What does "review" of records actually mean?
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M
MIREGMGR
Re: What does "review" of records actually mean ?
My assumption would be that "reviewed by" would mean the same as "checked and approved by". The check process might include consideration that the record is:
Prepared according to applicable procedure or work instruction, using correct format.
Complete.
Technically correct.
Regulatorily correct.
My assumption would be that "reviewed by" would mean the same as "checked and approved by". The check process might include consideration that the record is:
Prepared according to applicable procedure or work instruction, using correct format.
Complete.
Technically correct.
Regulatorily correct.
S
silentrunning
Craig Cochran, in his book ISO 9001 in Plain English, says to look for:
1. Identification
2. Storage
3. Protection
4. Retrieval
5. Retention time
6. Disposition
By paying attention to these six items records have never been an issue during an Internal Audit or a 3rd Party Audit.
1. Identification
2. Storage
3. Protection
4. Retrieval
5. Retention time
6. Disposition
By paying attention to these six items records have never been an issue during an Internal Audit or a 3rd Party Audit.
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M
MIREGMGR
I took the original question to be in regard to the record creation process, not the record management process.
This list:
is a good one for the latter.
We may need more information on your specific situation to give you better guidance, as this is an FDA topic. For example, from a pharmaceutical production point of view, the context for record review is somewhat different (see below)...
Brian
Review = Check through the entire record for its correctness and completeness.
Obviously this cannot be done without sufficient knowledge and experience.
A review need not be by one person.
Obviously this cannot be done without sufficient knowledge and experience.
A review need not be by one person.
In general, "Review" means that someone knowledgeable (and preferably experienced) in relevant fields is going through the documentation and noting any shortcomings and potential or actual problems, and suggesting improvements.
Normally, it should be a person considered being capable of creating an acceptable version of the reviewed document in the first place, or a specialist reviewing a certain aspect (e.g. a statistician reviewing a document to determine whether statistics were applied adequately and correctly). In the latter case, there may be more than one reviewer, to get a more comprehensive review.
Cheers,
Ronen.
D
DRAMMAN
Is there even a ISO9001 requirement that records must be reviewed? I would consider an Incomming Inspection Report a quality record, but I connot contemplate being required to have someone else "review and approve" every inspection report.
DRAMMAN,
Clause 8.2.3 requires someone to monitor the record keeping as it is a process. Monitors look for evidence of accurate and timely record keeping. Sometimes they find tardy pencil whipping and in some cases the creation of records in advance of the task.
As always, waiting to inspect the product is probably a waste but many people do it because they could not be bothered to monitor the process that resulted in the record.
Besides, checking the veracity of our records does not have to be specified by ISO 9001 for it to make sense. But I must admit I'd rather monitor the process than go thru a pile of records.
John
Personally, I think this is an excellent question.
To me, it's similar to performing maintenance on something. I can perform the work in 3 minutes, or spend three days, depending on the scope and level of detail involved.
There are different levels of review that can be performed on a record. It could be for completeness, adherence to procedures, agree with results, verify training records, checking applicable standards, current revisions, etc.
I have found that actually defining what responsibilities are expected for each level of review (for each particular kind of record) is a helpful thing. In a mature organization with people of different experience backgrounds, there can exist a lot of different opinions on what "review" means.
To me, it's similar to performing maintenance on something. I can perform the work in 3 minutes, or spend three days, depending on the scope and level of detail involved.
There are different levels of review that can be performed on a record. It could be for completeness, adherence to procedures, agree with results, verify training records, checking applicable standards, current revisions, etc.
I have found that actually defining what responsibilities are expected for each level of review (for each particular kind of record) is a helpful thing. In a mature organization with people of different experience backgrounds, there can exist a lot of different opinions on what "review" means.
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