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How to understand correctly the section of 5.11 MOC in API Spec Q1?

lanley liao

Involved In Discussions
#1
Hi,

We have a little confused that we have already modified some documented procedures according to the requirement of nonconformances correction action. During the auditing, the auditor said that where is the MOC activity record. then the document modification applications and approved forms for documented procedures modified were provided to the auditor by us. however, the auditor said that this is not recorded for the requirement of 5.11 MOC. Finally, the auditor wrote in auditing finding that the required records of MOC activities related to the management system procedures were not maintained. hence, how to understand correctly the section of 5.11 MOC in API Spec Q1? How to differentiate between document change and management of change.

I would be greatly appreciated it if you can help me.

Lingli Liao.
April,27,2021.
 
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Thee Bouyyy

Involved In Discussions
#2
Sorry for the late response.

First, I would like to bring your attention to MOC process. 5.11 clearly says that, "MOC is applicable for changes which negatively impact quality."

Here, you are talking about d) Changes to the management system procedures, including changes resulting from corrective and preventive actions.

Now, my question to you is that, "What type of documented procedures you have modified?" "Do you think so that will impact negatively on quality?" "Do you have document change program available?"

You have to clearly write in procedure like this, "For sake of clarity please note that our management / M.R. will decide which change can impact negatively on quality or which change does not impact. M.R. ensures that MOC is required only for changes which negatively impact quality of product. Routine process / person change / termination / promotions are not treated as MOC, provided they do not impact negatively on quality of product."
 

jmech

Trusted Information Resource
#3
Thee Bouyyy has raised a good point. The requirement is to "use the MOC process for any of the following that may negatively impact the quality of the product". His suggestion is one way to handle it that makes sense (assuming that M.R. means Management Representative), provided that the management rep is reasonable in their assessments of which changes may negatively impact quality.

The challenge with this requirement is that whether a change "may" negatively impact product quality is often unclear.

The "changes to the management system procedures, including changes resulting from corrective and preventive actions" clause is a weird one because when you change the procedures due to a corrective action, the change should be intended to improve product quality and should not have a negative impact on product quality.

Document changes shall always follow your document control procedure (per API Q1 4.4.3). Additionally, when a management system procedure is changed in a way that may negatively impact product quality, the MOC process shall also be followed.

Example #1:
If you change your inspection procedure in any way, you must follow your document control procedure.
If you change your inspection procedure to increase the frequency of inspection, this change will not negatively impact product quality, so MOC is not required.
If you change your inspection procedure to decrease the frequency of inspection, this change may negatively impact product quality, so MOC is required in addition to document control.

Example #2:
If you change your "documented procedure to measure customer satisfaction" (required per 6.2.1) to reduce the frequency of measurement of customer satisfaction, the change is required to follow your document control procedure, but it is debatable whether this "may" negatively impact product quality, so it is unclear whether you would be required to use MOC for it.
 
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