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Section 8.5.6

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Guest user Created:   Dec 02, 2020 Last commented:   Dec 29, 2020

Section 8.5.6

Referred to section 8.5.6 (control of change) we are planning to implement " management of change procedure". we plan to use this procedure for all changes in IMS (for changes in procedures, company specification or aspects). We will do risk analysis to identify potential hazards and impacts associated with the changes. All discussed with the staff in conjunction with the change send to QA department for registration 
is it possible to use this section for these purposes and am I correctly understand section 8.5.6?

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Carlos Pereira da Cruz Dec 02, 2020

The purpose of clause 8.5.6 is different from what you mention. Remember, clause 8.5 is about production of a product or provision of a service. So, this clause is about changes, temporary changes made during production of a product or provision of a service.

For example, because of the disruption in the supply of a raw material during the covid 19 lockdown period, a company decides to use an alternative raw material that is not part of the standard recipe. Another example, the recommended equipment to manufacture a product is not operational. To avoid a delivery delay, a company decide to use an alternative equipment. A last example, installation of a product is made by an experienced employee, due to an unplanned emergency service, the installation is going to be done by a less experience employee.

Organizations should review these changes and monitor them to ensure that despite the abnormal situation, products and services are within specifications.

You can find more information below:

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Rashid Dec 29, 2020

Dear Carlos Pereira da Cruz,

As understand section 8.5.6 (control of change) strictly refer to changes in servises (projects).

Is it any section in standard to use MOC procedure  besides project to all temporary  and permanent changes  in  organizational, operational,  personnel, systems,  IMS procedures, modifications on equipments, legal, materials ?

As knows, every changes in company shall be evaluated (risk or hazards) before changes.

 

 

 

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Carlos Pereira da Cruz Dec 29, 2020

There is no explicit requirement in the standard to use such a procedure. However, as you rightly mention, any changes may bring risks and opportunities. A good practice is to determine and evaluate them in order to act when needed. For example, I’m working with a manufacturing company that determined the risk, the possibility of having to use employees to perform unusual tasks to replace colleagues on sick leave with covid. For this reason, they prepared an on-the-job training plan for eventual substitutes. Another example, when organizations update procedures it is a good practice to inform and or train people about the changes.

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Dec 02, 2020

Dec 29, 2020