Management of Change (MOC)

NDesouza

Involved In Discussions
#1
Hello All,
I am not sure if I am posting this question in the right location for discussion.

I need to roll out Management of Change procedure at a supplier. I have never implemented MOC and I would like to know if anyone has done it before, and if you used a step by step project plan? if so, would you please either share your plan or direct me to where I can get an MOC implementation plan example?
 
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NDesouza

Involved In Discussions
#3
HI, Desouza, This question asked you is a little blurry, and i don`t know that why do you need to implement MOC?
Hello,
I am working on assisting a supplier who wants to implement MOC (Management of Change procedure). They want to have a step by step process for managing changes in their organization.
I am asking if anyone has implemented MOC before and if they can help me by sharing their ideas on how to best implement MOC.

thanks,
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#4
What is the change
Why is it happening
What are risk and regulatory impact
Training for whom?
Impact to the product in the process, in transit, in use?
Verification and validation
A list of all changes from part number or revs to documents and materials.

Tailor the document to fit the companies needs where possible.

From FDA (i) Design changes. Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.
 

Ajit Basrur

Staff member
Admin
#5
Hello,
I am working on assisting a supplier who wants to implement MOC (Management of Change procedure). They want to have a step by step process for managing changes in their organization.
I am asking if anyone has implemented MOC before and if they can help me by sharing their ideas on how to best implement MOC.

thanks,
Does your company have a procedure in place to address these situations? Typically the key steps for managing a change are as follows:

  1. Evaluation of a change
  2. Approval to proceed with the change
  3. Implementation of the change
  4. Review to ensure that the change has been effective
  5. Reviews effectiveness of overall system

If you are at liberty to share the high level change proposal, probably you may get more thoughts.
 

lanley liao

Involved In Discussions
#6
Hi,NDesouza, see the following information about MOC please:
5.11 Management of Change (MOC)
5.11.1 General
The organization shall maintain a documented procedure for MOC to ensure that the integrity of the quality management system is maintained when changes to the quality management system occur (see 5.11.2). The MOC procedure shall address the following:
a) description and purpose of changes;
b) availability of resources;
c) allocation or reallocation of responsibilities and authorities;
d) potential risks (see 5.3);
e) approvals required prior to the implementation of planned changes;
f) notification (see 5.11.3); and
g) criteria for review and completion of MOC activities.
5.11.2 MOC Application
The organization shall use MOC for any of the following when the organization has determined that the change may negatively impact the quality of the product:
a) changes in the organizational structure (see 4.2.2);
b) changes in key or essential personnel (see 4.3.2);
c) unplanned changes in the supply chain of critical products, components, or activities (see 5.6.1.1);
d) changes to the management system procedures; and/or
e) additions to the product offering beyond the organization’s current capability.
5.11.3 MOC Notification
The organization shall notify relevant personnel, including the customer when required by contract, of the change and residual or new risk due to these changes.
5.11.4 Records
The organization shall maintain records of MOC (see 4.5).
Hope it helps you.
 

Mikey324

Quite Involved in Discussions
#7
Our process is set up in a spreadsheet. It may not work for all, or anyone other than me, but it helps us follow the same flow and not forget anything.

We record:

What is the identified change
What process(es) is impacted
Who are the interested parties that will be impacted
Change duration (temp or permanent)
Root Cause or reason
risk assessment and risk description
Need for PFMEA Update / Risk Assessment Update?
The action to be taken
(the following are all yes/no drop box selections)
Deviation Request or Quality alert needed?
Management System Update/Modification?
Org Structure Change?
Legal/Other Requirement Updates?
New equipment added?
New tooling added?
Contingency plan update?
Required to notify customer? New PPAP?
Responsible Person/Function
Open Date
Implemented Date
Approved by/Verified By
Comments
 

Tagin

Trusted Information Resource
#8
I would start with the relevant standard as the framework for MOC. If they do not have a QMS standard, then I'd use 9001 clauses 4-10 as the skeleton, and expand into the sub-clauses as it is relevant. E.g.,
  • Does this change affect (clause 4)
    • Interested parties?
    • Scope of the QMS?
    • etc.
  • Does this change affect (clause 5)
    • The quality policy?
    • Mission/vision statement?
    • Leadership involvement?
    • Organizational structure and roles?
    • etc.
  • and so on...
Obviously if something is not relevant, then no need to include it (e.g., if they don't do design then no need to include 8.3). Phrase it in their jargon, drill down where needed and critical, and streamline to single high-level questions where low-risk/low-impact.
 

Kronos147

Trusted Information Resource
#9
How does the organization currently manage change? Do they have a document control system with a document change policy\practices? Do they have management review meetings that result in action items? Do they manage corrective actions?

Yes?

Seems like they already have a good start to having a system, they may need to remind themselves to use the tools they have.
 
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