Literature review/HACCP validation of metal detection

#1
Good afternoon, I am wondering how other food manufacturers validate metal detection as a CCP. We have a HACCP where CCPs are annually validated in two ways - a practical/operational validation and a literature review whereby we seek to confirm the appropriateness of the test piece sizes we use to routinely challenge the metal detectors. Previously I have referred back to an FDA document (CPG Sec. 555.425 Foods, Adulteration Involving Hard or Sharp Foreign Objects) that suggests metal contaminants under 7mm in length do not pose a health risk to typical consumers, however this has always felt a little underwhelming.

Any suggestions?

Are there any other sources to refer to that give information on the health risks from different metal contaminants?
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
M Informational US FDA paper – Epidemiological Evidence on the Adverse Health Effects Reports in Relation to Mercury from Dental Amalgam: Systematic Literature Review Medical Device and FDA Regulations and Standards News 0
J Literature Review (marketing etc) ISO 13485:2016 - Medical Device Quality Management Systems 1
N Proving a Medical Device is equivalent to another device from Literature Review EU Medical Device Regulations 4
M MDR Literature search timeline EU Medical Device Regulations 13
M Informational Grey literature and medical devices Medical Device and FDA Regulations and Standards News 0
Watchcat CERs Literature Databases - Searching for data to evaluate EU Medical Device Regulations 16
W Literature used in the clinical evaluation ISO 13485:2016 - Medical Device Quality Management Systems 4
J CER - Literature search strategy and PMV data Timeline - MEDDEV 2.7.1/ Rev 4 CE Marking (Conformité Européene) / CB Scheme 2
SK13485 Can a literature alone be used for the purpose of Clinical Evaluation of a device? EU Medical Device Regulations 6
H CER - Considering similar device/other medical devices for as relevant literature CE Marking (Conformité Européene) / CB Scheme 4
M Clinical Evaluation - MEDDEV 2.7/1 rev4 - Literature route Other Medical Device Related Standards 2
S Literature Search - Notified Body Had Questions About our Rationale CE Marking (Conformité Européene) / CB Scheme 9
K Non-Normal Data Analysis Literature, Websites, Books for Learning Quality Tools, Improvement and Analysis 2
R IQ/OQ/PQ Literature - Learning and implementing IQ/OQ/PQ procedures at my facility Design and Development of Products and Processes 3
A Finding Literature References for Clinical Evaluations per Annex X of MDD 93/42/EEU EU Medical Device Regulations 2
A Quitting ISO 9001:2000 - Necessary Changes to product literature, logos, etc. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
Q Books / Literature: Risk Management for Medical Device Software recommendations Other Medical Device and Orthopedic Related Topics 4
S Clinical Evaluation using the Literature Method - Example or information wanted EU Medical Device Regulations 26
D FDA CGMP's Training Material - Slides, literature, handouts, etc. Training - Internal, External, Online and Distance Learning 1
S How do you let customers know you are certified on your literature? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R ISO 10993 - Required Testing - Can I follow the literature route? ISO 13485:2016 - Medical Device Quality Management Systems 3
Marc Liberating Scholarly Literature with E-Prints and Open Access Journals Book, Video, Blog and Web Site Reviews and Recommendations 0
L How many registrars require the use of their name in company literature Registrars and Notified Bodies 11
L Clinical Data Report - Literature Route - MEDDEV guidance (MEDDEV 2.7.1) EU Medical Device Regulations 28
I Seeking: References for online literature about ISO/TS Implementation Book, Video, Blog and Web Site Reviews and Recommendations 1
C What literature is available on Preventive Action? Book, Video, Blog and Web Site Reviews and Recommendations 7
D Control of Point of Sale Literature Document Control Systems, Procedures, Forms and Templates 3
A 510(k) review timeline 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
S Management Review (9.3) - Management Review Minutes/Report ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
M Forms review Manufacturing and Related Processes 5
V Quality review Meeting with Customer for complaints we received Customer Complaints 6
C Contract Review with Multiple Line items ISO 13485:2016 - Medical Device Quality Management Systems 7
O ISO 13485 - Is management review required before stage 1? ISO 13485:2016 - Medical Device Quality Management Systems 6
G ISO 17025-2017 Management Review reporting items - Inputs ISO 17025 related Discussions 1
I Management review in conformity assessment standards - Certification Bodies Management Review Meetings and related Processes 6
D CSV - Periodic Review Qualification and Validation (including 21 CFR Part 11) 1
qualprod To set frequency to review documents in ISO 9001 7.5? Document Control Systems, Procedures, Forms and Templates 13
S Has anybody done IMS - Management Review Meeting ISO 14001:2015 Specific Discussions 8
T Management review meeting workflow ISO 13485:2016 - Medical Device Quality Management Systems 9
M What to be careful about/focus on when doing a Technical File review EU Medical Device Regulations 4
Watchcat Anyone had an MDR technical file review/audit yet? EU Medical Device Regulations 13
B Label Review for Class II Device US Food and Drug Administration (FDA) 0
A Help with Drawing Review - ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Casana ISO 9001 - 9.3.1 Management Review - Attendees in a flat organization Management Review Meetings and related Processes 6
C Management Review Agenda Management Review Meetings and related Processes 20
Q Do Management Review records have to be on a controlled form? ISO 13485:2016 - Medical Device Quality Management Systems 30
J ISO 9001:2015 Small Operation Management Review General Auditing Discussions 6
F Process Review - What is the ISO requirement for reviewing SOPs and quality documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9

Similar threads

Top Bottom