Employee Signature List for Medical Device Company

L

Lesley1707

#1
Hi, I am new to the forum and have found all the threads extremely informative and enlightening. Thank you.

I am looking for advice on employee signature lists. I work in a small medical device company that design, develop and manufacture in vitro diagnostics and we are working towards ISO 13485 certification and abiding by 21 CFR 820 regs. We have approximately 30 employees across 2 sites and I seek clarification as to whether our admin department should be included in this list.

L
 
Elsmar Forum Sponsor

GStough

Leader
Super Moderator
#2
Hi, I am new to the forum and have found all the threads extremely informative and enlightening. Thank you.

I am looking for advice on employee signature lists. I work in a small medical device company that design, develop and manufacture in vitro diagnostics and we are working towards ISO 13485 certification and abiding by 21 CFR 820 regs. We have approximately 30 employees across 2 sites and I seek clarification as to whether our admin department should be included in this list.

L
Hi and welcome to the Cove! :bigwave:

What would this list of employee signatures be used for? I'm thinking perhaps you mean for the purpose of controlled document approval with an eye towards electronic signatures at some point in the future?

In a previous life as document control specialist, maintaining a list of approving signature authorities was something I did to keep us out of a bind whenever the major approver was out of the office. Each approving authority had 2 alternates whom they trusted to approve documents in their absence. For each approving authority, I maintained a sheet with their signature, stating that they authorized so and so and so and so to act as their designated alternates in their absence. The approver signed the sheet and each of their alternates signed it, as well.

These forms were updated every 6 or 12 months, and more than once got us out of a pinch when something needed to be revised in a hurry and approval was necessary.

Sorry to be so long-winded, but I hope this helps a little. :bigwave:
 
A

arios

#4
Consider also including in your signature's matrix the employee's initials besides to the signature. I know there is not a prescribed requirement for this but you may do it as a good practice as not always the employees use their printed name and signature but also initials on small spaces as evidence of approval or awareness. This way you have a better way to demonstrate people's identity in records.
 

ScottK

Not out of the crisis
Leader
Super Moderator
#5
Hi

when I worked for a drug and device packager we kept a list of employee signatures and initials based on a recommendation from a couple of our larger customers. The reason was that it made it quick to identify an illegible scrawl of a past employee if need be.

We only kept this file for people signing off on quality records.
So admin was excluded unless they substituted for people signing quality records on occasion.
 

pkost

Trusted Information Resource
#6
I find that the best way to deal with illegible signatures is to ensure that people print their name in caps next to the signature and date; on occasion also their role. This gets around the whole problem of not knowing who signed.
 
M

MIREGMGR

#7
Our HR Department is tasked in the Document Control procedure with maintaining a log of every employee's signature and initials, in conjunction with that individual's secure personnel file. All of our high level approval processes involve specific individuals and their alternates, but many of our production processes require that individual employees sign off as having completed their individual task. We're more comfortable having the entire employee base encompassed by that aspect of the quality system.
 
L

Lesley1707

#8
Thanks guys for all the responses.

Initials are included on the sheet and we have a separate document for approvers / delegates of docs etc. I just thought that as we are such a small company that the admin staff should be included on the list as they deal with purchase and sales orders which, when completed, I would regard as a record. These items are signed off and filed once complete.

I shall readdress the list!

L
 

v9991

Trusted Information Resource
#9
The key is to verify, whether Admin is part of any activities related to Quality!

Primarily, they are entrusted with the responsibility of maintaining the personnel records...further the annual health checkup is one of the activity entrusted with Admin department hence falls in the purview of quality records; So, signatures of the people who are implementing&reviewing that procedure have to be maintained.

hope that helps.
 
Thread starter Similar threads Forum Replies Date
I IAQG AS9104 Definition of Employee AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
D Capturing employee sign off not allowed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M Do employee training records need to be controlled documents? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D Do employee training records need to be centralized? IATF 16949 - Automotive Quality Systems Standard 10
B Employee Handbook in ISO 9001:2015 Section 7 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
Brizilla Employee Data Privacy Policy - ISO 9001:2015 requirement(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
G Internal Audits and Employee engagement Internal Auditing 16
T Question about Quality Department employee position titles Quality Manager and Management Related Issues 10
R How to keep track of employee read-only training ISO 13485:2016 - Medical Device Quality Management Systems 14
qualprod Non conformity, do nothing? Employee experiencing "hard times" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
E Employee complaining about air quality Occupational Health & Safety Management Standards 12
S Testing (Evaluation of) and Verification of Employee Color Vision Human Factors and Ergonomics in Engineering 19
S PPT for ISO13485:2016 Employee Training (Request) ISO 13485:2016 - Medical Device Quality Management Systems 0
S Ways to demonstrate objective evidence that employee is trained and competent ISO 13485:2016 - Medical Device Quality Management Systems 28
C AS9100D 7.1.5.2 / Calibration of Employee Owned Measuring Equipment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J Hardness inspection Audit Finding Employee error Nonconformance and Corrective Action 6
R Employee diet to reduce absenteeism and increase productivity Hospitals, Clinics & other Health Care Providers 24
SATHYABALARAMAN What are the topics to be covered for Training the employee as per IATF 16949:2016 IATF 16949 - Automotive Quality Systems Standard 2
R Use of Employee Assessments for ISO 13485:2016 Training - Internal, External, Online and Distance Learning 1
S Employee Training Matrix - Keeping track of employee training on various SOPs ISO 13485:2016 - Medical Device Quality Management Systems 4
R Defect Display Area for Employee Shift Change Information Misc. Quality Assurance and Business Systems Related Topics 1
M Employee Motivation 7.3.2 & Training including Awareness 7.2.1 IATF 16949 - Automotive Quality Systems Standard 6
E IATF 16949 Cl. 7.3.1 Awareness - Supplemental - Need Employee Testing? IATF 16949 - Automotive Quality Systems Standard 4
M Quality Awareness Slides for Employee Motivation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Need a new video for employee training ISO 9001:2008 Training - Internal, External, Online and Distance Learning 6
R OSHA - How often an employee needs to be Re-Trained on Safety Methods Occupational Health & Safety Management Standards 4
F ISO 9001:2015 - Employee Training Powerpoint .ppt wanted Training - Internal, External, Online and Distance Learning 8
R Managing Employee Training Files - 21 CFR Part 820.25 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
K Online Employee Training Software Training - Internal, External, Online and Distance Learning 1
A Writing an Internal Audit Report Finding for Employee Awareness of QMS Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Q Employee Training - Company Transition 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Could I create company specific Employee Records? Records and Data - Quality, Legal and Other Evidence 5
L Incentives to Encourage Employee Participation Misc. Quality Assurance and Business Systems Related Topics 1
N Employee Reprimanded in Front of Other Employee? Quality Manager and Management Related Issues 21
N What is the best action for employee when employer is paying late? Career and Occupation Discussions 6
E Outstanding Employee Training Records Training - Internal, External, Online and Distance Learning 11
G Tracking Employee Training Software Training - Internal, External, Online and Distance Learning 7
D Value-Added Analysis - Staff (Employee) Satisfaction Quality Tools, Improvement and Analysis 11
Chennaiite Is Audit of Employee Canteen Food within the scope of OHSAS 18001? Occupational Health & Safety Management Standards 17
D "Quality" Gifts to recognize Employee Efforts Professional Certifications and Degrees 7
E Defining Sub-Disciplines for Chemical Testing Laboratory Employee Proficiency Testing General Measurement Device and Calibration Topics 1
S Employee Training Videos for employee ISO TS 16949 Audits IATF 16949 - Automotive Quality Systems Standard 2
J Employee Contracts : Controlled and Uncontrolled Documents Document Control Systems, Procedures, Forms and Templates 6
A Assessing/Mapping Employee Attitude during Competency Mapping (Assessment) IATF 16949 - Automotive Quality Systems Standard 15
P MDD position on Final Inspection/Release Employee Experience/Training EU Medical Device Regulations 1
J Online Employee Testing Sites Training - Internal, External, Online and Distance Learning 5
H Return on Investment of Employee Human Factors and Ergonomics in Engineering 7
I Definition Insubordination in Organizations - Definition, extent; vis-a-vis employee's rights. Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 14
somashekar How to Determine the Necessary Employee Competence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Employee Motivation and Empowerment - TS 16949 Clause 6.2.2.4 IATF 16949 - Automotive Quality Systems Standard 11

Similar threads

Top Bottom