Revision date for SOP (Standard Operating Procedures)

howste

Thaumaturge
Super Moderator
#31
We're back to semantics again...Top Management needn't be meeting in a group to be performing "Management Review", nor do they have to cover all the "input requirements" in one meeting.
You speak the truth. I didn't mention a meeting where all inputs are reviewed at once. The point I want to clarify is who is actually reviewing each of these procedures. I asked if the documents are being reviewed "as a group" because top management (unless there is only one person) is a "group of people who directs and controls an organization at the highest level." If you are saying that a document is reviewed in management review, then the group (all of top management) is doing the review. If one of the members of top management is reviewing the document, it's not being reviewed by top management (which is a group).

Yes, we're talking about semantics. Because the same words mean different things to different people, we need to say things in a way that is clear to all.

I believe there needs to be a "hierarchy of Management Reviews", and that appropriate topics are allocated to the respective review levels, frequency, meetings and managers.
If the organization needs different levels of reviews, they certainly can (and should) have them. The lower levels of reviews may be similar to the management review specified in ISO 13485 (& ISO 9001), but they are not done by top management.

Many organizations have electronic document review which automatically sends the SOPs to their owners when they are "due" for review, based on whatever criteria you have set as a control, as well as criteria controlled by the "Document System Administrator". Those reviews constitute part of the required "System reviews" which must be conducted.

Ownership and review of lower level documents such as Work Instructions and Forms are conducted as appropriate (sometimes as programmed into the database), or as dictated by changes in the "parent" SOP.
What you're describing is good practice, but I don't believe it describes management review.

Yes, Management Review identifies factors which trigger system changes (as previously discussed - Post #18) and delegates the need for SOP changes to their respective owners/champions, and records the action required, by whom, and expected timing, in their Management Review Meeting Minutes. Subsequent Meeting agendas should follow up to ensure that changes have been made, circulated/reviewed/approved (as appropriate), and implemented.
Agreed.
Sorry Howste, I haven't been very explicit in some of my replies, which has possibly contributed to our divergent perspectives. Hopefully, this dialogue has helped us both, as well as other readers.

Patricia Ravanello
:agree1:
 
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howste

Thaumaturge
Super Moderator
#32
No sir! the answer to the question should be in the level-1 or level-2 Quality manual not in the SOP itself.
How and when we revise the documents should be documented in the apex/procedure manual.
V.J.Brahmaiah
I disagree. The standard requires that the controls be in a documented procedure. It doesn't specify what level it should be documented in.
 
B

brahmaiah

#33
I disagree. The standard requires that the controls be in a documented procedure. It doesn't specify what level it should be documented in.
'In a documented procedure' not necessarily in the same procedure.It should be documented in a common procedure applicable to all other documents.There is no differance in our views.
V.J.Brahmaiah
 

howste

Thaumaturge
Super Moderator
#34
'In a documented procedure' not necessarily in the same procedure.It should be documented in a common procedure applicable to all other documents.There is no differance in our views.
V.J.Brahmaiah
Yes, the "procedure" could be documented in more than one document.
 

Jim Wynne

Staff member
Admin
#35
The standard requires us to review documents ' AS REQUIRED'.It doesnot specify any time frame or method of reviewing documents.
No it is definitely not "as required".
It's "establish the controls needed to review and update as necessary and re-approve documents..."
"As required" and "as necessary" mean the same thing in this context, and I agree with brahmaiah when he says that time frame and method are not specified in the standard. If there is a documented procedure that includes rational requirements for review, update and "re-approval," and the organization can show evidence of fulfilling those requirements, the standard has been met.
 

Patricia Ravanello

Quite Involved in Discussions
#36
"As required" and "as necessary" mean the same thing in this context, and I agree with brahmaiah when he says that time frame and method are not specified in the standard. If there is a documented procedure that includes rational requirements for review, update and "re-approval," and the organization can show evidence of fulfilling those requirements, the standard has been met.
You're missing the point. I'm not saying that "as necessary" vs "as required" are in contention, I'm saying the standard is asking for you to define "the controls needed to review...".

Taken out of context, it sounds to me like the organization will do the reviews if necessary, without defining when or how "if necessary" occurs. How can an auditor or an employee know when "if necessary" is?

You need to identify the events/controls that will trigger a review...and the auditor should be able to verify compliance subsequent to those events/triggers.

Patricia Ravanello
 

Jim Wynne

Staff member
Admin
#37
You're missing the point. I'm not saying that "as necessary" vs "as required" are in contention, I'm saying the standard is asking for you to define "the controls needed to review...".
I'm not missing anything. Here's what you said when brahmaiah used "as required" instead of "as necessary":
No it is definitely not "as required".
Taken out of context, it sounds to me like the organization will do the reviews if necessary, without defining when or how "if necessary" occurs. How can an auditor or an employee know when "if necessary" is?
Has anyone disputed this? I didn't. What started the difference of opinion here was your stating that review and re-approval of documents must be a function of 5.6 management review. Now you seem to be saying that so long as the criteria for review are documented, everything is OK (which is correct).
 

Patricia Ravanello

Quite Involved in Discussions
#38
Hello Jim,

Sorry I misunderstood your comment. It appeared that you were focusing on the words "as required" and "as necessary" without addressing the "controls necessary".

Here are the 4 sections of the Standard that I believe impact on the original question posed:

1) 4.2.3 Control of Documents:
A documented procedure shall be established to define the controls needed:
b) to review and update as necessary and re-approve documents

I think we agree, you must identify the controls that ensures that System Documents (including SOPs) are reviewed and updated as necessary.​

2) 5.4.2 Quality Management System Planning
Top management shall ensure that:
b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.


This process is triggered by activities of the Management Review process (see attachment of "Management Review Meeting Minutes", pg 2, for how this "might be" accomplished...not necessarily the only way...)​
3) 5.6.1 General
Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness


Yes, I believe Top Management does review the QMS, since they are collectively the owners of the 12 SOPs (in our system), and they are the ones who maintain and ensure these documents for accuracy and suitability. This is not necessarily accomplished in a "group meeting". Of course, I agree, review of the QMS also refers to "performance review".​

4) 5.6.2 Review input
The input to management review shall include information on:
f) changes that could affect the quality management system, ...


Typically, the "control" or "trigger" for changes to the QMS are output of the Management Review Process (again, see attachment, pg 2). An auditor who sees the sample minutes could then verify that this "control" was implemented by checking to see if documentation was reviewed and edited as required. In a similar way, he could follow the trail to see if Training (if identified as an output) was implemented.​

Again, I think this discussion has been fueled more by the "semantics" of the terminology employed by those posting responses. Management Review needn't be a formalized gathering of the organization's Management Team (in my opinion).

The other point that I think is important is that we understand and demonstrate the "links" between system processes as is required in this instance where "Management Review" and the "Control of Documents and Records" are shown to "interface with each other". The "output of Management Review" can be one of triggers for the "Control of Documents and Records" (as well as for the "Training Process").

Hopefully this helps clear up my perspective.

Patricia
 

Attachments

Patricia Ravanello

Quite Involved in Discussions
#39
I'm with db and Howste on this one; there's no requirement for scheduled review, and there's also no requirement for management review to include review of documents, let alone a requirement (or even a suggestion) that top management should do the reviewing. This is why (for one reason) that the standard expects that responsibility and authority will be delegated.
I didn't say review at "scheduled intervals", I said "planned intervals"....back to semantics.

We "plan" to review the SOPs subsequent to the following precipitous events:

a) When the SOP fails to meet performance objectives.
b) When System Audits identify nonconformances, the root-cause of which lie in the inadequacy and/or inaccuracy of the SOP.
c) When errors/omissions/suggestions for change are submitted to the SOP owner.
d) When there is a process/technological change that impacts on the respective SOP.
e) When there is re-assignment/change in ownership of the SOP.
f) When changes/revisions are identified in sources which impact on the design/documentation of the Management System, including changes in: -
-Corporate/Divisional Requirements
- ISO 9000 (or any other Standard, as applicable)
- Policy Statement
- Customer-specific requirements
- Legal/regulatory requirements.
- Environmental requirements
- Health and Safety requirements...etc., etc.
- Any other requirements/guidelines to which the organization subscribes​

Documents are intended to describe requirements for processes, and when processes change (for any reason) the relevant documents should be reviewed. Establishing a requirement for review of documents when processes change will satisfy 4.2.3(b).
No it won't satisfy 4.2.3 b...You have to ensure that you plan to review documents under any of the conditions mentioned above...and possibly others (this list not intended to be exhaustive). The review does not necessarily guarantee that there will be a "process change" (example...a new standard comes out...the SOP is reviewed for compliance...No changes to documentation are deemed necessary...You still had to have the review). They may result in a 'Process change", but a "process change" is only one event which might trigger a review of an SOP.

Patricia
 

Jim Wynne

Staff member
Admin
#40
Sorry I misunderstood your comment. It appeared that you were focusing on the words "as required" and "as necessary" without addressing the "controls necessary".
Why would I separate those two things? :confused:

Here are the 4 sections of the Standard that I believe impact on the original question posed:
1) 4.2.3 Control of Documents:
A documented procedure shall be established to define the controls needed:

b) to review and update as necessary and re-approve documents
I think we agree, you must identify the controls that ensures that System Documents (including SOPs) are reviewed and updated as necessary.​
Yes, except that I don't think that the designation "SOP" is particularly helpful in these matters. It's an ugly old military term that I think we can do without. In any case, yes, the controls "shall" be identified.
2) 5.4.2 Quality Management System Planning
Top management shall ensure that:
b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
This process is triggered by activities of the Management Review process (see attachment of "Management Review Meeting Minutes", pg 2, for how this "might be" accomplished...not necessarily the only way...)​
No disagreement, and as you say, there are different ways to accomplish it.
3) 5.6.1 General
Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness
Yes, I believe Top Management does review the QMS, since they are collectively the owners of the 12 SOPs (in our system), and they are the ones who maintain and ensure these documents for accuracy and suitability. This is not necessarily accomplished in a "group meeting". Of course, I agree, review of the QMS also refers to "performance review".​
I'm not sure what you mean by "our system" or what 12 "SOPs" you're referring to. If what you're saying is that in your system top management does the reviewing, that's fine, but that's not the way it has ever been in my systems, and there's never been an issue with it either in terms of how well it works or in the eyes of customer and CB auditors.
4) 5.6.2 Review input
The input to management review shall include information on:
f) changes that could affect the quality management system, ...
Typically, the "control" or "trigger" for changes to the QMS are output of the Management Review Process (again, see attachment, pg 2). An auditor who sees the sample minutes could then verify that this "control" was implemented by checking to see if documentation was reviewed and edited as required. In a similar way, he could follow the trail to see if Training (if identified as an output) was implemented.​
I don't agree with your "typically" in the first sentence. In my experience, changes emanate from a variety of sources, including internal audit or just a perceived need to improve something, or changes in processes necessitated by things like new technology. While these changes should be reviewed by management, the output may be something as simple as tacit approval. A person says "We changed process x because of the new machine, and the documentation has been updated," and management might say, "OK, good job," and that's the end of it.
Again, I think this discussion has been fueled more by the "semantics" of the terminology employed by those posting responses. Management Review needn't be a formalized gathering of the organization's Management Team (in my opinion).
I agree that management review may take some form other than a formal, scheduled meeting.

The other point that I think is important is that we understand and demonstrate the "links" between system processes as is required in this instance where "Management Review" and the "Control of Documents and Records" are shown to "interface with each other". The "output of Management Review" can be one of triggers for the "Control of Documents and Records" (as well as for the "Training Process").
It can be one of the triggers, but as I said, it's one of the less likely outputs in my own experience. It isn't just document control that "interfaces" with management review; it's the system as a whole, and the requirement as I see it is for top management to (a) establish the top-level requirements, (b) assign responsibility and authority for meeting the requirements and (c) be aware of the functioning of the system and provide help and resources when necessary. Direct intervention by top management in the day-to-day operation of the quality system isn't necessary or even desirable (imo) unless the company is relatively small. So long as top management has provided the necessary infrastructure and has thoughtfully delegated responsibility and authority, ongoing intervention is likely to become micromanagement, which is not a good thing.
 
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