QA Manager Responsibilities

Hi,

I am pretty new here and first time posting.
I have been trying to streamline few processes at my work and need some suggestions from all of you.
Its a very small IVD Reagents/Buffer/Antibodies manufacturer. I am the one person QA team here.

I review the Bulk Mfg. Batch Records once QC approves it for shipping but Shipping department also want me to approve each and every sales order that comes in. Basically, they want QA review on all the products thats being shipped out.

In my honest opinion, as long QA is involved in Bulk Mfg. Review and have approved the lot already, QA doesn't need to be involved what's on Sales order and review customer's name, address, PO# and quantity being shipped. I suggested that we can have another person within Shipping verify these information other than the person packing.

Am I wrong? Let me know what you think?

Really appreciate your help.
Thanks

QA Bee

Re: QA Manager Responsibilities?

Common quandry. Small company, things need to get done (or don't need to ) and somebody has to do it.

Nobody wants to, so it gets handed to the QA person.

Food for thought - why does somebody want this done? Has there been errors that they're hoping to prevent? Is it something that somebody else was doing that they hope to get out of? Is there a good reason why they want QA involved?

Don't dodge things you really should be involved in but don't volunteer for things you shouldn't be involved in - the more you take on the less you'll be able to accomplish.

That said, if it's a small company, there may be no alternative - everybody wears multiple hats. Is this a problem that needs fixing by changing the process, or just a division of labor?

Re: QA Manager Responsibilities?

I think it was implemented long time back because there was only one shipping person and no other employee to verify one's work.
Also, There is so much to do specially me being all alone here and I can't be spending time looking at Sales orders. I already have my hands full with DHF files (we have 500 plus products), Mfg. Records, Training, Documentation, PM, Audits, Complaints, NCR, CAPA etc.

Re: QA Manager Responsibilities?

QA Bee said:

Hi,

I am pretty new here and first time posting.
I have been trying to streamline few processes at my work and need some suggestions from all of you.
Its a very small IVD Reagents/Buffer/Antibodies manufacturer. I am the one person QA team here.

I review the Bulk Mfg. Batch Records once QC approves it for shipping but Shipping department also want me to approve each and every sales order that comes in. Basically, they want QA review on all the products thats being shipped out.

In my honest opinion, as long QA is involved in Bulk Mfg. Review and have approved the lot already, QA doesn't need to be involved what's on Sales order and review customer's name, address, PO# and quantity being shipped. I suggested that we can have another person within Shipping verify these information other than the person packing.

Am I wrong? Let me know what you think?

Really appreciate your help.
Thanks

QA Bee

Click to expand...

QA Bee,

Are you also responsible for internal audit? If so you have to be careful not to accept responsibilities that would compromise your independence.

You may not yet be operating a process-based management system where just about every process is owned by someone other than the QA Manager.

For example, the people accepting the orders (Sales?) should be competent to review and verify the feasibility and completeness of incoming orders.

Your colleagues may not understand that QA should be delivered by them using and improving their management system to understand and fulfill requirements. For some reason they see "checking stuff" as your job. I'm sure that checking orders is not the only example they see.

The way out of this is to obtain the authority and commitment from the top manager to develop your process-based management system to help users to get their work right the first time.

John

Re: QA Manager Responsibilities?

Back in the ?Dark Ages? of our company it was considered the job of Quality Control to inspect quality into every aspect of our operation. The number one thought in everyone?s mind was to get QC to approve what they were doing and then they were permanently off the hook ? no matter what. Fortunately Top Management discovered ISO 9000. They began to look at everything as a process and the employees concerned with the process are the owners. Quality Assurance now only monitors the outcome of these processes. Our reject rates now hover around zero and scrap is 10% of what it was 20 years ago. I say this because it sounds like your management (or owner) haven?t grasped the big picture of assuring quality and customer satisfaction. You have a huge sales job ahead of you to get each department to be responsible for their own product or service.

Re: QA Manager Responsibilities?

Whoa, small world.

I work in the exact same line of business.

QA does not review any sales/shipping materials. Once final release of product is complete, our job is done.

The reviews for sales/shipping falls with the Sales department (we have two people who review each other's work) and MFG manager for shipping, since that department resides under the MFG manager.

I hope this helps! Good luck!

Re: QA Manager Responsibilities?

QA Bee,

Would you like a job spec for the modern QA Manager?

John

Re: QA Manager Responsibilities?

QA Bee said:

Hi,

I am pretty new here and first time posting.
I have been trying to streamline few processes at my work and need some suggestions from all of you.
Its a very small IVD Reagents/Buffer/Antibodies manufacturer. I am the one person QA team here.

I review the Bulk Mfg. Batch Records once QC approves it for shipping but Shipping department also want me to approve each and every sales order that comes in. Basically, they want QA review on all the products thats being shipped out.

In my honest opinion, as long QA is involved in Bulk Mfg. Review and have approved the lot already, QA doesn't need to be involved what's on Sales order and review customer's name, address, PO# and quantity being shipped. I suggested that we can have another person within Shipping verify these information other than the person packing.

Am I wrong? Let me know what you think?

Really appreciate your help.
Thanks

QA Bee

Click to expand...

I may be mistaken but I see no place for QA people in inspecting bad product out, or, inspecting good product in. The responsibility for good or bad product lies with the process owner of the production system. Its up to them to work on the system and improve capability to make less bad product.

QA can assist with know how, technical support etc but QA inspection is the responsibility of the process owner.

Re: QA Manager Responsibilities?

Thank You so much for your responses!

I brought this up to upper management and they agreed that QA should not be involved in such things and now its off of my tasks...Yahooo!!

Thanks all for your pointers!

Re: QA Manager Responsibilities?

QA Bee said:

Thank You so much for your responses!

I brought this up to upper management and they agreed that QA should not be involved in such things and now its off of my tasks...Yahooo!!

Thanks all for your pointers!

Click to expand...

QA Bee,

Thanks for the update.

May your successes continue.

John