ISO Clause 4.1/4.2 & 6.1

[malasuerte]

The risk assessment and analysis was completed utilizing incoming Company B's format. Since both businesses are relatively small, I am likely going to be managing both quality systems.

Those employees with Company B & its QMS will stay the same. So, my question is would any training have to be completed under Company A's QMS?

Sorry......but you stated that a risk assessment and analysis was completed, then you ask if training is required for Company A??? It sounds like the risk assessment/analysis was not complete.

If you did a complete RA, you should know if some sort of training is required regardless of the QMS. Simple example: is anyone in Company A going to be involved in any activity of Company B? Then Company A people need training.

Is there now an overall 'building' (since you're both in the same building) approach to something required?

In addition, part of a QMS is continual improvement; aren't there places where Company B has something that enhances Company A? (or vice versa)

This is an 'on-the-surface' opinion based on your posts - but as Amit says, a single QMS would be much better. When this project began, I personally would have sought to have a single QMS for the whole organization. Then you would complete a thorough assessment and understand where all the differences are and plan to merge the QMS. It feels like you may run into issues if you try to maintain both. But maybe not....w/o knowign the full picture, who knows.

 

[qualprod]

Our company has a separate spreadsheet for 4.1/4.2 regarding the organization's context with the needs/expectations, risks, opportunities and actions of ext. and int. issues and interested parties.

We also have a process risk assessment matrix (addresses 6.1 but listed under Clause 4 in our QMS) that addresses risks like product quality, OTD, resources, CoQ, etc. when evaluating each of our QMS Processes (Sales, Purchasing, Production) & Support Functions (QMS Planning, Monitoring, Improvement). It was created in a way that makes it difficult to understand rather than using an SEP matrix.

With our parent company moving into our facility, many of their customers have asked me to provide a risk analysis of the move. Since we are not AS9100 certified, our risk analysis is not a documented process. A company relocation risk analysis is new to me so I'm not 100% sure what I can/should use to accomplish the requested task.

1) I would use the Org. Profile (as mentioned above) to address the risk & opportunities along with their actions.
2) However, am I obligated to use the Process Risk Assessment Matrix we have even though the scope of its use is outside of it?
- Could I deviate and use an SEP matrix or should I just reword the existing Matrix?

Hi, ASdriven
take a look at this:
You can kill two birds with one bullet... Planning and risk considerations.

From TS 9002 9002
6.3 Planning of changes
The intent of this subclause is to determine the need for changes to the organization’s quality management system in order to adapt to changes in its business environment, as well as to ensure that any proposed changes are planned, introduced and implemented in a controlled manner.
Properly planning a change can help to avoid negative consequences such as rework, or cancellation or postponement of a service; it can also result in positive consequences such as the reduction of nonconforming outputs, or reduced incidents of human error. The purpose of planning the change is to maintain the integrity of the quality management system and the organization’s ability to continue to provide conforming products and services during the change. The organization should consider actions that could reduce the potential for negative impacts of the change, such as first conducting a trial of the change before full implementation, or determining actions to be taken when the change is not successfully implemented.
The application of risk-based thinking can be helpful in determining the actions necessary in planning changes to the quality management system. The organization should consider the availability of resources and necessary allocation or reallocation of responsibilities for any change. This could be done by assigning persons to a team to manage the change, or by delaying the change until the right resources are available.
The need for a change to the quality management system can be determined in many different ways, for example as part of management review, from audit results, reviews of nonconformities, complaints analysis, analysis of process performance, changes in context or from the changing needs of customers and other relevant interested parties.
The need for changes can result from, for example, the transfer of production lines from one site to another, changing process methods to improve trends in non-conforming outputs, using new information and communication technology (ICT) for a service or process, outsourcing important processes, persons in key roles leaving (either due to retirement or medical issues), or moving to online order handling.
The impact of such changes on the quality management system should be evaluated by the organization and the necessary actions taken to prevent undesired effects. This can range from the application of project management approaches to establishing performance and validation testing of new processes.

Hope it helps

 

[Johnnymo62]

I assume from your original post that your parent company is AS9100 registered. If so, are they planning to be AS9100 registered at your location?

 

[ASDriven]

@AMIT BALLAL @malasuerte @Johnnymo62 @qualprod - Thank you all for your suggestions and comments! Neither of us are AS9100 registered. The company and operation structure are staying the same with only the location changing due to building lease expiration. In reviewing both QMSs, there are a number of overlapping processes but Company B's will need to be revised once the new workflow is finalized in our Q3 management meeting. There are indications of a M&A but those discussions have not heated up. The RA highlighted potential resource, product quality and OTD risks and their mitigation strategies. Yes, the goal will be to merge the QMS of both companies together but no decision has been made as to if it will be a down or up stream merger.

I'm doing what I can as the only QM to improve our current QMS while dealing with any RMAs, NCs, CARs, Reach/Rohs, management reviews, internal audits, gage management, etc. now also having to deal with company B's quality system. We've been looking for personnel resources since November 2020.