2 replies to this topic

[Quality Assurance Flavours]

Dear All,

 

During our last audit,we got some NCs related to documentation and record keeping. While doing the root cause analysis using Fish Bone diagram am not able to understand that what should be documented  as root cause analysis and corrective action.

 

Some of the NC s are given below:

 

1. No technical agreement available between the company and service provider-

 

2. Signatures missing on some records-

 

3. Some SOPas are very old and important points are missing in those documents

 

Thanks in advance.

 

Regards,

Charu Tyagi

[dstout]

1. No technical agreement available between the company and service provider-

 

I would have a service provider approval/annual review in place to cover this NC. For the root cause 5 why's can help or the fishbone as well...Why was there no technical agreement?

 

2. Signatures missing on some records- This is a training issue which will need addressed by training the people responsible for signing the documents, perform retraining with these departments and randomly audit the process in the future.

 

3. Some SOPas are very old and important points are missing in those documents - document control and review should catch these items, maybe your program needs some refreshing. 

 

Ultimately to perform a true root cause analysis meet with the departments involved and fill out your fish bone or 5 why's, come up with corrective actions and audit those actions for confirmation that the actions taken appropriately address the NCs. 

[Charles.C]

Dear All,

 

During our last audit,we got some NCs related to documentation and record keeping. While doing the root cause analysis using Fish Bone diagram am not able to understand that what should be documented  as root cause analysis and corrective action.

 

Some of the NC s are given below:

 

1. No technical agreement available between the company and service provider-

 

2. Signatures missing on some records-

 

3. Some SOPas are very old and important points are missing in those documents

 

Thanks in advance.

 

Regards,

Charu Tyagi

As Indicated in the previous Post, one well-established/well-documented  Procedure is to repetitively apply a "Why" to each of 1-3.

 

This hopefully leads to a fundamental   "defect" which is the so-called "root cause".

 

The success of this relatively simple approach may depend on your specific answers to the question{s).