Records - Are weekly purchasing reports, backlog reports, etc., Quality Records?

kcmomde

Registered Visitor
#1
At my last job we considered such reports as records. So, during the weekly production meetings the materials manager was supposed to bring the purchasing/backlog report, production manager brought the line status report, production control brought the shipping schedule etc. We specified that each of these reports were located with each of these managers as records. Now at my current place of employment they do not do this. Some of the reports they use are generated from our ERP/MRP system & others are not, but they use these reports to make decision that affect on-time delivery etc. so I'm thinking that they need to be considered as records. What's the conscensious on this topic?:confused:
 
Elsmar Forum Sponsor

Miner

Forum Moderator
Staff member
Admin
#2
I have worked with 5 facilities registered to ISO 9001:2000. None of these maintained such reports as quality records. No auditor ever questioned it.
 
J

JaneB

#3
Some of the reports they use are generated from our ERP/MRP system & others are not, but they use these reports to make decision that affect on-time delivery etc. so I'm thinking that they need to be considered as records.
Well, yes they are records strictly speaking. But specifically, they sound like 'temporary working records' or even 'ephemeral records' (particularly those that are generated out of a system, & thus represent a snapshot in time.) And so IMO one treats them as such, including dumping once the temporary need is gone.

More important question I think is, is there a justifiable need to keep them or to treat them formally? If they are only temporary things, leading to completing a task for which the output/task or whatever is recorded, then I'd say probably no. If there might be a need to refer back to them for some important reason, then I'd say yes.

Perhaps analogy = drafts of a document/report. These are 'records' in the sense that they represent the record of thinking/reporting at a particular point. But their use is ephemeral - time-based. So once a particular version is signed off & released, the draft/s can almost always be deleted.
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#4
They're not records according to the following definition.
ISO9000:2000 said:
3.7.6
Record
Document (3.7.2) stating results achieved or providing evidence of activities performed.
 
R

ralphsulser

#5
I have worked with 5 facilities registered to ISO 9001:2000. None of these maintained such reports as quality records. No auditor ever questioned it.
I agree with Miner. These documents do not relate to the quality or performance of the product. The info on these reports are a snapshot of that time. Probably the info on the reports get entered into computer tracking files and discarded.

We have passed 4 TS16949 audits and these type of documents were never addressed.
 
Thread starter Similar threads Forum Replies Date
qualprod What records have to be maintained? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Retention period of documents and records ISO 13485:2016 - Medical Device Quality Management Systems 1
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
T Controlled Forms or documented requirements for records? ISO 13485:2016 - Medical Device Quality Management Systems 2
L Stage 2 audit - Requirement for 3 months of records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
qualprod Records where apply and stop recording everything? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
qualprod From paper to Electronic (records) in the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
C Compliance with ISO 17025 requirement 8.4.2 - Controls - Records recovery ISO 17025 related Discussions 4
J Controlled information versus defined documents / records ISO 13485:2016 - Medical Device Quality Management Systems 3
I When do FORMs and Log Files become Records? Document Control Systems, Procedures, Forms and Templates 9
S Validation Records - Very young QMS Qualification and Validation (including 21 CFR Part 11) 2
B Record Management - Does the QMS need to control templates of records? Records and Data - Quality, Legal and Other Evidence 17
J Integrity of electronic digital records - Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
Q Do Management Review records have to be on a controlled form? ISO 13485:2016 - Medical Device Quality Management Systems 30
J Medical device related standards or regulations - Disposed records log ISO 13485:2016 - Medical Device Quality Management Systems 2
U Manufacturing solutions and keeping records on quality Content CE Marking (Conformité Européene) / CB Scheme 3
S Maintaining Equipment Records - We use a manual system ISO 17025 related Discussions 1
Q AS9120B flow down to external providers: Records Retention AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
F ISO 17025:2017 Format for Procedure and Records Document Control Systems, Procedures, Forms and Templates 3
I Date of Quality Management System - Training Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
I Training records and "grandfather" clauses ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D AS9100 Inspection records - Is there a requirement to have gauge ID and calibration status AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J Dr Training Records - Training doctors to use a PMA approved medical device Other US Medical Device Regulations 2
Q Documenting Customer Complaints (Records) Customer Complaints 6
M Informational EU – Hearing on the SCHEER preliminary Guidelines on the presence of Phthalates in certain medical devices (Brussels, 04 April 2019) – Summary records Medical Device and FDA Regulations and Standards News 0
I ISO 9001:2015 - On the Job Training and Records Training - Internal, External, Online and Distance Learning 4
A Records required for ISO 9001 clause 7.1.5.1 - Fitness for purpose of the monitoring and measurement resources ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Informational USFDA – Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Stand Medical Device and FDA Regulations and Standards News 0
L GMDN code wanted - Software for handling records Service Industry Specific Topics 9
I Training records and levels - When does training NOT need a record? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Q Correction of records - FAR or DFAR? Various Other Specifications, Standards, and related Requirements 3
J Referencing Medical Device in FDA records - Package contains several other components Other Medical Device Regulations World-Wide 1
M AS9100D Competence and Training Records - X-Ray AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
C Karl Fischer Titrators and 21 CTR Part 11 and Paper Records Qualification and Validation (including 21 CFR Part 11) 6
J Calibration/Verification Records (IATF 16949 7.1.5.2.1) IATF 16949 - Automotive Quality Systems Standard 5
I GMP 21 CFR Part 11 Electronic Records Compliance Project Help Qualification and Validation (including 21 CFR Part 11) 9
P Minor Non-Conformance - Maintenance Records Not Fully Completed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
S Where to keep Enterprise Resource Planning software (ERP) Validation Records ISO 13485:2016 - Medical Device Quality Management Systems 1
K Do Forms and Templates ALWAYS become Records? Records and Data - Quality, Legal and Other Evidence 4
S What records are required to show compliance to ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 1
T MDR - Regarding the “Retention Period” of Documents and Records CE Marking (Conformité Européene) / CB Scheme 6
Q Do hard copies of quality records have to be retained? ISO 13485:2016 - Medical Device Quality Management Systems 2
E IATF 16949 Cl. 7.1.5.2.1 - Calibration and Verification Records Requirements IATF 16949 - Automotive Quality Systems Standard 1
S. Moore Record Retention - How long must a company keep the following records? Records and Data - Quality, Legal and Other Evidence 17
R Custom Records and Quality Systems - Products that change frequently Other US Medical Device Regulations 3
A Alternative to keeping hard copy records that is 21 CFR part 11 compliant Document Control Systems, Procedures, Forms and Templates 0
S ISO 13485 Cl. 4.2.5 - Requirements for Control of Records ISO 13485:2016 - Medical Device Quality Management Systems 3
Q AS9100/AS1180-1 - Handling of Equipment and Calibration Records AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
B Quality Records - Should any record be signed? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Records Destroyed - Hurricane Harvey has likely destroyed our Quality Systems Records Records and Data - Quality, Legal and Other Evidence 10

Similar threads

Top Bottom