Example of a Registrar's Registration Audit Schedule

T

Teri - 2011

#1
#1
We have had our preassessment to TS 16949 and the document review.
One of the findings for the preassessment was on internal audits, I used that 3rd shift would be audited as appropriate, Our regristrar didn't like it.
Next finding was during the doc. review. Must show how we audit each process along with the system.
We currently do not use a "matrix" to show product audits, instead use the control plans and a "Quality audit checksheet" to do the product audits.

Does anyone have an audit schedule they would care to share? Right now I am having problems in coming up with a schedule that is user friendly in trying to show system, processes along with shifts.

I am probably making this harder than what it needs to be. :frust: But you know how it is! You get started in one path, having problems thinking outside of the box. :bonk:

Would appreciate any suggestions!!
Thanks!! :bigwave:
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
Howard Atkins

Howard Atkins

Forum Administrator
Staff member
Admin
#2
#2
I was certain that the standard said that the product audit should be defined in the control plan. I searched for it but could not find it.

The problem that I see with product audit only being written on the control plan is that it can be forgotten. If you have a reminder system that pops up when needed this should be fine.
This seems to be a practical problem amd not another CB demand for the sake of it.
Remember that process audits 8.2.2.2 are manufacturing process audits
 
D

db

#3
#3
Teri said:
Must show how we audit each process along with the system.
We currently do not use a "matrix" to show product audits, instead use the control plans and a "Quality audit checksheet" to do the product audits.
Click to expand...
Perhaps I'm splitting hairs here, but I see a difference. You begin with "we audit each process", and end with "product audits". If you are using the control plans and a checklist for your process audits, I see nothing wrong with that provided that each auditable process has a control plan. The control plan has the process, the checklist should have the inputs/outputs/metrics, etc. Perhaps, between the two you had major gaps in your process audit. 4.1 b-e is a good way to determine what you need to audit your processes for. It is also possible that the way you perform the audit was not clear in your documentation.

Also, don't forget to meet 8.2.2.1 and 8.2.2.3.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Anerol C In Charge of Safety - New- Safety program Example Occupational Health & Safety Management Standards 4
Eva lee Which is the range for the validated batch size(for example ±5%, 10%) is acceptable? Manufacturing and Related Processes 6
A Control plan for IATF - example? FMEA and Control Plans 1
J Drawing Example Request: Inspection Section Plane of Aluminum Casting Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
A Attribute , for example C chart Statistical Analysis Tools, Techniques and SPC 16
J Example of a defined procedure for carrying out Material Review Board (MRB) Manufacturing and Related Processes 0
S IATF 16949 Internal Audit Example IATF 16949 - Automotive Quality Systems Standard 18
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
optomist1 Paynter Chart Example APQP and PPAP 1
M Data Protection and Privacy Policy - looking for a template/example EU Medical Device Regulations 1
A Verification protocol example Design and Development of Products and Processes 2
Q Example Process orientation to the process leadership, management, goals (tasks of the top management) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q Example of the Risk Template Document Control Systems, Procedures, Forms and Templates 1
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
M Risk managment report of Surgical Mask Example ISO 14971 - Medical Device Risk Management 14
M Example of statement for procedure pack MDR Article 22? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
A 5 x 5 Risk Matrix - Looking for a good example Manufacturing and Related Processes 2
N Post Market Surveillance Package Example Wanted ISO 13485:2016 - Medical Device Quality Management Systems 1
D Calibration Process Flow Map Example Wanted General Measurement Device and Calibration Topics 3
D Redacted 510(k)s - Example wanted Document Control Systems, Procedures, Forms and Templates 17
F Hi friends, can anyone show me an example of a procedure for ISO 13485 6.4.1 Work Environment? ISO 13485:2016 - Medical Device Quality Management Systems 2
DuncanGibbons Looking for example aerospace part CAD files to be used for a case study Career and Occupation Discussions 2
M An example of risk analysis of class I MD ISO 14971 - Medical Device Risk Management 36
Jimmy123 Example of a P-Diagram for Process FMEA - Uncontrollable noises FMEA and Control Plans 39
D Monitoring and measuring resources - Example of how section ISO 9001 7.1.5 would apply to a manufacture of software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Validation of existing equipment - Risk based approach example ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO/TS 22163 Item 5.2.4 Safety policy - Example wanted Other ISO and International Standards and European Regulations 2
F Internal Audit - Procedure example Internal Auditing 5
I Functional Safety Analysis/Report Example IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
H Man Hour Plan 145.A.30 example needed EASA and JAA Aviation Standards and Requirements 0
R Real Example of a currently marketed Procedure Pack CE Marking (Conformité Européene) / CB Scheme 1
D Example for Accessories of "Annex XVI non-medical devices" and how to classify it now with respect ot EU MDR Other Medical Device Regulations World-Wide 1
MichaelDRoach Oganization's Self Declaration of Conformance to ISO 28000 wording example wanted Supply Chain Security Management Systems 1
A Australia TGA Medical Device Sponsor Agreement - Example or Template Other Medical Device Regulations World-Wide 21
J ISO 13485 8.4 Analysis of Data - Procedure example ISO 13485:2016 - Medical Device Quality Management Systems 1
S Question about a basic additive variance/tolerance example Quality Tools, Improvement and Analysis 2
N ISO 9001: 2015 - Example standards policies, procedures, acknowledgements and checklists ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M AS9100d (section 7.1.3) example of compliance in machine shop environment. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
supadrai How does the FDA count violations of, for example, misbranding? (Medical Devices) Other US Medical Device Regulations 1
E Labware cleaning validation protocol example Qualification and Validation (including 21 CFR Part 11) 1
D Laboratory Manual ISO/IEC 17025 Example wanted ISO 17025 related Discussions 2
P Template or example Excel list of ISO certificates issued to clients ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
T Example wanted - Template for internal audit IATF 16949 IATF 16949 - Automotive Quality Systems Standard 1
M Example ISO 14971 policy and risk criteria ISO 14971 - Medical Device Risk Management 0
D System Level FMEA example wanted FMEA and Control Plans 2
E Example of 9001:2015 audit report with non-conformances ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A IATF 16949 Cl. 8.4.1.2 Supplier Selection Process - assessment example IATF 16949 - Automotive Quality Systems Standard 11
D Where I can find an ISO 13485:2016 Audit Schedule example? ISO 13485:2016 - Medical Device Quality Management Systems 4
R Clinical evaluation Meddev (2.7.1 revision 4) - Example or Template EU Medical Device Regulations 4
A IATF 16949 - 9.2.2.1 Internal Audit Programme - looking for example IATF 16949 - Automotive Quality Systems Standard 5

Similar threads

Top Bottom