improvement (OFI)

  • Conforming, suggestions that can help your management system or can potentially prevent a possible non-conformance in the future.
  • Example:
  1. Organize Management Review meetings more frequently.
  2. Developing a better method for keeping track of any assignments made during Management Review meetings.
  3. A better approach to deliver and collect customer satisfaction surveys.

 

Minor non-conformity (nc)

  • Minor non-conformity issues don’t immediately affect the performance or operations of your business. But they do indicate that further action needs to be taken to avoid major non-conformance issues.
  • Several minor nonconformities may affect the integrity of the management system and become major nonconformity.
  • Example:
  1. A missing training records.
  2. Supplier was selected not according to it capability to deliver organization requirements.
  3. Measurement equipment was not calibrated according to planned schedule.

 

Major Non-Conformity (NC)

  • Major non-conformance issues put the abilities of your management system into question. These issues can lead to an inability to use products and services, access important data for management and customers, or create safety issues.
  • Example:
  1. A failure to address a drop in quality.
  2. Not properly monitoring and measuring processes and procedures.
  3. Product specifications not meeting client requirements.

 

Non-conformance Reporting (NCR)

Non-conformance reporting (NCR) provides information that allows you to develop corrective action to address them quickly and easily. This creates opportunities for you to improve the areas of your business that are directly related to quality management. This helps you provide greater satisfaction to both customers and investors over time.

 

You need to submit corrective actions and any supporting evidence before the date stated on the non-conformance report. Failure to submit suitable actions within given time may result in suspension.

 

Corrective Action

When a finding of nonconformity is raised, corrective actions need to be implemented in order to make sure your products or services is compliance to a specific standard requirement.

 

The “Corrective Action Plan” shall include:

  • The action completion date and responsibilities
  • Any rework or recall of nonconforming product
  • Corrective actions to contain the non-conformance
  • Root Cause information to highlight how the non-conformance occurred
  • Action to prevent the non-conformance from reoccurring

 

Seven-Step Corrective Action Process:

  1. Define the problem
  • Explain the who, what, when, where, and why.
  • Describe the expected outcome and how the issue can be resolved.

 

2.       Define the scope

  • Give context to the size of the problem.

 

3.       Containment Actions

  • Make a short-term fix to stop the problem while searching for the ultimate cause and fix.

 

4.       Identify the Root Cause

  • Identifying the root cause using specific root cause analysis techniques available (e.g. 8D techniques, 5Why)

 

5.       Plan a Corrective Action

  • Create measurable, achievable solutions with realistic deadlines focusing on the root cause.

 

6.       Implement the Corrective Action

  • Implement your actions and manage those actions to completion.

 

7.       Follow up to make sure the Plan worked

  • Document and close out the process with a debrief to determine what was done and inform the team of the changes.
  • Give sufficient time to ensure that the problem does not manifest again.
  • Capture any lessons learned.

 

Finally, company ABC gets the point and understands what it is about NCR and corrective action. Company ABC promise to do their best to close the NCR within given time  in order to be certified for ISO 9001 and improve the reputation of their company, hence attract more potential customers.