I've inherited a mess - New to the Regulatory/Quality area - ISO 13485

R

Rhino

Well, I am new to the Regulatory/Quality area. I have a legal and project management background and was recently choosen to run the Regulatory Affairs division of our company.

Needless to say, I inherited a mess. We are in the process of going from 13485 1996 to 2003. And the manual, procedures and processes are all a complete mess and rather outdated to say the least.

I have a pretty thourough understanding of 13485 2003 and I am still trying to thouroughly learn our current practices, but I do have a basic understanding of how things are set-up.

What is the best way to start this whole process? Any advice and any recommendations that you all have would be greatly appreciated. I have learned alot already reading through the posts, but there is an awfull lot of info to digest.

Thanks for your help.

Ryan
 

DannyK

Trusted Information Resource
Approach to situation

Ryan,

I would start off with an internal audit to the old standard to highlight the problems and issue corrective action requests for system problems.

I would ensure that all the process owners deal with their problems and would follow-up on a regular basis.

Next I would modify the current documentation to include the new requirements and would invite management and supervisors to a training session highlighting the differences.

A schedule with all the gaps should be created and a weekly follow-up shouldbe performed. Then perform an audit on the differences or on the whole system.

Danny
 
Q

qualitygoddess - 2010

Ryan:

Welcome! Try doing a couple of searches on 13485. There is a nice cross-reference tool that someone posted here about 6 months ago that shows the 13485:2003 requirements along with 9001:2000. I found it most useful! If no one else posts it, I will dig it up at home and send it along.

I think the first thing to do is go through 13485:2003 and compare its specific requirements against your current Quality Manual (QM). Remember to note "not applicable" requirements right in your QM.

You might also want to look through previous internal audits and registrar audits to see what kinds of issues have been present. Then dig into the complaints, and make sure everything has been answered and verified.

Then it is probably time for you to plan and carry out an audit. Once you know the gaps, you will be able to define the path to compliance!
 
A

Aaron Lupo

Rhino said:
Well, I am new to the Regulatory/Quality area. I have a legal and project management background and was recently choosen to run the Regulatory Affairs division of our company.

Needless to say, I inherited a mess. We are in the process of going from 13485 1996 to 2003. And the manual, procedures and processes are all a complete mess and rather outdated to say the least.

I have a pretty thourough understanding of 13485 2003 and I am still trying to thouroughly learn our current practices, but I do have a basic understanding of how things are set-up.

What is the best way to start this whole process? Any advice and any recommendations that you all have would be greatly appreciated. I have learned alot already reading through the posts, but there is an awfull lot of info to digest.

Thanks for your help.

Ryan

The whole process as in moving from 13485:96 to 13485:03?
What is time frame Mgmt wants this completed by. Then I would:
If that is the question, I would start with a gap analysis of your system see what if any systems you are missing, from there I would create a checklist of items you needed to complete, call a cross functional team together (QA, regulatory, Operations, etc..) assign responsibilities. After the tasks have been completed I would audit the system again and see if your corrections have been implemented.
 
R

Rhino

I re-wrote our internal audit process back in December when I first started doing some work in the department and we have gotten some really good feedback and results from the audits that have already taken place. We are currently about halfway through the entire system. There have been quite a few corrective actions already written.

The largest problem I am encountering is that the current system is written such that each procedure of the system is a bad work instruction that references some other better work instructions. The system has been band-aided for way too long and no-one has seemed to be in any rush to change.

Thankfully for them I am here and willing to do whatever is necessary to fix the problems. However, I am pretty much to the point of starting the whole system over and creating the new system from the ground up, because there is very little salvageable from the current system.
 

Wes Bucey

Prophet of Profit
Welcome to the Cove:bigwave:
Is the company currently REGISTERED to 13485 or merely "following it?"

I can't imagine a registrar letting an organization get so fouled up and maintaining the registration.

Do you intend to register to 13485-2003? Do you have a registrar selected?

We've used the term "Gap Analysis" - do you really understand what that means? If not, tell us and we'll help you.

Ultimately, conforming to a Standard requires only two big items
  1. Management approval and involvement
  2. Clear understanding of the Standard
Everything else after that is merely putting one foot after the other.

ISO 13485-2003 is one thing. The primary concern should be dealing with FDA (the "regulatory" part of the equation.)

How are you set up to do that? The more information you can give us without us having to drag it out of you, the more "to the point" our responses will be.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Rhino said:
I re-wrote our internal audit process back in December when I first started doing some work in the department and we have gotten some really good feedback and results from the audits that have already taken place. We are currently about halfway through the entire system. There have been quite a few corrective actions already written.

The largest problem I am encountering is that the current system is written such that each procedure of the system is a bad work instruction that references some other better work instructions. The system has been band-aided for way too long and no-one has seemed to be in any rush to change.

Thankfully for them I am here and willing to do whatever is necessary to fix the problems. However, I am pretty much to the point of starting the whole system over and creating the new system from the ground up, because there is very little salvageable from the current system.

Welcome Rhino, :bigwave:

It actually sounds like you are well on the right track. So much so, that you can see the thing feels enormous.

But one thing at a time is all you can do. I'd start with the work procedures, since you say they are antiquated and messed up in general. Would it suit your organization to use scripted flowcharts? Once they get used to them, I think visual people would favor these and probably use them more often than a written piece. Whichever type you use, prioritize with the ones causing the most problems or expense in faulty product or wasted activity. You can get trusted people to help with getting the steps down, and do the actual writing or drawing yourself so everything seems to be talking in one voice.

Of course, while making work procedures you and/or your trusted helper(s) should keep the standard handy and bounce it against what is actually being done, which audits would have found. The work procedures would contain references to prints, standards, manuals and other necessary instructions that direct the basic functions.

Processes show how the work procedures engage with each other to complete the steps in that portion of product or service that they address. These can also be scripted flow charts, which would reference the work procedures but not the prints, standards manuals etc.

The QMS (quality manual) is made to show what is being done in the processes, not what should be done. This is important to ensure the manual "belongs" to the organization and people follow it. Of course, while making the QMS one should keep the standards handy to ensure what is being done is per the standard.

The thicker the QMS manual is, the more there is to keep track of and audit so I would try to keep it skinny. I don't like templates except it's helpful to see an example so one can get an idea of what to say, and how to do it without saying too much or too little.

I strongly feel that you are going to be all right but all this work is going to take awhile.

Be well!
 
G

Gerry Quinn

Rhino,
I would get a copy of ISO 9000:2000 and follow the process defined in 2.3. It sounds to me like you should start from scratch.
The process for implementing a quality system that is laid out in this document is at 50,000 feet and forms a good frame for drilling down to more specifice activities.
It gets you back to the root reason for the existance of your organization. "The needs and interests of the Interested Parties". When you have determined who they are and what they want then you can develop a "Quality" policy and "Quality" objectives. Then processes etc can be defined and documented as required.
Of course all of this will ASSUME that you have the total and undivided support of " Top Management". All kidding aside, you must get this or you are cooked. So make sure that you get a clear understanding of what they want. Sometimes its only the certificate.

Gerry
 
R

Rhino

Thank you everyone for your help and ideas. Let me give a little more in depth breakdown of what we currently have and my thoughts on improving it. Please feel free to critique my ideas all you want. I need some healthy objective view points.

Our company designs, manufactures and sells medical devices. We are currently registered to 13485 1996. We had our audit back in Ocotober of 2004 and are scheduled for another in June I believe. We are growing company with currently just under 50 employees, but forsee a rather substantial growth phase in the next 2-3 years which will at least double the size of the company in personnel.

The current system was creataed about 8 years ago I believe and has worked, but is just very cumbersome. It does work with 13485 1996, but it is not the most streamlined system out there.

After reading some more and going to a couple of seminars, I have gained a better understanding of how our current system relates with 13485 1996 and 2003.

We have a Quality Manual Document which outlines very basically what is required by the 13485 1996, but it also contains alot of information about other areas of the company as well. It is more like a business manual than a quality manual I guess you could say. It is about 20 pages long. We also have what we call procedures which are basically the requirements of 13485 and some other company procedures that are laid out more like incomplete work instructions which also reference other documents we call work instructions. Our Quality Manual (business manual) and our Procedures make-up what should effectively be called the Quality Manual as whole. So, this document is more like 100 pages. It is fairly large when it is put together.

The way I am viewing things now is that the Quality Manual should just be the basics saying that you are compliant with 13485. I need a little clarification as to how much information this should entail. Should it just be a flow-chart or an organizational chart. I guess is the basically just a visual or I suppose a written document that shows the process flow of a product through the company, from conception?

What we are calling procedures and work instructions are actually SOP's if I am not mistaken. Clarify me if I am wrong here. There should remain as such, but be written so that we have just one type of document rather than having procedures and work instructions both.

Now, is it enough to have a simple reference line in the Quality Manual that references the appropriate work instruction/procedure which actually tells how something is done. For example, the Quality Manual will mention that we we have a CAPA system and it will mention how a CAPA is determined and then it will reference the Work Instruction/Procedure which will actually explain how the CAPA system works.

Should there be a written Quality Manual and a Process flowchart or are they basically one in the same?

I hope this clarifies my problems a little better for everyone to understand. I may not have worded everything correctly and I may have missed a few things.

Please ask me questions and give me advice and anything else. I want to know if my basic thinking is correct on this.
 
G

Gerry Quinn

Rhino,
13485:2003 requires in 4.2.2 that you establish and maintain a quality manual. It also tells you what that manual must include.
Typically, one would write a manual that addresses all of the relevant portions of the standard. The format would be the same as the standard. This makes it easier for others (auditors) to evaluate your system.
In the manual you would state how your organization intends to address each requirement.
You must also link your manual to your procedures by either including the procedures in the manual or making a reference to them.
You can use flow charts, diagrams, written statements, etc. as long as it makes sense and addresses the requirements of the standard.

Gerry
 
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