How do you Create SOPs for Multiple Authorities?

Jen C

Involved In Discussions
#1
Hello all,

I am working on updating my company's SOPs for event reporting and recalls. We deal mostly with the EU, but also with the US and Canada. I'm just curious about how other companies write these kinds of cross-authority SOPs. Do you write separate SOPs for each jurisdiction, or just one to cover all? And if the latter, do you treat each authority as a separate case, or attempt to come up with one overall process that applies to all jurisdictions?

Thanks for your feedback!
Jen
 
Elsmar Forum Sponsor

insect warfare

QA=Question Authority
Trusted Information Resource
#2
Re: Creating SOPs for multiple authorities - how do you do it?

Seems to me the most practical application is to document all the common aspects that apply to all authorities, and then start outlining the things that are specific to each authority, and hammer them out on paper. In the end, you should have a single working document with little to no duplication. My piece of advice to you would be not to get wrapped around the axle or "analysis-paralysis" could set in. And make sure it is consistent with your other documentation.

Keep it as simple as possible, but no simpler than that...

Brian :rolleyes:
 

sagai

Quite Involved in Discussions
#4
The most simple way to do so is to define a decision point from the process prospective and to provide the links to the corresponding web pages of the authorities.
 
K

kgott

#5
Hello all,

I am working on updating my company's SOPs for event reporting and recalls. We deal mostly with the EU, but also with the US and Canada. I'm just curious about how other companies write these kinds of cross-authority SOPs. Do you write separate SOPs for each jurisdiction, or just one to cover all? And if the latter, do you treat each authority as a separate case, or attempt to come up with one overall process that applies to all jurisdictions?

Thanks for your feedback!
Jen
Sometimes they just have to be done.

We have clients who demand that in addition to legislative requirements, we also need to address all the requirements of OHSAS 18001 and AS4801 (Australian safety std) and the clients internal requirements at the same time. This causes us to have to address issues and make statements in our processes, that just do not apply to our work but we have to get a certain 'score' to be certain 'category' of supplier. We do this just to accommodate the requirements for a few international iconic mining and O&G clients.

It's a juggling act but by careful wording, one can navigate through the maze. I have found the key can lie in being somewhat 'generalistic' in the description of how the process works or on how we meet their standard.

Bear in mind too that SOPs when approved by clients, are subject to change as a result of changes in the way work is done and continuous improvement occurs.

Sometimes these are mere 'tick-the-box' exercises but sometimes auditors come to visit. We will be visited in October so that will be an interesting time for me.
 

tehuff

Involved In Discussions
#6
I have done it both ways (all-in-one or separate) and both methods have their merits. The front-end process at a general level is the same for all countries so put this in an SOP and then either a) create separate country-specific sections in this same document or b) point to separate country-specific SOPs. Either way, make it transparent so it is easy to explain to an auditor. I agree with Insect Warfare, don't spend too much time figuring out ALL the common points in the process. At the first major diversion in country requirements at a higher level, break it into country-specific sections or separate SOPs. There may be some redundant requirements across the countries at this point, but that's ok. It will be easier to manage in the end. :)
 
B

benderspeck

#7
My experience is that some SOPs should be distinct for each country. Even though the process for reporting may be very similar, the auditors may not accept a "single process" for reporting to all countries. I broke out the procedure to deviate and be country specific just to make them happy.
 

Jen C

Involved In Discussions
#8
Thanks so much for all your feedback! It sounds like there isn't one standard way of doing this, which is kind of as I suspected. We are tending to write one procedure that has the general information up-front, then detailed info for each jurisdiction further down. It can make for long procedures though, so I can see where sometimes breaking it out into separate documents would be more appropriate.

Thanks again!
 
Thread starter Similar threads Forum Replies Date
J Should a company create different SOPs for ISO14971? ISO 14971 - Medical Device Risk Management 1
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 6
J Question: How to create an IMDS RoHS, REACH, ELV, IMDS and Restricted Substances 3
M Do we need to create a new CER or can we just update the existing CER EU Medical Device Regulations 3
J Create your own symbol? Other Medical Device Related Standards 7
D How to create IQ, OQ, PQ protocol for existing equipment Other Medical Device Related Standards 2
O How to create robustness checklist from p diagram FMEA and Control Plans 9
T Change control and configuration management - When to create a new model/part number? Other Medical Device and Orthopedic Related Topics 0
R How to create a Work Breakdown Structure? Registrars and Notified Bodies 2
H IMDS for material - Can my Customer create one for my material? RoHS, REACH, ELV, IMDS and Restricted Substances 4
A How do I create a 3^k factorial design with factors be treated as continuous where I Using Minitab Software 0
E How do I create a FMEA for the Internal Audit process? Internal Auditing 11
S Response Surface Method to create design matrix in Minitab Using Minitab Software 5
S Cannot create Rejects for TMV on a medical instrument with an LCD Other Medical Device and Orthopedic Related Topics 10
RoxaneB Carte Blanche to Create an Audit Programme General Auditing Discussions 5
O Is it "legit" to create IMDS before Part Production? RoHS, REACH, ELV, IMDS and Restricted Substances 4
G How to create a mixed OAs in Minitab Using Minitab Software 1
S How to create an Audit Checklist using a Turtle Diagram Internal Auditing 9
A Could I create company specific Employee Records? Records and Data - Quality, Legal and Other Evidence 5
A How to create a Maintenance procedure based on TS 16949 Requirements IATF 16949 - Automotive Quality Systems Standard 5
Ajit Basrur How do I create two different columns in Excel spreadsheet ? Excel .xls Spreadsheet Templates and Tools 5
J Inspection Software to Balloon Drawings and Create First Article Reports Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
T Microsoft Access Database to create a Simple Calibration Certificate General Measurement Device and Calibration Topics 6
R How to create a pop-up message in Excel Excel .xls Spreadsheet Templates and Tools 18
M What is the formula to create a bell curve? Excel .xls Spreadsheet Templates and Tools 8
M ISO/TS 16949:2009 Follow-up Audit Visits to create more Revenue IATF 16949 - Automotive Quality Systems Standard 12
Q Medical Device with Lead (Pb) - Do I need to create an MSDS sheet? Other US Medical Device Regulations 1
B How to use Minitab to create this Fractional Factorial Design Matrix Using Minitab Software 2
C Document Control using Wiki - Cannot Create all Documents as Wiki Pages Document Control Systems, Procedures, Forms and Templates 10
M How to create the Policy for determining criteria for Risk Acceptability ISO 14971 - Medical Device Risk Management 11
T How create a Fractional Factorial Design with Minitab Using Minitab Software 3
A How to create a Multiple Operations Specifications Comparison Spreadsheet? Excel .xls Spreadsheet Templates and Tools 3
K When to create a new Control Chart? Quick question Statistical Analysis Tools, Techniques and SPC 4
A How to create Drop Down Box in Excel 2007 Excel .xls Spreadsheet Templates and Tools 2
N Asked to create a baseline survey on emails that come in and out of our Office Document Control Systems, Procedures, Forms and Templates 1
J How Do Processes Create Value? Article by Paul Harmon Book, Video, Blog and Web Site Reviews and Recommendations 2
W Requirements Traceability Database - Have one? Help create one? Document Control Systems, Procedures, Forms and Templates 1
S HR Manager refusing to create Quality Objectives - Is this a Non-Conformity? Quality Manager and Management Related Issues 11
S How do I create a Technical File for a Class IIa Medical Device EU Medical Device Regulations 5
C SOP (Standard Operating Procedure) on how to create an SOP Document Control Systems, Procedures, Forms and Templates 6
O Need to Create Macros so that it can copy data to the next row.... Excel .xls Spreadsheet Templates and Tools 5
B Who should create training associated with changes to the procedures? Document Control Systems, Procedures, Forms and Templates 7
J Environmental FMEA - Is it possible to create an environmental FMEA? FMEA and Control Plans 12
C Need help to create tracking tool Excel .xls Spreadsheet Templates and Tools 4
L Customer requirement to create a Guide for defining Control Methods FMEA and Control Plans 9
H How to create Stoplight Control charts with excel? Excel .xls Spreadsheet Templates and Tools 16
W Medical Device FMEA vs. ISO 14971 to create our Hazard Analysis ISO 14971 - Medical Device Risk Management 2
B How Can I Create a Bell curve in Excel 2007 Excel .xls Spreadsheet Templates and Tools 7
H How to create a flow for APQP including design and no including design APQP and PPAP 5
V How to create a CAPA (Corrective Action Preventive Action) Database Nonconformance and Corrective Action 3

Similar threads

Top Bottom