SBS - The best value in QMS software

Can a single Form be used for multiple Processes?

B

Billy M

Starting to get Involved
#11
#11
DietCoke1953 said:
Does anyone utilize just one form for reporting Customer Complaints, Non-Conforming products, audit non-conformances, credits, warranties...etc.

Would be interested in reviewing such a process or form, or comments and suggestions.

Many Thanks,
Click to expand...
Attached is a form I use for NCR, CAR, PAR, Customer Complaints, Supplier Issues, etc.
 

Attachments

Quickly Organize an Intelligent TDP from DISCUS
Elsmar Forum Sponsor
Randy

Randy

Super Moderator
#13
#13
Just make sure that whatever you decide, do it!

Currently I'm performing a multi-person Team, certification reassessment audit of an organization to ISO and other standards, and one of the major non-conformities we are issuing is about "forms" not being used as required. They have literally a ton of system "forms" that they were going to use to record "this and that and everything else", but they are not using them, so consequently when I conduct the closing meeting tomorrow there will be no recommendation for continued certification. This is nothing but a self inflicted wound.

Don't get trapped by the "if one form is good then lots of forms are great".

Forms are used to record information and thus become records, which are an absolute must have.

But, before you do anything, make any decision and waste the most valuable resource your organization has..."the available time of its people" ask a couple questions...And be honest with the answers:

1) Do we really, actually, honestly, need these forms?

2) Are we really, actually, honesty going to use these forms?

If you cannot give a real, actual, honest, no-%hit YES to both of those questions, then use your time to do something of value and productive.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S DHF/DMR/MDF for a software-only, cloud-based, single-instance device Medical Information Technology, Medical Software and Health Informatics 2
N Is this a single integral drug device combination product EU MDR CE Marking (Conformité Européene) / CB Scheme 1
R CND nomenclature for single use instruments CE Marking (Conformité Européene) / CB Scheme 1
P Violation of CE mark - Re-use of single-use Products CE Marking (Conformité Européene) / CB Scheme 2
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
D SINGLE FAULT CONDITION, short circuit and open circuit of any component (IEC 60601-1 3.1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
shimonv Single lot release for sterile packaging 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
N Where to find Regulations for Reprocessing and Reuse of Single-Use Devices Other Medical Device Related Standards 2
T Single Fault Condition IEC 60601 Clause 8.7.1 shorting Cr/Cl in Patient Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
D Partial FAI - AS9102 - One single drawing has 10 part numbers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Sidney Vianna Informational IAF and ILAC Seek Contractor for Establishment of a Single International Organization for Accreditation ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 2
F UDI - Unit of Use and Class I, single-use devices EU Medical Device Regulations 4
A Single use non-sterile syringe used in the oral cavity - Laboratory test advice US Food and Drug Administration (FDA) 7
D How to get EUDAMED Single Registration Number (SRN) EU Medical Device Regulations 17
CycleMike GD&T - Hole pattern - Print (attached) has a single Datum Reference Frame Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
K Does company who manufacture but does not design or carry out clinical trials is responsible for CE marking for single use medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 3
F 2017/745 Article 31 Single Registration Number Medical Device and FDA Regulations and Standards News 5
M Informational EU draft act – Single-use medical devices – safety and performance requirements for reprocessing Medical Device and FDA Regulations and Standards News 0
Q IATF rule for single site - Ingots from scrap metal recycling company IATF 16949 - Automotive Quality Systems Standard 0
R Supplier Controls we can place on Single-Source Suppliers ISO 13485:2016 - Medical Device Quality Management Systems 2
R Critical suppliers (Definition of) and MDSAP (Medical Device Single Audit Program) ISO 13485:2016 - Medical Device Quality Management Systems 15
A Touch current in single fault conditions test and earth leakage current in normal conditions test, are they really different tests? IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
Ed Panek Can a single supplier fit two or more categories for risk? ISO 13485:2016 - Medical Device Quality Management Systems 2
T No Defined Shelf Life/Expiration Date - Disposable single-use, non-invasive, non-sterile Other Medical Device Regulations World-Wide 2
F Reprocessing or refurbishing? Single Use Medical Device CE Marking (Conformité Européene) / CB Scheme 0
S How to make Single Sign On (SSO) Comply e-sig requirements? ISO 13485:2016 - Medical Device Quality Management Systems 4
E Sample size for design verification of variable in single use device Design and Development of Products and Processes 20
Ed Panek Sensitive Supplier Issue - Single source supplier ISO 13485:2016 - Medical Device Quality Management Systems 6
G Single DFU for multiple medical devices in one box Other Medical Device Regulations World-Wide 0
M Medical Device News Health Canada - Medical Device Single Audit Program (MDSAP) Transition Plan Canada Medical Device Regulations 2
A ISO 2859 Single Sampling - Clarification regarding the sampling table Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
bio_subbu Indian government issues guidance on Grouping Medical Devices in a Single Submission Other Medical Device Regulations World-Wide 1
F Marketing a single medical device with multiple indications Other US Medical Device Regulations 4
G IEC 61010 - Single Fault Condition - Protective Impedance Implementation IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
T Definition Sole source VS. Single Source - Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
Edward Reesor MDSAP (Medical Device Single Audit Program) Costs Canada Medical Device Regulations 7
Mikey324 GR&R - Little to no part to part variation in single part number Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 14
R How many Corrective Action Request can be Issued by DCMA for a single issue? Nonconformance and Corrective Action 2
I Label Expiration Date - Single Use Combination Medical Device EU Medical Device Regulations 2
M What are Single Fault Conditions and how to test - IEC 80601-2-13 Other Medical Device Related Standards 0
M Merge Technical File, DMR, and Device File into a single document? Other Medical Device and Orthopedic Related Topics 3
P Single Use Disposable Dental Syringe - CE Marking Advice EU Medical Device Regulations 4
S IEC 60601-1 - Label Physical Requirements for Disposable (Single Use) Medical Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
E Single Fault Condition Simulation IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N Reliability Testing of a Single-Use (Disposable) Medical Device Reliability Analysis - Predictions, Testing and Standards 4
R Standards Specific to Single Channel ECG Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Ronen E FDA encourages industry to participate in Medical Device Single Audit Program (MDSAP) Other US Medical Device Regulations 10
J QMS and ISO 9001 for a Single Person Machine Shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
P Question related to Single Fault Conditions IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T Single Point Contact / DoC CE Marking (Conformité Européene) / CB Scheme 2

Similar threads

Top Bottom