We all hate deviations and customer complaints, so does ISO 9001 QMS. Any rejections, customer complaints, deviations against established processes / applicable standard(s) / customer requirements / contractual requirements / legal – statutory – regulatory requirements or organization’s standards can be addressed as a non conformity.
How effectively you address a non conformity may become a distinguishing factor between a successful and not so successful company.
ISO 9001:2015 standard wants an organization to identify a non-conformity, identify correction, identify root cause for the NC, evaluate possibility of taking corrective actions, take corrective actions and evaluate effectiveness of the corrective actions.
Non conformance module of Effivity ensures you meet various requirements specific to NC across the standard in an effective, efficient and simple manner. Below steps demonstrate capabilities of this module and how you can comply with requirements with respect to various related clauses of the standard:-
An intelligent module level home page welcomes user to the module with all compliance options available in the module on left side menu. This home page shows quality objectives for the department, available / recently changed documents, real time graphical analysis on the basis of data / information captured in the system, alerts for pending tasks, quick links for common / regular tasks etc. Module level help is also given at appropriate places.
1. Define the non-conformance by capturing details / specific information for various deviations.
2. Assign the non conformance to specific category by defining nonconformance type as compliant, process deviation, Internal audit NC, rejection etc. Each non-conformity can be assigned to a person in the organization and upon assignment, this person will get alert / auto reminders.
3. Capture correction taken for each non conformity. Correction is the immediate solution to the problem / NC.
4. After correction is taken, still the same problem / non-conformity may reoccur. To ensure we stop the same non-conformity from occurring again, this module of Effivity allows you to brainstorm and identify root cause. Actual reason which was behind the particular non-conformity.
5. After root cause has been identified, as per ISO 9001:2015 standard, corrective action should be taken wherever possible. This will eliminate root cause and will ensure due to the same root cause, same kind of non-conformity does not reoccur. In this step, you can define proposed corrective actions.
6. After actions are taken as per proposed corrective action, actual corrective action with all relevant details can be captured.
7. A very critical step in the entire non conformity management is to ensure that an organization verifies effectiveness of the corrective actions taken. This can be done by verifying, same kind of non-conformity due to same root cause did not reoccur. Details of such evaluation can be captured here and a non-conformity can be marked as closed.
8. Data analysis capability of the module also generates insightful statistical analysis that enables an organization have required information for an MIS readily available.
Comprehensive capabilities of this module ensures all the requirements pertaining to non-conformity, correction, root cause analysis and corrective actions are addressed in a quick and simplified manner while achieving 100% compliance to of ISO 9001:2015 standard. Contact us at info at effivity.com for further information or visit www.effivity.com to subscribe to our award winning and one of its kind of ISO 9001 compliance software.