SOP Identification of Special Characteristics

Sambasi

Involved - Posts
#1
I have implemented earliest version of ISO / TS 16949 but new to IATF 16949.
I made an SOP for "Identification of Special Characteristics" Please review and post your comments.

Your feedback will help me to improve the content of this SOP and as well write other SOPs.

Please suggest what can be considered as Performance Indicator for this process

Thanks in advance
SAMBASI
 

Attachments

Last edited:
Elsmar Forum Sponsor

Johnny Quality

Quite Involved in Discussions
#2
Sambasi,

I think you have a good document and I have the following praises and remarks for you. From top to bottom.

  • Do you need a separate "reviewed/approved" and "issued" section? Would you be able to combine them?
  • The Purpose section is good. It's good for documentation to have a scope.
  • The document repeatedly calls for a multi-disciplined team. This is also good, I assume you have a document to reference what "MK / PU / DP/TX, QA / Engg" all are?
  • The Process Manager is empty. Who is directly responsible for the process? A team? Individual?
  • It's good you have "form the team" as step 1.
  • Reviewing historical data is excellent. Learning from lessons in the past. This would also be a good place to mention customer specific requirements.
  • No one is directly responsible for each of the plan-do-check-act sections?
  • In the Planning section you should reference customer specific requirements.
  • The remark in sequence 2 has a typo, "hqw" instead of "how"
  • Should sequence 4 have the title for PFMEA?
  • Should point 1 of sequence 4 reference the DFMEA as an input?
  • Would it be worth mentioning MSA, capacity studies and run @ rates in the Control Plan or Prototype section?
  • At what point is documentation sent to the customer to approval?
  • Does "Mass Production" mean approved by the customer?
  • In the check section it says that performance will be reviewed. How? When?
  • I really like the focus on reducing process variation in the act section. And how will process variation be reduced? By what methods?
  • Which FMEA rulebook are you using? I know JLR's FMEA scoring doesn't (or didn't when we last did a project with them) correlate to the AIAG's. Why is 5 the crossover?
  • Do the phrases "moderate/high risk" and "very high risk" correlate with the FMEA severity scoring? If so, why use both?
I hope this helps somewhat. I have to repeat that responsibility needs to be defined for each of the sequences in the document, otherwise why have that section?
 

Sambasi

Involved - Posts
#3
Thank you for your feedback. It is very encouraging. I will incorporate your comments in the SOP appropriately.
Will you suggest some "Performance Indicator" for the process of identifying special characteristics?
Thanks again.
 
Last edited:

Tagin

Trusted Information Resource
#4
Will you suggest some "Performance Indicator" for the process of identifying special characteristics?
Typically, I think you would be monitoring/measuring things like: customer complaints/SCARs, nonconformances, %defects, etc. Another way to think about it is: what would cause you to go to the ACT stage? what do you CHECK that causes you ACT?
 

malasuerte

Involved In Discussions
#6
I think your "guidelines" of how to select special char is wayyy to broad and vague. I don't know how many parameters you have for this product - but even a slightly complex product could have lots.

Words that cause vagueness:
"Significantly" - what does this mean. Recommend you quantify/qualify this statement
"high impact" - what does this mean. A customer's dissatisfaction will not be equal to yours. You should have a measure.
"moderate/high risk" - ??? risk of what? You need to define
FMEA 5-8 - I don't know your scale, but going down to a 5 - I may reconsider

And since this section is integral, I would redo the section, and move it to the first part of your SOP. If I am going to start a process, I would want to understand my requirements/guidelines/success criteria first. This is just me and the way I write and think.... :)


One general thing - this document has a few items....is this a SOP of how to 'identify SC', as in what are the SC? or is this a document about all to manage SC? Your document seems to imply the first, but is written like the latter.
  • So maybe decide if you need 2 SOPs - 1 for how to determine the SC and 1 for how to manage SC. Because they are different things.
 
Thread starter Similar threads Forum Replies Date
S Incorporating SOP Into ISO 9001 Procedures - 7.5.3 Identification and traceability ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
T Do we need an SOP for ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Y SaMD Verification and Validation SOP and Plan IEC 62304 - Medical Device Software Life Cycle Processes 8
B SOP for CNC turret punching machine for sheet metal process Manufacturing and Related Processes 0
E Procedure ( SOP) for Device Master Record ( DMR ) and for Device History Record (DHR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M WI vs SOP - Shipping/Receiving Document Control Systems, Procedures, Forms and Templates 3
C Language of SOPs and SOP IDs Document Control Systems, Procedures, Forms and Templates 7
H SOP Template for seeking regulatory clearance - MDSAP Document Control Systems, Procedures, Forms and Templates 6
K Looking for guidance to write an SOP on Statistical Methodologies? Statistical Analysis Tools, Techniques and SPC 7
S Converting SOP MDD to MDR Noob ISO 13485:2016 - Medical Device Quality Management Systems 4
K What to include in SOP Definitions section Document Control Systems, Procedures, Forms and Templates 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 6
D Naming of SOP doc's - Specific to Calibrations ISO 13485:2016 - Medical Device Quality Management Systems 2
E SIP/SOP requirements for USB port used for charging IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Anonymous16-2 SOP (Standard Operating Procedure) Numbering Document Control Systems, Procedures, Forms and Templates 7
C SOP Template needed for ISO 13485 6.3 Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 9
C SOP unification. Revision No, Revision history Document Control Systems, Procedures, Forms and Templates 4
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
N Agile SOP for SaMD IEC 62304 - Medical Device Software Life Cycle Processes 3
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 9
R Is it required to have an SOP for external audits? Medical Device and FDA Regulations and Standards News 7
J Looking for a template SOP for UDI implementation for EU Medical Devices EU Medical Device Regulations 1
B How to apply external voltage to SIP/SOP IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Sample Calibration SOP for ISO 13485 General Measurement Device and Calibration Topics 4
J Application of mains voltage on SIP/SOP connectors of medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Q Software SOP - Use and maintenance of an ERP system Software Quality Assurance 6
M What to do in SOP Phase of Head unit testing? IATF 16949 - Automotive Quality Systems Standard 0
H Should I mention machine/Equipment password In SOP? Qualification and Validation (including 21 CFR Part 11) 4
W SOP examples wanted - Soil, Concrete and Asphalt testing ISO 17025 related Discussions 3
F Linking an ISO 31000 Risk management SOP to ISO 17025 ISO 17025 related Discussions 2
pashah Looking for Clinical Evaluation SOP acc. MEDDEV and EU MDR Other Medical Device Related Standards 1
M SOP Sample for BC/ISO22301 (Business Continuity) wanted Business Continuity & Resiliency Planning (BCRP) 4
M Risk/Benefit vs. benefit-risk - Revising an SOP covering Risk Management with the MDR in mind EU Medical Device Regulations 10
A How to manage the QMS system and SOP during the transition from MDD to MDR EU Medical Device Regulations 9
V Protocol, report or SOP for threshold analysis? Human Factors and Ergonomics in Engineering 0
V Nature of references allowed to be cited in the SOP US Food and Drug Administration (FDA) 2
W SOP for Vigilance reporting covering multiple requirements Document Control Systems, Procedures, Forms and Templates 7
M Charging consulting fees for SOP development and guidance Document Control Systems, Procedures, Forms and Templates 14
J Just Venting - Do you refer directly to MDR or you just refer to SOP's? CE Marking (Conformité Européene) / CB Scheme 3
E CSR SHIPPING - Need suggestions for making SOP/WI for our shipping dept (automotive)... Customer and Company Specific Requirements 11
S Should there be a SOP on Cybersecurity? ISO 14971 - Medical Device Risk Management 1
T The difference between SOP and Kaizen Standardization Lean in Manufacturing and Service Industries 2
J Nonconforming product procedures SOP help :) Nonconformance and Corrective Action 2
G NIST SOP 29 - Assignment of Uncertainty - Question General Measurement Device and Calibration Topics 0
A SOP for software validation of software in medical device IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 5
S SOP Training/Competence in 24/7 Operation contractor company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
K EU MDR - PMS (Post Market Surveillance) SOP - definition of "register(s)" EU Medical Device Regulations 2
A Definition Difference between Quality System Procedure and Standard Operating Procedure (SOP) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
I Video under Document Control SOP ISO 13485:2016 - Medical Device Quality Management Systems 2
J Business Impact Analysis SOP Business Continuity & Resiliency Planning (BCRP) 2

Similar threads

Top Bottom