Blank Fields on Manufacturing Work Instructions

M

Matt Murdock

#1
We utilize a generic setup sheet( work instructions) for our machines. Some fields are not applicable for certain machines. Is it necessary for these fields to be identifed as "n/a" or can they just be left blank. This issue has causes us some confusion. Any input is greatly appreciated.
 
Elsmar Forum Sponsor
A

Al Dyer

#2
Matt,

I don't see it as a major concern although it would be good to have a common methodology. Either on the form or corresponding procedure you could put some type of disclaimer:

ie

"All non-applicable fields must be filled in with N/A"

"Blank fields on this form are considered not applicable"

I think as long as there is a common understanding there would be no internal or external (registrar) concerns, if you can justify and document your position.

ASD...
 
D

Dan Larsen

#3
Generally, I don't like blanks on instructional documents, but as Al mentioned just make sure your system is consistent and understood.

One other thought...you mention "confusion". It might be good to take a hard look at what's causing the confusion with a root cause analysis. Is the root cause a lack of uniform instructions or the presence of the blanks?
 
M

Matt Murdock

#4
The confusion ( better term would be concern) relates to whether the blanks on these instructions can be viewed as a noncompliance by an external auditor.
 
D

D.Scott

#5
Blanks are a big concern to our auditor. Sort of like the basketball ref who watches 3 seconds. We got a nonconformance for ONE. I don't like the idea of stating in the procedure that blank fields are to be considered as not applicable. What if the quality approval of set-up were left blank would it be not applicable? We are stressing that all blanks need to be filled in. If no data is applicable put N/A or - in the space. At least something to show it was addressed. BTW - has anyone else noticed that since "Concerns" were dropped, single observations have become nonconformances and "Opportunities" have become mandatory by next surveillance?
 
Thread starter Similar threads Forum Replies Date
Y Blank Fields on CAPA Form Document Control Systems, Procedures, Forms and Templates 21
H Can 'Not Applicable' Fields on Forms be Left Blank? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
W Form Approval - Blank forms Document Control Systems, Procedures, Forms and Templates 9
A Should I call this ?Blank Template? a Work Instruction? Document Control Systems, Procedures, Forms and Templates 11
S Showing Evidence of Review and Approval of Blank Forms and Templates 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
F Who should provide blank drawings and foundry molding drawings? Manufacturing and Related Processes 3
R Any of you have blank PFMEA and Control plan form that I could use? Document Control Systems, Procedures, Forms and Templates 2
B Can we fill-up blank field or alter information on the records? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
V Control of Forms - Do the blank forms need to be Password Protected? Document Control Systems, Procedures, Forms and Templates 19
smryan How to get chart to ignore text/blank? Excel .xls Spreadsheet Templates and Tools 3
Q FMEA 4th Edition Blank P and D FMEA sheets in Excel .xls spreadsheets FMEA and Control Plans 41
Q Weighing (Weight) Scales Verification - Blank weight of material General Measurement Device and Calibration Topics 13
A Running MRP and Kanban on the same blank/part - Is this possible? Lean in Manufacturing and Service Industries 3
Manix Why are pages left blank on Specifications, Standards, and Directives etc? Document Control Systems, Procedures, Forms and Templates 5
M Blank Form vs. Completed Form - A document or record? Records and Data - Quality, Legal and Other Evidence 11
S IEC 60601-1-2 immunity to proximity fields Test setup - Diagnostic ECG device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Q Change of fields - Quality Engineering Electronics Vs medical Devices Career and Occupation Discussions 20
C PPAP GM 1411 WORKSHEET Fields - Compilation APQP and PPAP 3
Q Change of fields within Quality Career and Occupation Discussions 4
S Putting Data Macros in a Form Fields - Access 2010 Quality Assurance and Compliance Software Tools and Solutions 5
Marc Plowing Carbon Into the Fields to Eliminate the need for Fertilizer World News 12
Manix MS Access Using VB Code Filter - One txt box to search mulitple fields in a record! After Work and Weekend Discussion Topics 23
D ISO 9001:2000 in Hotels Travel & Tourism ‎Fields ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Marc Control Plan content and fields - Format and Reaction Plan - 4.9.1 & 4.9.2 QS-9000 - American Automotive Manufacturers Standard 7
Watchcat Best Regulatory Oversight for Off-Shore Device Manufacturing? Other Medical Device Regulations World-Wide 1
DuncanGibbons Manufacturing Plan vs Material Specification vs Control Plan Manufacturing and Related Processes 4
Q Automation in manufacturing - Print Shop ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
N Address of Legal Manufacturing Site in ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Description of the requirements of clause 9.2.2.3 manufacturing process audit- needs your feedback IATF 16949 - Automotive Quality Systems Standard 0
M Operational (free) simulation games for manufacturing and quality Lean in Manufacturing and Service Industries 5
V Manufacturing requirements for respiratory ventilators - clean room required? Medical Device and FDA Regulations and Standards News 6
J Guidance on manufacturing non-surgical face masks US Food and Drug Administration (FDA) 3
P Manufacturing equipment (e.g.: Dental Welder): medical device or not? US Food and Drug Administration (FDA) 5
S Contagious Diseases in Medical Device Manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 5
C Manufacturing overages & nonconforming material documentation ISO 13485:2016 - Medical Device Quality Management Systems 3
Z US Manufacturing Site Closing, device manufactured elsewhere Medical Device and FDA Regulations and Standards News 1
L Manufacturing site expansion - When to notify your NB EU Medical Device Regulations 3
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N China - Start manufacturing before change approval? China Medical Device Regulations 1
J Manufacturing procedure / work instruction depth ISO 13485:2016 - Medical Device Quality Management Systems 12
F AS9100D, raw material standards are a requirement for manufacturing? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
C Looking for China Good manufacturing practice China Medical Device Regulations 1
Watchcat Does 820.30 include the manufacturing process? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Watchcat Does ISO 13485 7.3 include the manufacturing process? ISO 13485:2016 - Medical Device Quality Management Systems 14
C Design Control - Ways of capturing inputs from manufacturing Other Medical Device Related Standards 5
A Medical Device Contract Manufacturing Requirements and Information - Help wanted ISO 13485:2016 - Medical Device Quality Management Systems 5
K Differences between Manufacturing Process Audit & Layered Process Audit Lean in Manufacturing and Service Industries 4
U Manufacturing solutions and keeping records on quality Content CE Marking (Conformité Européene) / CB Scheme 3
M Informational TGA presentation: How to submit an effective good manufacturing practice clearance application Medical Device and FDA Regulations and Standards News 0
C IATF 16949 8.3 Exclusion - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 5
Similar threads


















































Top Bottom