Develop scalable, sustainable processes

[Robbie38]

I am pretty new to a small company, hired as Quality Coordinator. They have been certified 9001 for a few years, and I am here to maintain it and look for improvements.

I have no formal education in Quality Management, in fact I knew nothing about QM at a previous company, where I was a production manager, and asked if I was willing to wear a different hat: establish 13485 all on my own, without a consultant. We had absolutely no quality system in place.

So I went to Net to find out what to do, and it didn't take long to realize that the Cove was by far the best resource. I spent hundreds of hours in here soaking up the Legacy content, reading threads, and asking questions. (It was under a different username, it was a long time ago and I forgot my credentials).

It took me about a year, and I got us certified, and maintained it for 7 years. I am so grateful to the Cove, it was my University.

Sorry for rambling, I just didn't want to jump in and ask a question on my 1st post without a little background and saying thanks.

My question: I was given a task: By this Monday, I am to create a bulleted list to give high level details about a goal they have given me: "Develop scalable, sustainable processes to meet future product demands". They want me to think of answering the question "How will we know when this goal has been accomplished?"

I'm somewhat mortified and don't know where to begin.
Since our processes are already in place, they are well thought out and have been in use and effective for a long time, I don't feel there is anything to 'develop'. And what really is a scalable, sustainable quality process?

To me, scalable means processes should be flexible so that as the company grows, the process easily evolves with it and guides it without having to overhaul the process? I could be way off.

As far as sustainability, I'm thinking that perhaps if you have positive collaborations between staff workers to reduce bottlenecks and encourage open communications to make improvements... this can be one good way to achieve sustainability of quality. Any other ideas are very much appreciated!

 

[Alan_DB]

"Develop scalable, sustainable processes to meet future product demands". They want me to think of answering the question "How will we know when this goal has been accomplished?"

Yikes, I hate somewhat cryptic assignments like this. On the other hand, it gets the creative juices flowing.

I am presuming that they are wanting you to focus on quality / QMS processes and how these scale up in comparison to where you are now?

What is the structure of the Quality Department now, do you have a team under you or is it just yourself? How does the Quality department integrate with production and other business units? Easy to see if its just you then you would be swamped if e.g. production volumes doubled. If you give a little more context to your situation I might be able to give some pointers.

 

[Robbie38]

Yep, it's just me, no team. I own the quality program.

>>> focus on quality / QMS processes and how
>>> these scale up in comparison to where you are now?
I think this is a good guess at what they want. I am just going to ask for a clarification today, but I just wanted to ask here first, and hopefully get some real, practical examples.

>>> How does the Quality department integrate
>>> with production and other business units?
In production, I collect product samples for testing and analysis, verify inspections, etc.
If general with engineering and production, I plan and carry out internal audits, look for improvements to processes,
and verify we are doing what we say. I don't think this really answers your question of how Quality dept integrates,
I'm not sure what that means.

 

[RoxaneB]

I curious to hear what comes out of the follow-up for clarification.

My own take on the question was focused more on how can the QMS help us grow and, perhaps, become less of a distinct QMS, but rather more of a BMS and part of the organizational culture. For example:

• Lean and agile methodology potential
• Using historical analysis to enable short- and long-term forecasts in terms of products, volumes, and resourcing needs
• Operational and financial strategic planning supports

 

[John Predmore]

In a previous quote, I wrote

I explain a QMS by focusing on the meaning of the three words. Quality may be measured differently in different industries, but a common meaning of Quality involves fulfillment of requirements and customer satisfaction. The word Management tells us Quality does not simply happen by itself, Quality requires planning, coordinated effort. rules to follow, monitoring, correction. The word System describes interconnected parts which work together to meet some objective, which monitors itself, corrects its own deficiencies, and improves over time.

I think that last sentence is the answer how a QMS provides a scalable, sustainable system that monitors, corrects and improves itself. The only part I didn't mention is to continually review the organizational context (section 4), so growth and direction are relevant with strategic imperatives in a changing world. Plan-Do-Check-Act is how we do that Quality Cycle. If you excel at Continuous Improvement, you eventually have excellent success.

 

[Sidney Vianna]

As far as sustainability, I'm thinking that perhaps if you have positive collaborations between staff workers to reduce bottlenecks and encourage open communications to make improvements... this can be one good way to achieve sustainability of quality. Any other ideas are very much appreciated!

ISO 9004:2018 gives guidelines for enhancing an organization's ability to achieve sustained success. This guidance is consistent with the quality management principles given in ISO 9000:2015.
ISO 9004:2018 provides a self-assessment tool to review the extent to which the organization has adopted the concepts in this document.

 

[Robbie38]

Thank you Sidney, John, & Roxane! Your feedback is very helpful! I'm putting in a purchase request for ISO 9004:2018

 

[Ed Panek]

Future product demands?" That could be a completely different product using different suppliers and customers and technology. You can do that for some parts of ISO like complaints and receiving/shipping processes.

However to ask to future proof your QMS?

The question is very broad so only a very broad answer can be developed.

Also stop thinking about quality like some ultimate goal. Its not something to be finally wrapped up like painting your house.

 

[Big Jim]

What a challenge. I'm not sure that it can be answered in the context of a quality management system. I suspect that even an MBA degree would provide the foundation for that. More likely it would take a team with not only QMS knowledge and a business degree, you would need people with engineering and manufacturing education and experience.

Good luck.