How many times the quality agreement has been invoked?

v9991

Trusted Information Resource
#1
we put "huge/LOTS" of amount of time and effort in signing off the QA. Time for aligning the both QMS towards respective accountabilities; then it is wetted by the legal teams.
my query is
1) are the processes to maintain/monitor the compliance effective? Logically, they have to be integrated into Change control system of respective products, and SOPs to ensure that partner/customer is notified of respective changes.

2) how many times/often they are found to be really functional. (other way is what is rate of non-compliance)
3) what are the activities/process/situations/suppliers in which we find the non compliances?
thank you for your thoughts.
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Good day v9991,

I do not understand your meaning when you say "then it is wetted by the legal teams."

Are you asking us if our management systems are effective?

I can offer in my fairly recent past, moderately effective. When auditing I almost always found nonconformances, some of which repeated and some which revealed a lack of awareness.

In one case we were able to recognize that the corporate IT group had not been included in the QMS planning or the discipline needed in change management. Specifically, they pushed through a switch from Lotus Notes to GMail, and some sites lost a great many documents and functionality that could not be migrated from Lotus Notes to another database before the switch was completed. The IT group introduced Google Docs and some managers migrated their records to this new platform without planning for, or defining retrieval in their records retention procedures.

In another case we were able to recognize (again through internal audits) that planned maintenance on production equipment had been set up on a production software system that had crucial flaws - specifically, the overdue notifications could be silenced by opening and closing an unrelated repair. In addition, once that happened the software would not schedule the new PM. As a result, a great many PMs were chronically overdue, some for years.

I was able to raise awareness in IT through the first example, but to my knowledge they are still using Google Docs, the Lotus database files are still lost and managers are still storing crucial records without planning for what to do (call Google?) if their records disappeared. So, no resolution.

In the second case a great deal of effort was put into fixing the software glitches, but repeats in subsequent audits showed the issue was still there. No resolution.

Top management has repeatedly cut head count without updating the systems, which largely run on Word and Excel. People are working harder, not smarter. Resources. Moderately effective.

A QMS is supposed to be a structure of good-sense practices that bring recognizable value. When set up in a manner that is comfortable to use yet includes the necessary disciplines to facilitate good management practices, value is easily enough recognized but people must learn to notice the value in order to appreciate it.

I hope this helps!
 

v9991

Trusted Information Resource
#3
thank you Jennifer for a very detailed response.

I do not understand your meaning when you say "then it is wetted by the legal teams."
Are you asking us if our management systems are effective?
First i was referring to the quality agreements between supplier and manufacturing unit.
1. when i said, cleared by legal team, i meant, if the context and wordings are inline with the commercial agreements. (viz., differences of outsourced partners/suppliers vs inlicensed suppliers etc)
2. yes i was trying to get some inputs on the effectiveness in systems supporting the quality agreements .(viz., as outlined by the QA, there are instances which require pre-approval, intimation to the customers , do they really happen, how do both(customer and supplier) are ensuring compliance)
 

somashekar

Staff member
Super Moderator
#4
we put "huge/LOTS" of amount of time and effort in signing off the QA. Time for aligning the both QMS towards respective accountabilities; then it is wetted by the legal teams.
my query is
1) are the processes to maintain/monitor the compliance effective? Logically, they have to be integrated into Change control system of respective products, and SOPs to ensure that partner/customer is notified of respective changes.

2) how many times/often they are found to be really functional. (other way is what is rate of non-compliance)
3) what are the activities/process/situations/suppliers in which we find the non compliances?
thank you for your thoughts.
Due to non-compliance .... ?
Well you will see it when you do a serious non-compliance, that takes a regulatory route. These are backups to cover both parties and the understanding must be driven down to executing levels.
Regulatory too needs them to ensure controls are planned per regulatory requirements.
When you do not make some things happen per the agreement, it does not mean that the corrective action must be driven quoting the agreement.
When you keep communication with customers direct and clear, there is less chance that the agreement clauses needs to be invoked.
Such agreements are also re-signed once every period (say like 3 years) to keep everyone on the same page with regard to customer - manufacturer obligations.
 
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