Protocol for Customer Audit Response

A

Adia Ed

#1
Hello,

I am a Quality Control Manager for a Dietary Supplement company.

Our company was audited by a customer and they noted some things that I needed to follow up on. Does anyone have a protocol that states what should and should not be provided to the auditor when responding to their findings?

I just don't want to provide too much or too little information when responding.

Thank you!
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Re: Protocol for Audit Response

Hello,

I am a Quality Control Manager for a Dietary Supplement company.

Our company was audited by a customer and they noted some things that I needed to follow up on. Does anyone have a protocol that states what should and should not be provided to the auditor when responding to their findings?

I just don't want to provide too much or too little information when responding.

Thank you!
You should follow a typical corrective action methodology, with correction, root cause analysis, corrective action, verification of implementation and effectiveness, etc...
 

DannyK

Trusted Information Resource
#3
Re: Protocol for Audit Response

Hello Adia Ed

You can ask the customer if he can suggest an acceptable format for your response.
 
Thread starter Similar threads Forum Replies Date
A Inspection Protocol Validation for a Medical Device Customer Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
K Final Acceptance Protocol and Customer Requirements Records and Data - Quality, Legal and Other Evidence 7
M Sterile packing validation tests to be performed and protocol Other Medical Device and Orthopedic Related Topics 1
S Supplier protocol for the Quality Supplier Quality Assurance and other Supplier Issues 6
N Sterilization Protocol Change in Validation Process and further impacts ISO 13485:2016 - Medical Device Quality Management Systems 1
A Verification protocol example Design and Development of Products and Processes 2
P IQ, OQ, PQ protocol, and report templates for Distributed Control Systems in Pharmaceutical Manufacturing Systems. Qualification and Validation (including 21 CFR Part 11) 0
K PQ validation qualification - Asked to write a PQ protocol ISO 13485:2016 - Medical Device Quality Management Systems 6
D Does every piece of equipment used in a laboratory need to have an IQ protocol written and executed? ISO 13485:2016 - Medical Device Quality Management Systems 1
D How to create IQ, OQ, PQ protocol for existing equipment Other Medical Device Related Standards 2
V Protocol, report or SOP for threshold analysis? Human Factors and Ergonomics in Engineering 0
g_ehs Definition Protocol - for Assertions within Genetic Variant Databases Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
E Labware cleaning validation protocol example Qualification and Validation (including 21 CFR Part 11) 1
J EU countries and steam sterilisation protocol EU Medical Device Regulations 0
S IOQ protocol for a Micro-Vu measuring system - Is a PQ required? Qualification and Validation (including 21 CFR Part 11) 2
S IEC 62366 - Usability Test Protocol format Imported Legacy Blogs 0
S Can anyone provide an example of Design Validation Protocol and Report? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
W Audit Protocol Manual which describes best practice Auditing Standards General Auditing Discussions 1
I Requirements for shipping items that fall under the Cartagena Protocol Various Other Specifications, Standards, and related Requirements 4
M Requirements, Verification Protocol and Reports All in One Document Design and Development of Products and Processes 6
E ISO Class 8 Cleanroom Qualification Protocol Template Other Medical Device and Orthopedic Related Topics 6
S Can any one share the Sorting Protocol? US Food and Drug Administration (FDA) 2
K Sample format for Equivalency Protocol /Report Using Minitab Software 5
6 Accelerated Shelf Life Testing Protocol for Juice Containing Beverages Food Safety - ISO 22000, HACCP (21 CFR 120) 1
S Suitable Protocol for Isolation of Clostridium perfringens Food Safety - ISO 22000, HACCP (21 CFR 120) 2
C Reliability Testing Protocol on a new Peristaltic Pump Reliability Analysis - Predictions, Testing and Standards 14
W Production Equipment Cleaning Protocol Example Needed Other Medical Device and Orthopedic Related Topics 2
A Is an IDE required for a study protocol using phantoms and no humans 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S Protocol of water activity measurement and suitable instrument Food Safety - ISO 22000, HACCP (21 CFR 120) 1
J Packaging Validation - IOQ Protocol template for a Sartorius Checkweigher Design and Development of Products and Processes 2
C Preparation for Product Validation Protocol ISO 13485:2016 - Medical Device Quality Management Systems 6
S Medical Device Investigation Protocol Template for Health Canada Canada Medical Device Regulations 1
D Process Validation Protocol (API) as per new FDA Guidelines Qualification and Validation (including 21 CFR Part 11) 18
M Validation Process Protocol related to Medical Devices - Example ISO 13485:2016 - Medical Device Quality Management Systems 2
M Protocol for Validating Pull Tester and Force Gage Qualification and Validation (including 21 CFR Part 11) 9
Anerol C What protocol do you follow to stop the production line? Nonconformance and Corrective Action 9
J Software Acceptance Test (Software Validation) Protocol template Software Quality Assurance 5
M Firmware Validation Protocol/template - FDA regulated Medical Devices industry 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
B Process Validation Protocol for Injection Molding - Looking for training resource Book, Video, Blog and Web Site Reviews and Recommendations 1
Q PCBA Qualification Plan and Protocol example wanted Qualification and Validation (including 21 CFR Part 11) 1
S Internal Audit Checklist or a Protocol Guide wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
W WANTED: Product Stability Protocol - absorbable (resorbable) polymeric resins Other Medical Device and Orthopedic Related Topics 9
J Control of Product Drawings - Engineers don't follow the same protocol ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
R Clean Room AHU (Air Handling Units) - Good Protocol - Recovery Study Qualification and Validation (including 21 CFR Part 11) 8
D Samples from Lots of Incoming Raw Materials - Sampling Protocol Help Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
Ajit Basrur Should the Protocol and Report be signed by the same person(s)? Qualification and Validation (including 21 CFR Part 11) 7
J Electronic Signature Validation Protocol example or template Qualification and Validation (including 21 CFR Part 11) 2
L Establishment of RMA (Returned Material Authorization) Protocol Customer Complaints 10
L GM Mega Supplier - General Motors Mega Supplier protocol regarding APQP help needed IATF 16949 - Automotive Quality Systems Standard 1
S What is the difference between a Test Protocol and a Test Report? Records and Data - Quality, Legal and Other Evidence 9

Similar threads

Top Bottom