Looking to Impress - New Job - Advice, Thoughts, Comments Welcome

NikkiQSM

Quite Involved in Discussions
#1
I have recently taken on a part time position of Quality Manager at a small company that builds metal medical trays. The trays are held together with brackets and are used to contain medical tools for hospitals.

The trays are FDA approved, but the company is not ISO certified. The owner would like to be ISO 13485 certified by the beginning of the year, to get additional business.

From what I see, major organization is needed. They are a small company - 10 or so employees tops. The owner has been doing all the major ISO related work, but has not kept up on it.

The company outsources almost everything! They provide specs for the metal parts to be cut, and then the parts arrive and they put them together, and ship them out. That's it.

There is a lacking of documentation to say the least. When an order is prepared, all the parts are put on a movable cart. Nothing really stops someone from walking by and just grabbing one of the many pieces. The carts are identified with a single lot number. Nothing more.

I think my biggest hurdle will be getting everyone to follow the process, as everyone just does what they do.

They haven't done an internal audit in 2 years.

How would you approach this challenge? What would you focus on first? Any comments are appreciated.
 
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Johnny Quality

Quite Involved in Discussions
#2
That's quite the challenge you have!

I'd sit back and watch how the business functions and see how it matches to their documented procedures (if they have some). Try to listen and shush for a while and let everyone else talk.

Though you mention the owner would like be ISO 13485 certified by the end of the year? I'm ignorant on ISO 13485 but is four months enough time? I'd find out what's involved and see what the actual time frame is.

Finally, what were you hired for? Did the owner mention what they would like you to? That's another good starting point.

Best of luck!
 

NikkiQSM

Quite Involved in Discussions
#3
Thanks, Johnny. I already am currently a Quality System Manager for a medical compounder. I've been with the company for 15 years. I am very familiar with ISO 9001 and ISO 13485. I set up the company and got both certifications.

While I am still with that company, I took this part time job as a Quality Manager to help certify the company to the 13485 standard. I explained to the owner that once I have had a chance to see how their process works, I can give her a realistic time frame for certification.
 

Golfman25

Trusted Information Resource
#4
Document what they do and work from there. Do not start creating procedures, based on your past experiences, for them to follow. It won't work. If there are gaps, sit down and address the gaps. You're looking for the easiest way to improve or comply. Keep it simple and don't add a bunch of extraneous stuff.
 

Tagin

Trusted Information Resource
#5
While I am still with that company, I took this part time job as a Quality Manager to help certify the company to the 13485 standard. I explained to the owner that once I have had a chance to see how their process works, I can give her a realistic time frame for certification.
Once your QMS is setup and in place, you will need several months to accumulate data and records for the auditors to certify the system. So, beginning of next year (4 mo from now) as a target seems impractical at best.

I think my biggest hurdle will be getting everyone to follow the process, as everyone just does what they do.
If this is so, then this needs to be addressed by top mgmt. They need to proactively reinforce the need for everyone to follow procedures and policies. It is both the benefit and the bane of a very small company to tend to have an informal culture.
 

NikkiQSM

Quite Involved in Discussions
#6
The company currently has documents, and procedures. It's just no one fills out the documents, and whether or not the process follows the documented procedure - I doubt highly.

I wont be creating too much of anything rather than cleaning it up and updating to what is actually being done.
 

atitheya

Quite Involved in Discussions
#7
Sometimes it is more than what meets the eye.

Have you done a gap analysis? Setting up a company with the standard, and applying the standard in an already existing company are different scenarios. As Johnny Quality says, observe for some time. You may find that a lot of work is being done. May be some of the already documented procedures need a revision to suit the company. At other instances you need to fill the gaps.

Note down the gaps. Educate the top management on the necessity to plug those gaps and the time assessment. Four months is too short a time but it really depends on the status when you do the gap analysis.

Once the top management is in agreement with you, familiarize others in the company with the standard. Involve them, all of them, in development/revision of procedures and other documentation and implementation planning.

Get the QMS implemented. Conduct internal audits, management reviews and improve the QMS and its effectiveness.
 

yodon

Leader
Super Moderator
#8
In addition to what others have mentioned, one thing you'll want to focus on since they are outsourcing most everything, will be purchasing and in particular, Quality Agreements. In the Quality Agreement, be sure to spell out that they can't change anything (parts, process) without informing you.
 
#9
I have recently taken on a part time position of Quality Manager at a small company that builds metal medical trays. The trays are held together with brackets and are used to contain medical tools for hospitals.

The trays are FDA approved, but the company is not ISO certified. The owner would like to be ISO 13485 certified by the beginning of the year, to get additional business.

From what I see, major organization is needed. They are a small company - 10 or so employees tops. The owner has been doing all the major ISO related work, but has not kept up on it.

The company outsources almost everything! They provide specs for the metal parts to be cut, and then the parts arrive and they put them together, and ship them out. That's it.

There is a lacking of documentation to say the least. When an order is prepared, all the parts are put on a movable cart. Nothing really stops someone from walking by and just grabbing one of the many pieces. The carts are identified with a single lot number. Nothing more.

I think my biggest hurdle will be getting everyone to follow the process, as everyone just does what they do.

They haven't done an internal audit in 2 years.

How would you approach this challenge? What would you focus on first? Any comments are appreciated.
Great responses so far. Yes its definitely challenging but not an impossible task. Best luck!
 

monoj mon

Trusted Information Resource
#10
I wont be creating too much of anything rather than cleaning it up and updating to what is actually being done.
This would be the best practice for now. Creating too much new procedures may disrupt the work flow, but rather filter out the information that you want to share with them in order to fill the gap just enough to get them certified this time. After that you can suggest the organization plan you have for their next audits. It usually takes time for someone to get adopted with a new system. As a starter, I would suggest to pursue the owner/top management about your new plan for the next audits. Once s(he) is ready to adopt, the rest of the team will automatically follow.
The company currently has documents, and procedures. It's just no one fills out the documents, and whether or not the process follows the documented procedure - I doubt highly
Regarding filling out the documents/following the procedures, make these documents easily accessible to each and everyone (if not confidential). As a general practice, in my company, we hang the forms in folders (or keep a computer/tablet if it is an online form) at every section where it is needed and have assigned someone to keep/collect the records everyday. Same goes with the procedures, we keep the copies at many places for everyone's easy access so that whenever in doubt one can quickly have a look at it. If it is a flowchart, we make a big poster of it and hang it for everyone's visibility.
 
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