Need help on QMS Development in an AS9100C certified organization

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Mr. K

So I recently was promoted to the position of quality manager after our organization was hit hard by an audit. We're still an AS9100C certified organization, but our organization has to make some big changes.

As Quality Manager, I've been assigned the responsibility of developing processes and procedures to address deficiencies in our QMS. I was wondering if anyone had some tips and/or resources to assist me in this project. For example, does anyone have specific methodologies or tools for a QMS development life cycle that they'd like to share?

I apologize if this has already been discussed in great detail before. I did a brief search through the forum and didn't find anything.
 

Michael_M

Trusted Information Resource
Re: QMS Development: Tools and Methods

Sounds like you got a bit of work ahead of you. I assume your audit found some non-conformance's, I would start by addressing these properly. Do a good root cause/corrective action and verify the effectiveness of the actions taken. Regardless of major or minor, you will need to address all non-conformance's. The Major's will require a revisit from the auditors (as far as I am aware). Look at all the non-conformance's and see if there is a 'trend' in 'why' you got them. Getting a non-conformance for calibration may be different than getting one for inventory control (different corrective actions) but is there a systemic reason that both of these failed? Is there another place that the systemic reason could have created a non-conformace but did not, I would fix this next?

As a general rule, you have to get top managements buy in (which I assume you have at this time) and you have to work with the process owners to fix and/or address the requirements.

Once you get the triage done, then you may or may not need additional training (internal audits, etc). Remember, you will repeat the audit in a year (or less).

Not knowing your situation, I can only offer the general advice
 
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bussb

Re: QMS Development: Tools and Methods

I will second Michael's advice in first doing an audit of the Quality System using AS9100 as your audit guide. Just Google search "AS9100 audit checklist" or look in the Elsmar file archives for an AS9100 system checklist. Go through the checklist and seek answers from each of your process owners Purchasing Management, Engineering Management, company Owner/Top Management, Manufacturing Management etc.

Once you work through this "gap assessment", you and your process owners will better understand where the deficiencies in your AS9100 system really are. If you are already certified, much of your system is in place, so just work with your fellow managers to agree on what needs improvement and start working on those areas. You will need to seek support from their "boss" or company leadership, agreeing that these improvements are part of their responsibility list.

As part of your assessment, make sure to review any registrar audits or recent customer audits where portions or the entirety of your system may have already been audited.

Mr. K, please reply and provide us some context to your organization. How many employees? Does the scope of your certification include product Design and Development? Do you have defined individual process owners in your org chart (Engineering, Manufacturing, QA, Purchasing, Customer Service, Document Control) or are these roles shared/split?

Brian Buss
CloudQMS.com
 

dsanabria

Quite Involved in Discussions
Re: QMS Development: Tools and Methods

So I recently was promoted to the position of quality manager after our organization was hit hard by an audit. We're still an AS9100C certified organization, but our organization has to make some big changes.

As Quality Manager, I've been assigned the responsibility of developing processes and procedures to address deficiencies in our QMS. I was wondering if anyone had some tips and/or resources to assist me in this project. For example, does anyone have specific methodologies or tools for a QMS development life cycle that they'd like to share?

I apologize if this has already been discussed in great detail before. I did a brief search through the forum and didn't find anything.

Start by walking the process - take a part and follow it's path and follow the documents. This is the first step, then make a flowchart of the process visited and add supporting process (documents, Internal audits...)

Third, take our the OER (the checklist that the auditor gave you - or use the one on AS9101D. Compare your process to the checklist and see what you are missing (Gap analysis).

Start filling in the blanks, get management commitment and involvement, Training and finally, get the team involved - they have ownership - NOT YOU!
 

Kronos147

Trusted Information Resource
Re: QMS Development: Tools and Methods

Start by walking the process - take a part and follow it's path and follow the documents. This is the first step, then make a flowchart of the process visited and add supporting process (documents, Internal audits...)

....get management commitment and involvement...get the team involved - they have ownership - NOT YOU!

Exactly.

Read section 0.2 carefully.

If you define, document, set and measure objectives against, and audit your processes, you will be well on your way to an effective management system.

The better you understand the interaction of processes, you will better identify area of higher concern. Start there, and work your processes. Keep everyone on the same page with Management Review, and emphasis PDCA (Plan, Do, Check, Act).
 

John Broomfield

Leader
Super Moderator
Re: QMS Development: Tools and Methods

So I recently was promoted to the position of quality manager after our organization was hit hard by an audit. We're still an AS9100C certified organization, but our organization has to make some big changes.

As Quality Manager, I've been assigned the responsibility of developing processes and procedures to address deficiencies in our QMS. I was wondering if anyone had some tips and/or resources to assist me in this project. For example, does anyone have specific methodologies or tools for a QMS development life cycle that they'd like to share?

I apologize if this has already been discussed in great detail before. I did a brief search through the forum and didn't find anything.

Mr K,

In developing your organization's process-based management system I understand that this action planning checklist has been successfully used by many organizations and reflects their experience of what to do:

http://www.qmii.com/content/downloads/LE-022.Q QMS Action Planning Checklist.pdf

This checklist has been paraphrased many times by me on the Cove in trying to help people who are faced with having to develop their QMS.

Best wishes,

John
 

DannyK

Trusted Information Resource
Mr. K,

The first step is to address the nonconformities with a detailed root cause and action.
I would encourage you to read AS9101E that is used by the certification body auditor.
For each process that you have defined, create a turtle chart that explains the sequence of the process, inputs, outputs, with what, with whom, how, interactions with other processes and what are the measures of effectiveness for the process.
 
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Mikhail Sudbin

So I recently was promoted to the position of quality manager after our organization was hit hard by an audit. We're still an AS9100C certified organization, but our organization has to make some big changes.
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Mr. K,

According to your post, It seems that you may have a gap between quality management system and business management system in your organisation. There a lot of good points in the discussion thread. However I would rather start with refining your organisation strategy and polices, and how your quality goals fit into them. After refining quality goals you may proceed with gap analysis and root cause analysis. Having irrelevant quality goals makes all your subsequent work a throwaway.
 
M

Mr. K

Re: QMS Development: Tools and Methods

Mr. K, please reply and provide us some context to your organization. How many employees? Does the scope of your certification include product Design and Development? Do you have defined individual process owners in your org chart (Engineering, Manufacturing, QA, Purchasing, Customer Service, Document Control) or are these roles shared/split?

Brian Buss
CloudQMS.com

Our organization is small. We have just about 20 employees. We do not offer any Design and Development services; we are strictly a manufacturer. We do have an organizational chart, and process owners are somewhat defined (it's a bit nebulous), however it's outdated, and doesn't reflect our current state of operations.

I just want to say thank to everyone who has responded. As I am new to the field of quality, I'll be needing as much wisdom as I can get.

All of the non-conformances of our most recent audit have been addressed and approved by the registrar. However, we were a bit shaken by the audit and as such are attempting to ensure that it doesn't happen again.

For the past couple months I have been analyzing our business operations, creating turtle diagrams and flowcharts, and comparing them to the AS9100 requirements. We obviously have some aspects of our current QMS that work, but we're missing a lot.

The challenge set before me is in developing a more robust QMS whilst integrating our currently effective operations.

I created a little diagram for the development cycle that goes as follows.

Define requirements ---> (Write procedures <---> Refine Procedures) ---> Audit ---> Repeat at beginning.

Any opinions? Criticisms? Advice?

And thanks again to everyone who has responded.
 

DannyK

Trusted Information Resource
Re: QMS Development: Tools and Methods

It sounds like you are on the right track.
I would concentrate first on customer issues and complaints.
Are you meeting your customer requirements for OTD and quality?
 
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