ISO 9001:2015 6.2 - Planning Changes

rogerpenna

Involved In Discussions
#1
So... I am quite in doubt of WHEN we should plan and document changes to the extent of ISO 9001:2015.

It seems like a whole lot of extra bureaucracy, if used for everything.

Should I fill a whole Change Form, identifying risks, responsabilities, etc, etc, just to change the flow of a process?


Proposed Change: Employees must first pour the coffee and then the sugar.

Problem Identified: When sugar is poured first in the cup, and then the coffee, the sugar melts and forms a crust on the bottom of the glass, which the cleaning lady needs more time to scrub it clean

Risks: Employees may not be able to sugar their coffee to their liking, leading to widespread revolt and strikes

Opportunity: Reduction of sugar levels on company employees (some might give up on coffee and drink tap water, reducing coffee costs to company)

Measurement Criteria: Cleaning Lady will measure number of cups she scrubs and average time, for 1 month. After enforcing the new rule, we will try to reduce total time spent scrubing cups by 75%


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Jokes aside, I've seen people talking about all this change planning for stuff like hiring a new employee...

So, when should I apply it? And how? In a new form that will be filled when someone decides to change the position of their desk?


Or should it be integrated into everything else? As it somewhat already is?


Because it seems to me, everytime a Non Conformity is identified, it's analysis and action plan with 5W2H, it already covers all of that.

We work with Infrastructure Civil Engineering. Our main process is in the worksite itself, and it is not highly standardized. Each project is a different project. Of course, you can´t first pour the asphalt, then compact it, then lay the gravel base, and then excavate the earthworks. But it mostly is totally the opposite of a production line.



That said, there are project changes. Again, those are mostly covered in other documents, like the Worksite Quality Plan (which is an old requirement of another standard).


We then have action plans created based on the Risk Identification and Treatment procedures. Again, those action plans I guess cover most of the "requirement changes".


Some other changes may appear based on Critical Management Review. I supposed creating a new Action Plan (without starting FROM a risk accessment or Non Conformity) would also cover that when it comes to change, right?


What is left out? Not many things I guess.

Maybe a procedure describing how and when we deal with changes, basically refering to Audits and Non Conformities and resulting Action Plans, to our Risk Accessment and Treatment procedure, to changes coming from the Management Critical Review, etc... a master Change Planning document refering to other documents who already have procedures in place regarding changes?
 

qualprod

Trusted Information Resource
Trusted
#2
Take a look at TS 9002, You Will find a crear explanation of this.
It easy to Understand.
But it refers to changes which really need planning, but not all changes.this practice it allows you to plan changes avoiding problems.
Hope this helps



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AMIT BALLAL

Quite Involved in Discussions
#3
"6.3 planning of changes" is the clause.
This relates to managing changes related to quality management system. If you are changing how the process works, or input / output, or interaction /sequence of the process, then this clause applies.

8.5.6 relates to change management related to production and service provision. If you are changing the production /service functioning i.e. not as per the developed process (as per 8.3), then this clause applies.

How do you manage change is up-to your organization. Make sure the changes are managed properly so that there are no adverse effects. Make sure people are aware of what is a system, what's their part in system, how their work relates to other processes, what is ultimate outcome of system and how improved performance affects them (7.3 - c). This creates basic ground, so that they can know how changes to QMS affects them and what needs to be done in order to manage changes.

Same thing about changes related to production and service provision. You can define here which changes needs to managed, and if required, create a form to make sure change management is carried out in proper manner.

Basic purpose of these requirements related to change management is to prevent adverse effects and to balance system. You can just make people aware and during internal audit, check whether there are any changes done and are managed effectively. Additionally such changes will be reviewed during management review.
 
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