Auditing "process validation" process


Involved In Discussions
Dear All,

Just want to check with your experience regarding conducting (internal/external) audit on the process validation process. With IOT and many processes being software managed, there is a huge amount of data being generated, in particular during process validation, with very limited time, how can internal audit check against the process validation and to identify issues from the mountain of data. Your suggestions and experience sharing is appreciated.
Elsmar Forum Sponsor


Trusted Information Resource
You raise a good point, frequently there isn't time to examine all the data generated in a validation. I would start with checking the obvious things, does the protocol or plan clearly lay out the validation process and is this then followed; does the report match the protocol, was everything signed in the date correct order, look at deviations, calibrations, etc. Then take a sample of the data, follow through one OQ run in detail, then one PQ batch. When time is limited, I would prefer to take a sample of data from 2 or 3 different validations, than try to follow one completely.


Staff member
Super Moderator
I wouldn't want the internal audit team being my quality assurance for process validation team. I would want my internal audit team just to ensure that the approach is compliant and the process was executed as planned. Agree with chris1price that the internal audit would just do a sampling of several validations to assess compliance.
Thread starter Similar threads Forum Replies Date
tony s What is the automotive process approach for auditing? IATF 16949 - Automotive Quality Systems Standard 2
J Recomended Values - Auditing process in a supplier IATF 16949 - Automotive Quality Systems Standard 18
A Suggestions for a UK based course in Process Auditing wanted Training - Internal, External, Online and Distance Learning 2
A Best Method of Auditing an Installation Process at a client job-site ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T Where in the ISO 9001 standard it asks for process based auditing? Process Audits and Layered Process Audits 6
K Auditing New Product Introduction Process General Auditing Discussions 21
P System Audit Approach - Application of VDA 6.3 - Process Auditing VDA Standards - Germany's Automotive Standards 2
L Stability of the Process vs Improvement during Auditing General Auditing Discussions 8
K Process Auditing Clause 7.3 Design and Development Internal Auditing 11
R On Auditing Internal Audit Process - How Independence can be Established Internal Auditing 4
G The future of the Process Approach to Auditing General Auditing Discussions 10
R Auditing a process outside the realm of the formal Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M Process Auditing in a Distribution Company Process Audits and Layered Process Audits 3
M Auditing the Internal Audit Process - 8.2.2 General Auditing Discussions 2
J Auditing the Internal Auditing Process - Audit Nonconformance General Auditing Discussions 3
J Help in Process Auditing - Turtle Diagram Examples Internal Auditing 2
K The Value of Turtle Diagrams in Process Auditing Internal Auditing 27
V Relevance of Process Based Auditing (PEAR) to regulated industry. US Food and Drug Administration (FDA) 3
Q Auditing Management Review - Who audits the management review process? IATF 16949 - Automotive Quality Systems Standard 5
B Process Approach to Auditing Quality Management System Internal Auditing 12
J Auditing the Budgeting Process (ISO 9001) General Auditing Discussions 13
A Auditing sufficiency of documented quality objectives vs the real process Internal Auditing 14
B Internal Auditing of a Process or Workplace? OHSAS 18001 Occupational Health & Safety Management Standards 12
A Green Belt Project for Improving Internal Process Auditing and Metrics Six Sigma 5
K Auditing the Internal Vendor (Supplier) Management Process Supplier Quality Assurance and other Supplier Issues 2
P Auditing Process Classics - I am planning to take CQA exam Professional Certifications and Degrees 5
T Can an Internal Auditor be involved in the process they are auditing? Internal Auditing 8
A Process approach to auditing ISO 9001:1994 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Q Layered Process Auditing (LPA) for a service provider Process Audits and Layered Process Audits 4
A A macro-process structure approach to auditing for ISO 9001:2000(8) General Auditing Discussions 19
D Information Technology Process Audit - Suggestions for Auditing IT IATF 16949 - Automotive Quality Systems Standard 12
Z First time Auditor - Auditing an Outsourced Process General Auditing Discussions 3
J Determining Legal& Statutory requirements while Auditing Design & Development process Design and Development of Products and Processes 8
A Process Approach to Auditing Undocumented Processes at the System Level Internal Auditing 7
W What is meant by Process Approach Auditing and What questions should be asked? Process Audits and Layered Process Audits 11
C Reference Guide for Process Auditors - Yet another Process Auditing Tool General Auditing Discussions 1
H Auditing Lean as a process - Where to begin? Internal Auditing 9
5 Process based Internal Audits, instead of auditing to the elements of the standard Internal Auditing 21
R Auditing Accounting as a Key Process - TS16949 Audit Internal Auditing 6
R Process Auditing - Identifying/Monitoring "Key" Processes Sufficient? Process Audits and Layered Process Audits 5
J Internal Process Auditing - Auditor Unhappy - Wants Layered Process Audits Process Audits and Layered Process Audits 13
V Process approach based internal auditing Internal Auditing 1
S Automotive Process Approach Auditing sanctioned interpretations S1 04 04 General Auditing Discussions 1
P Process vs Elements/Checklist - Is the old method of auditing the clauses still legal General Auditing Discussions 41
H Auditing - System Approach and Process Approach Differences? General Auditing Discussions 20
S Auditing - by department, clause or process? General Auditing Discussions 14
M Internal Auditing of our APQP Process - Who can audit APQP? IATF 16949 - Automotive Quality Systems Standard 5
C Simple four-box process model - Referenced in ASQ Process-based auditing course General Auditing Discussions 5
I Process Auditing for our TS system - Please help and review if you would be so kind Process Audits and Layered Process Audits 7
howste New IATF Sanctioned Interpretation: Automotive Process Approach Auditing ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 14

Similar threads

Top Bottom