Compliance of Control Plans to Annex A - Addressing Error Proofing

K

karin

#1
Hello everyone ... I am in the process of updating our Control Plans from QS-9000 compliance to ISO/TS 16949. Annex A of TS is all about Control Plans and I've searched the forum for addressing TS specific requirements but haven't seen anything.

The two things that glare out to me are requirement for error-proofing under "methods" and the requirement for corrective action under what used to be the "reaction plan" area but is now "reaction plan and corrective action".

If I change the headers to my basic control plan for reaction plan/cor action and add a column for "error proofing", and then added references to our PFMEA and our corrective/preventive action procedures, would I be meeting the additional requirements?

Thanks for any help you can give!

Karin
 
Elsmar Forum Sponsor
B

Bill Ryan - 2007

#2
I have not changed headers in our Control Plans. I address the "error proofing" in the "Evaluation/Measurement Technique" column and our "corrective actions" are simply a reference to our nonconforming procedure in the "Reaction Plan" column. Personally, I don't get real excited about format - I'd rather concentrate on content (JMHO).
 
K

karin

#3
Hi Bill ... thank you so much for your input. Following your suggestions our control plans are compliant. It's just after 8 years of being part of registration and surveillance audits, sometimes I like to do everything but club the auditor over the head with the obvious, and changed column headings would certainly do it. I like them to have to ask a few questions as possible!!

Thanks again!!

Karin
 
B

Bill Ryan - 2007

#9
Tom

Wouldn't the "microprocessor - guarantee soak point and soak band alarm" and the "microprocessor alarm" be "preventative" and belong in the Error Proofing column? Unless, of course, there is just an alarm and the process keeps "running".

I guess your format doesn't look as "busy" as I thought the additional column might make it. I still don't subscribe to the need for it. Based on the above, if you have an "Error Proofing" entry, does that mean you wouldn't need an entry in the "Evaluation ..." column?? I can see where it might get rather confusing (but that is far from a rare occurence with me :confused: ).
 
T

Tom W

#10
Bill Ryan said:
Tom

Wouldn't the "microprocessor - guarantee soak point and soak band alarm" and the "microprocessor alarm" be "preventative" and belong in the Error Proofing column? Unless, of course, there is just an alarm and the process keeps "running".
You are right Bill - The example I uploaded was a copy of one that we were working with last year when we went to TS (it is not the finished product). We actually had to take a hard look at the error proofing column and decide what impact it would have on the existing control plans. It is a process that we still, a year later, are still working with it to "get it right" for our business.
 
Thread starter Similar threads Forum Replies Date
D Control chart applicable? Percentage of compliance with a standard Statistical Analysis Tools, Techniques and SPC 2
N Change Control - Compliance with FDA 21 CFR Part 820 Document Control Systems, Procedures, Forms and Templates 3
J Compliance with ISO 9001 Clause 7.6 Control of Monitoring & Measuring Devices ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
N Document Control - Is this in compliance with ISO 9001:2000? Document Control Systems, Procedures, Forms and Templates 31
Douglas E. Purdy Control Plan Compliance [PPAP 3.1] & Drop Shipments IATF 16949 - Automotive Quality Systems Standard 9
G C4i - Control, Capability, Compliance and Continuous Improvement? Preventive Action and Continuous Improvement 8
E Test report to certify compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 1
E Accredited vs. non-accredited labs for 60601 compliance in the US IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Accredited vs. non-accredited labs for 60601 compliance in the US Other Medical Device Related Standards 0
M Class II type machine , and its compliance with 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 14
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
H Automotive wires - Compliance with USCAR21-4 & USCAR38-1 Various Other Specifications, Standards, and related Requirements 0
M FULFILMENT of compliance obligation versus COMPLY with compliance obligations ISO 14001:2015 Specific Discussions 2
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
L Medical device HIPAA compliance in encryption Medical Information Technology, Medical Software and Health Informatics 1
J Strategy for MDR Regulatory Compliance Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
G Adopting old product - compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
M Advice needed for SEH Compliance Software and ISNETWord Compatabiliy Occupational Health & Safety Management Standards 2
D HIPAA, HITECH and Interoperability compliance route Medical Device and FDA Regulations and Standards News 2
A Environmental Compliance obligations and risks (ISO 14001:2015 6.1.3) ISO 14001:2015 Specific Discussions 3
M Tracking Expiration dates on compliance certifications REACH and RoHS Conversations 2
T Training recommendations? Bringing our RoHS and REACH compliance efforts in-house REACH and RoHS Conversations 2
optomist1 Informational Training IMDS - Management of Product Chemical Regulatory Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 2
G ISO 14001 - 6.1.3 Compliance Obligations ISO 14001:2015 Specific Discussions 1
Ed Panek Compliance with Standards? When a standard is updated/revised CE Marking (Conformité Européene) / CB Scheme 3
K IEC 62304 compliance - Code reviews as part of verification strategy IEC 62304 - Medical Device Software Life Cycle Processes 5
N Which EN ISO 17664 version compliance to EU MDR? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 8
C Compliance with ISO 17025 requirement 8.4.2 - Controls - Records recovery ISO 17025 related Discussions 4
J Management Representative and PRRC (Person Responsible for Regulatory Compliance) ISO 13485:2016 - Medical Device Quality Management Systems 10
N Audit non-compliance - API Spec Q1 9th Ed 5.6.1.2 b Oil and Gas Industry Standards and Regulations 10
J Interesting Discussion Compliance with regulations in exceptional circumstances EU Medical Device Regulations 5
L Wearables 21 CFR Part 11 compliance Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
V Preparing the IFU in compliance with MDR 745, Chapter III EU Medical Device Regulations 2
L AS9146 Implementation and Compliance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P MDR PRRC (person responsible for regulatory compliance) and personal liability EU Medical Device Regulations 3
R Foam mattresses used in hospitals - compliance with MDR requirements? EU Medical Device Regulations 6
E Machines in Europe not in compliance with the EC directive CE Marking (Conformité Européene) / CB Scheme 0
N EUDAMED postponement and compliance with Article 120 (3) MDR for Legacy Devices EU Medical Device Regulations 8
R Role of quality compliance in SAP Software Quality Assurance 2
E Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
M MDR Legacy Medical Device Labeling compliance timeline EU Medical Device Regulations 3
D Required Checklist Showing Compliance to IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 11
D What is the best software used for the pharma compliance management? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
T Rumours that class 1 NS, NM, NR devices will have a new deadline for MDR compliance EU Medical Device Regulations 3
M Informational From RAPS: Danish Regulators Seek to Help Smaller Companies With EU MDR Compliance Medical Device and FDA Regulations and Standards News 0
G ISO 9001 Legal Compliance and Legal Register Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Ed Panek Do Cloud services require 21 CFR Part 11 compliance? Qualification and Validation (including 21 CFR Part 11) 7
R Certificate of compliance to RoHS/REACH/WEEE - any such animal? REACH and RoHS Conversations 18
Sidney Vianna Interesting Discussion Legal compliance as part of ISO 45001 accredited certification. Major OSHA penalties in the USA. Occupational Health & Safety Management Standards 15

Similar threads

Top Bottom