SOP's (Standard Operating Procedures) - the "write/right" way

A

Asherlee

#1
I work in a medical device company that has SOP’s according to the QS requirements of ISO 13485, the FDA, Canada and the MDD.

I have seen the SOP’s of other companies and almost every company has a different approach in relation to:
1. The method of numbering the SOP’s.
2. The way in which the SOP’s are written, e.g. some companies quote almost verbatim from a standard or regulation; others use their own terminology.
3. The way of writing SOP’s so as to satisfy the QS requirements of ISO 13485, the FDA and Canada, e.g. some companies have a separate SOP listing some of the Canadian QS requirements; other companies integrate Canadian QS requirements into their “general” SOP’s.
4. The method for referencing other company documents, e.g. some companies include other documents in the body of the SOP; other companies simply make a reference to another document.

Of course, we all have to do what is best for us and what works in practice, and we want to use language that is commonly used in business practice, .e.g. instead of saying “process performance and product conformity” we can say “how well our processes are doing and how often we get it right/wrong”.

So my post really boils down to this: based on our experience and on comments/observations received from external auditors, can we please share with each other "major" pitfalls/mistakes to be avoided when writing SOP’s???

Thanks.

Asherlee
 
Elsmar Forum Sponsor

Helmut Jilling

Auditor / Consultant
#2
I work in a medical device company that has SOP’s according to the QS requirements of ISO 13485, the FDA, Canada and the MDD.

I have seen the SOP’s of other companies and almost every company has a different approach in relation to:
1. The method of numbering the SOP’s.
2. The way in which the SOP’s are written, e.g. some companies quote almost verbatim from a standard or regulation; others use their own terminology.
3. The way of writing SOP’s so as to satisfy the QS requirements of ISO 13485, the FDA and Canada, e.g. some companies have a separate SOP listing some of the Canadian QS requirements; other companies integrate Canadian QS requirements into their “general” SOP’s.
4. The method for referencing other company documents, e.g. some companies include other documents in the body of the SOP; other companies simply make a reference to another document.

Of course, we all have to do what is best for us and what works in practice, and we want to use language that is commonly used in business practice, .e.g. instead of saying “process performance and product conformity” we can say “how well our processes are doing and how often we get it right/wrong”.

So my post really boils down to this: based on our experience and on comments/observations received from external auditors, can we please share with each other "major" pitfalls/mistakes to be avoided when writing SOP’s???

Thanks.

Asherlee
Pitfalls
#1: Writing a document that does not say anything. It should describe the best methods and knowledge learned and understood by the organization about the topic at hand. Not just mouthing words from a standard.

#2: Not writing them for your intended audience. You are talking to your people, the users of the process. Not, to an auditor.

Put in meaningful content, make them say something, and give people a reason to want to read them. Otherwise, don't bother.
 

Stijloor

Staff member
Super Moderator
#3
Pitfalls
#1: Writing a document that does not say anything. It should describe the best methods and knowledge learned and understood by the organization about the topic at hand. Not just mouthing words from a standard.

#2: Not writing them for your intended audience. You are talking to your people, the users of the process. Not, to an auditor.

Put in meaningful content, make them say something, and give people a reason to want to read them. Otherwise, don't bother.
May I add that we must verify that the information is understood, comprehended, and can be applied by the intended audience. Communication is a closed-loop process of which the last step - verification of understanding - is often omitted.

Stijloor.
 

Doug Tropf

Quite Involved in Discussions
#4
I would advise against creating procedures that are overly prescriptive. Useless detail is low hanging fruit for auditors - keep it simple but effective.
 
G

Gumaer

#5
#2: Not writing them for your intended audience. You are talking to your people, the users of the process. Not, to an auditor.

While this is sound advice, you must also be careful not to write SOPs only employees of your company understand. Auditors do have to read them and you definitely want to limit the number of questions they ask.

I recently was audited by a large pharma and they offered a couple of suggestions:

1) Remove, or at least limit, acronyms. We all understand this principle, but at my company a few acronyms are so common that line level employees may not understand the document if they were not used. At the same time, the auditor was not fluent in our corporate language and asked for clarification a number of times.

2) Along the same lines, be careful with terminology. One client of ours refers to initial orders going to sites as "Starter Packs." For this reason, it shows up in various documents, signage and was used by employees during interviews and the facility tour.
 
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#6
Why would you write them for anyone else but the people who are employed at the company?

If an external auditor can't ask for an explanation of what an acronym is, during the audit, then you don't need them. Find someone who can. It's a lot easier than changing a whole lot of documents and making folks feel like they have to 'walk around on egg shells' in case they get asked about them! To write this stuff 'to make it easy' - especially for a CB auditor is, quite frankly, the wrong message for those who have to do the job!

You possibly won't know of our fellow Cove contributor, Helmut, since you possibly haven't been around the Cove (well, not many posts) but I can assure you that if he advises what he did - "don't write it for the auditor' he knows what he's talking about! Apart from anything else, he's a very experienced CB auditor who would run rings around those who need a list of acronyms!

It's just dandy, isn't it, for these large corporations staffs to make this kind of suggestion to suppliers? I've seen the same thing happen in the automotive industry. Somewhere along the line they've forgotten that having an effective system isn't about wordsmithing documents to pass audits!
 

Helmut Jilling

Auditor / Consultant
#7
#2: Not writing them for your intended audience. You are talking to your people, the users of the process. Not, to an auditor.

While this is sound advice, you must also be careful not to write SOPs only employees of your company understand. Auditors do have to read them and you definitely want to limit the number of questions they ask.

I recently was audited by a large pharma and they offered a couple of suggestions:

1) Remove, or at least limit, acronyms. We all understand this principle, but at my company a few acronyms are so common that line level employees may not understand the document if they were not used. At the same time, the auditor was not fluent in our corporate language and asked for clarification a number of times.

2) Along the same lines, be careful with terminology. One client of ours referes to initial orders going to sites as "Starter Packs." For this reason, it shows up in various documents, signage and was used by employees during interviews and the facility tour.
I will stand by my suggestion. Your people are the users of these documents, not customers. If your customer speaks Swedish, you aren't going to write them in their language. If you think a short list of acronyms would be useful, then add one for outsiders. Otherwise, they can ask questions. An auditor who does not understand this, is not a very useful auditor.
 
J

JaneB

#8
1) Remove, or at least limit, acronyms. We all understand this principle, but at my company a few acronyms are so common that line level employees may not understand the document if they were not used. At the same time, the auditor was not fluent in our corporate language and asked for clarification a number of times.
Well, re. 'remove or limit', maybe yes but also maybe no. The auditor doesn't work there all the time - employees do. And as you say yourself, they may not understand the document if they weren't used. That's a big bell ringing right there, to use them!!

If an auditor is seriously saying 'I didn't know what that acronym meant, so you should change your system' I'd laugh (if I weren't tempted to cry instead). Do not do it!

You can always include in your system a single list of acronyms/terms that is used to train new people with. And as Helmut says, if an auditor has a problem asking 'what does this acronym mean', they're not an auditor I'd pay much attention to.

2) Along the same lines, be careful with terminology. One client of ours referes to initial orders going to sites as "Starter Packs." For this reason, it shows up in various documents, signage and was used by employees during interviews and the facility tour.
Ding, ding, ding! (That's the bell ringing again). To signal that this is another really good reason to use that terminology!!! If the thing's called a 'Starter Pack', then simply use that name for heaven's sake! What on earth is the point of calling something a 'New Order Preparation and Initial Design Folder' if everyone just calls it the Starter Pack?????

Write the system around people and what things are generally called in that organisation. Not doing this is one reason in my opinion why people get so turned off 'quality'.
 
Q

QA-Man

#9
We numbered our SOP's according to ISO 13485. For example, SOP 822 Internal Audits addresses section 8.2.2 of ISO 13485.

Then we used a regulatory matrix to show how the SOP's meet other regs (like FDA). I attached the matrix in this thread:

http://elsmar.com/Forums/showthread.php?t=8973

Of course when they revise 13485 the system may be a bit off.

If I could do it over I'd use the FDA's numbers. Internal auditing would be SOP 022 and would address 820.22
 

Helmut Jilling

Auditor / Consultant
#10
We numbered our SOP's according to ISO 13485. For example, SOP 822 Internal Audits addresses section 8.2.2 of ISO 13485.

Then we used a regulatory matrix to show how the SOP's meet other regs (like FDA). I attached the matrix in this thread:

http://elsmar.com/Forums/showthread.php?t=8973

Of course when they revise 13485 the system may be a bit off.

If I could do it over I'd use the FDA's numbers. Internal auditing would be SOP 022 and would address 820.22

If you do it over, you might want to generate your own intenral numbers, not linked to a standard. Then, the numbered documents won't change, even if the standard does. All you have to do is change one document - your cross-reference matrix - to adjust for changes in numbers.
 
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