Do ALL Quality Records Require Approval?

I

implex

#1
I feel that I understand the principles of good documentation practices and appreciate the expectation that quality records (evidence of conformance to established quality system requirements) need to be legible, properly controlled/retreivable and readily identifiable. But recently, debate has arisen on whether:

1) ALL quality records need to be independently approved
2) Some quality records may be merely signed by the person completing the record (depending on needs of the procedure calling for the record)
3) Some quality records merely need to be controlled (e.g. checked in by an administrator)

CFR 820 is quite vague with respect to the distinctions in terminology between and the handling of quality records and procedural documents. ISO 820 confounds the situation with the specialized use of the terms "Device Master RECORD" and "Quality System RECORD". These special documents are called out for approval along with a number of other documents and records.

13485 language is much clearer.

From your experience, what are the expectations of quality record approval per 820?
 
Elsmar Forum Sponsor
#2
I feel that I understand the principles of good documentation practices and appreciate the expectation that quality records (evidence of conformance to established quality system requirements) need to be legible, properly controlled/retreivable and readily identifiable. But recently, debate has arisen on whether:

1) ALL quality records need to be independently approved
2) Some quality records may be merely signed by the person completing the record (depending on needs of the procedure calling for the record)
3) Some quality records merely need to be controlled (e.g. checked in by an administrator)

CFR 820 is quite vague with respect to the distinctions in terminology between and the handling of quality records and procedural documents. ISO 820 confounds the situation with the specialized use of the terms "Device Master RECORD" and "Quality System RECORD". These special documents are called out for approval along with a number of other documents and records.

13485 language is much clearer.

From your experience, what are the expectations of quality record approval per 820?
Welcome to the Cove :bigwave:

I shall wait for some one to answer you as its close to 11 pm here in India ;)
 
#3
From your experience, what are the expectations of quality record approval per 820?
820 requires two main types of product records, the device master record, and the device history record. They also require QMS records.

My experiences with my clients reflects FDA focuses heavily on the first two. I'm not sure about "approval", but they will look at what is in the device records, and whether they are in good shape.
 
#4
I am back this morning after a tiring day yesterday :)

The approval is a must but could vary on the type of documents. Some examples are provided below.

  1. in case of equipment print outs generated by equipment, "checked by" approval is required. In this case, only signature is required as there is documeted evidence of the parameters.
  2. for a process parameter that needs monitoring, there will be "checked by" and "verified by". This is to verify that person A has done the task correctly. Most of the quality system records that fit into this category shall be compiled as part of the device master records and finally "approved by" a competent person.
  3. where, the procedure has to be approved, there shall be "prepared by", "checked by" and "approved by" sections. Here, the approvers could be one to many depending on the scope of the procedure.


Hope that clarifies. Pl come back if you have additional questions :)
 
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