Referencing other documents in Control Plans

S

Sandy S

#1
I work for an injection molding company. I am revising our control plans. I am making it more general because they are not really used except for during PPAP. Then only used as a required document. The reason is because we have so many other controls. I am still following AIAG Format. Except where I would normally list the control item specification I am putting " Refer to daily inspection standard" or "refer to packing standard". Under packing I am replacing the actual information and putting W/I numbers and "refer to packing standard". Will this be acceptable for a TS Audit? Please Help!!
 
Elsmar Forum Sponsor

qusys

Trusted Information Resource
#2
Re: Control Plan Question

I work for an injection molding company. I am revising our control plans. I am making it more general because they are not really used except for during PPAP. Then only used as a required document. The reason is because we have so many other controls. I am still following AIAG Format. Except where I would normally list the control item specification I am putting " Refer to daily inspection standard" or "refer to packing standard". Under packing I am replacing the actual information and putting W/I numbers and "refer to packing standard". Will this be acceptable for a TS Audit? Please Help!!
We should view it to give an opinion. However to be compliant you shall meet the requirements of Annex A2 of ISO TS.
For a general standpoint, control plan shall be a living document used by the affected personnel and not only for bureacracy. My personal opinion is to put all the requested details in CP.
 

qusys

Trusted Information Resource
#4
I have attached a copy for review... please give me your input.

Thnks
Not sure if it is fully compliant. Some auditor could argument that process parameters are not directly reported in Control Plan but only referenced. Looking at the ISO TS standard, only reaction plan is allowed to be referenced.
However, consider that the auditor check for the effectiveness of the CP. He will interview personnel in all stage of the process flow to assess if the CP is effectively and efficiently used. So, even though the parameters are only referenced and personnel demonstrate in depth knowledge of CP usage, it could issue an observation.
This is my opinion, waiting for additional feedback of more expert Covers too.:bigwave:
 

qusys

Trusted Information Resource
#6
Thank you very much this was helpful.
Appreciate your thanks, Sandy.
Welcome on this forum, that is very precious as a source of information and support. You can find experts that can share ideas, support and advices for all quality issues.
Nice to meet you!:bigwave:
 
Thread starter Similar threads Forum Replies Date
N Referencing of a standard's year in routine regulatory compliance documents Other Medical Device Related Standards 3
M Referencing Standards in Engineering and Regulatory Documents Other ISO and International Standards and European Regulations 1
R Para 4.2.2 b) Referenced Documents - Adequate referencing? Copy and Paste? ISO 13485:2016 - Medical Device Quality Management Systems 5
Q Work instructions - Referencing other documents including procedures Document Control Systems, Procedures, Forms and Templates 18
S Referencing quote on PO AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
M Referencing Harmonised Standards in Declarations of Conformity EU Medical Device Regulations 10
M Referencing the MDR by name in QMS SOPs EU Medical Device Regulations 2
J Referencing Medical Device in FDA records - Package contains several other components Other Medical Device Regulations World-Wide 1
M Informational EC – Guide for referencing standards in public procurement in Europe (JIS Action 11) Medical Device and FDA Regulations and Standards News 0
B Referencing to Supplier Outputs within our Document Control System 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Referencing ISO 9001:2015 clause for Audit General Auditing Discussions 10
S Referencing International Standards as Design Input Design and Development of Products and Processes 5
D Referencing Standards in Procedures - Current version or actual? Document Control Systems, Procedures, Forms and Templates 6
S Referencing procedures on Control Plans - Best Practices FMEA and Control Plans 3
P Question on First Article Inspection referencing ISO 2768 APQP and PPAP 1
J Referencing the DMR (Design Master Record) in the PO Document Control Systems, Procedures, Forms and Templates 2
Q Referencing EN 63204:2006 instead of EN 62304:2006 AC:2008 IEC 62304 - Medical Device Software Life Cycle Processes 9
Q Referencing a Specification in a Work Instruction as a ?Guidance Document? ISO 13485:2016 - Medical Device Quality Management Systems 1
Crusader 7.6 Calibration (referencing outsourcing) in the Quality Manual Quality Management System (QMS) Manuals 5
P Referencing of Forms in Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Referencing the Regulation in a Design Specification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
C Referencing or Using a Master Part to take Measurements Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
R Referencing and Controlling Labels & Stickers used internally throughout Production Document Control Systems, Procedures, Forms and Templates 1
Q AS9100 and NADCAP - Our QM was told that referencing IPC 620 was acceptable AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S Referencing somebody else?s CE Mark and NB Number on an Instruction Leaflet? CE Marking (Conformité Européene) / CB Scheme 7
N Cross-Referencing ISO 9001/ISO 14001/OHSAS 18001 Occupational Health & Safety Management Standards 17
K Question about referencing software - Database Records Document Control Systems, Procedures, Forms and Templates 11
L Surveillance Audit - NC for not referencing requirement of Cl 6.4 in audit plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
A Calling / Referencing National Standards in Quality Manuals Quality Management System (QMS) Manuals 1
C IDE submission - cybersecurity documents 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
N Audit work documents Internal Auditing 3
J Periodic review of Documents during management review Document Control Systems, Procedures, Forms and Templates 24
J Adoption of automotive (AIAG) methods and documents AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S How to deal with customers requesting documents as being in the role of distributor? EU Medical Device Regulations 4
A Metadata For Drugs, API's, Regulatory & Clinical Documents and Dossier Service Industry Specific Topics 2
A List of documents to prepare for Re-certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Document Control - Applying Suitable Identification to Obsolete Documents ISO 13485:2016 - Medical Device Quality Management Systems 5
L Control of Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
Sidney Vianna IAF PR 7:2022 - Requirements for Producing IAF Mandatory Documents on Transitions ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 1
A Technical Documentation => Responsibilities when signing documents ISO 13485:2016 - Medical Device Quality Management Systems 7
A Distribution of controlled documents through e-mail, is it ok? Document Control Systems, Procedures, Forms and Templates 3
P Essential MDR documents IEC 62366 - Medical Device Usability Engineering 0
S Documents belonging to Technical documentation to be stored in one file or spread in the QM system? EU Medical Device Regulations 9
M Documents in EQMS ISO 13485:2016 - Medical Device Quality Management Systems 3
B Documents for production process IATF 16949 - Automotive Quality Systems Standard 8
Watchcat CDRH Proposed New Guidance Documents, FY2022 Other US Medical Device Regulations 2
M Sharing QMS Documents with Customers Document Control Systems, Procedures, Forms and Templates 13
B Need assistance with documents CE Marking (Conformité Européene) / CB Scheme 2
M How to manage Sop's & other quality documents after business transfer Document Control Systems, Procedures, Forms and Templates 3
M How to answer ISO9001:2015 audit finding of old revisions of documents being used? Document Control Systems, Procedures, Forms and Templates 8

Similar threads

Top Bottom