Blank Fields on Manufacturing Work Instructions

M

Matt Murdock

#1
#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.
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
A

Al Dyer

#2
#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
#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
#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
#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?
 
You must log in or register to reply here.
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