How to start with QMS implementation for startups

[Sowmya G]

Hi, I need guidance in setting up the Quality dept and QMS system for a biotech startup where I am the only subject matter expert (I have only 5 yrs of experience working with QA/QC dept). I need to start implementing and standardizing the process from a broader category (as requested by management).
I am wondering what this broader category or strategy to implement!!! Kindly help me understand this term and how to start.

P.s. I have already started implementing control of documents and records. Created SOP templates for ppl to start preparing SOP. Gave Quality policy and objective templates for management. also working on creating SOP and processes for QA/QMS ISO 9001 required documents.
I don't know how or what else i should start with other than this. kindly help

TIA

 

[gakiss2]

I would start with defining the major processes of the business especially those that are impacted by the QMS. I feel this is a better approach than starting with the procedures required by ISO. Later you will double check that all the required processes were covered but it is very likely they will be. One good way to start defining processes is to make a process map. The 'Process Turtle' used in auditing is a good tool to guide you in building process maps. After the major processes are mapped then you can step back to the 30,00 ft. level and make a process map showing how they all fit together. I could be wrong but this may be what your management means by 'from a broader category'.
Procedures are typically easier to write after the process mapping is done. In fact, some use that process map as their procedure. The turtle diagrams also help to make sure you cover all that is needed for an effective procedure.

Good Luck

 

[Kurt Smith]

Double check what certification standards are going to be most relevant to your field. ISO 9001 is a safe place to start. But if its biotech you may want to lay the groundwork for some more specialized standards as well. It is always a pain to find out the form or process you've setup doesn't actually tick all the boxes for the certification you are going to need.
Depending on how comfortable you are writing the manual, (and how many other responsibilities you need to juggle) I would seriously look into any local consultants you can find to assist. Building from scratch is a lot more work than maintaining or auditing a QMS.

 

[Sowmya G]

I would start with defining the major processes of the business especially those that are impacted by the QMS. I feel this is a better approach than starting with the procedures required by ISO. Later you will double check that all the required processes were covered but it is very likely they will be. One good way to start defining processes is to make a process map. The 'Process Turtle' used in auditing is a good tool to guide you in building process maps. After the major processes are mapped then you can step back to the 30,00 ft. level and make a process map showing how they all fit together. I could be wrong but this may be what your management means by 'from a broader category'.
Procedures are typically easier to write after the process mapping is done. In fact, some use that process map as their procedure. The turtle diagrams also help to make sure you cover all that is needed for an effective procedure.

Good Luck

Thanks for your insight. Can you pls share any reference docs if you have any.
TIA.

 

[Sowmya G]

Double check what certification standards are going to be most relevant to your field. ISO 9001 is a safe place to start. But if its biotech you may want to lay the groundwork for some more specialized standards as well. It is always a pain to find out the form or process you've setup doesn't actually tick all the boxes for the certification you are going to need.
Depending on how comfortable you are writing the manual, (and how many other responsibilities you need to juggle) I would seriously look into any local consultants you can find to assist. Building from scratch is a lot more work than maintaining or auditing a QMS.

You're right! Im actually waiting for the management to recruit a consultant. I'm finding it difficult to streamline the process as per management's need as even the management doesn't have any awareness on how QMS works they come from research background.

 

[gakiss2]

Here is an example Process Map at 30,000 ft. level.

Are you going for ISO 9001?

 

[Sowmya G]

Here is an example Process Map at 30,000 ft. level.

Are you going for ISO 9001?

Yes, ISO 9001. thanks for the reference.

 

[Ed Panek]

I would create a plan starting with a gap analysis.

1) things you currently do that need low effort to align with QMS

2) things you currently do that could be modified to align with the QMS with some effort

3) things required that you have no evidence for. A grassroots effort.

Present this to your supervisor. Provide an outline for your plan. Point out areas you’ll need cooperation with. Obtain that promise to help. There’s probably areas that require specific expertise to finish.

Set up weekly or bi weekly progress meetings with your supervisor to review progress. Keep pushing. As long as you’re making progress that’s good. There will be setbacks though.

 

[Randy]

Here

 

[Sowmya G]

I would create a plan starting with a gap analysis.

1) things you currently do that need low effort to align with QMS

2) things you currently do that could be modified to align with the QMS with some effort

3) things required that you have no evidence for. A grassroots effort.

Present this to your supervisor. Provide an outline for your plan. Point out areas you’ll need cooperation with. Obtain that promise to help. There’s probably areas that require specific expertise to finish.

Set up weekly or bi weekly progress meetings with your supervisor to review progress. Keep pushing. As long as you’re making progress that’s good. There will be setbacks though.

Thanks your suggestion.