21 CFR 820.20(d) says: Each manufacturer shall establish a Quality Plan

shimonv

Trusted Information Resource
#1
Hi everyone,

21 CFR 820.20(d) says:

(d) Quality planning. Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met.


The pharse "quality plan" is somewhat vague. Can you share from your experiences examples of what might constitute a quality plan in a mature company? and how to make sure businesses don't use it as a 'cover up' for a CAPA..

Thanks,
Shimon
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#3
Re: Quality plannning

Thanks Marcelo,
Can you give an examples for a quality plan? will you use this tool for process improvement or to address backlogs of sorts?

Shimon
 

Kronos147

Trusted Information Resource
#4
Re: Quality plannning

Quality Plan:
Contract Review as per AS9100 8.2.2, 8.2.3
Production Planning as per AS9100 8.5
Inspection as per as per AS9100 9.1.1
Packing, preservation, and shipping as per AS9100 8.5.4


Add more detail (reference you procedures and processes) and that is a quality plan, in my book.
 

Access2hc

Involved In Discussions
#5
It's very similar to a business plan
just that it focuses on your quality objectives (hope you have them) instead of business objectives

hence you can have quality planning for the year, for 3 years, for 5 years, as appropriate to your organisation

it must have goals that are SMART, and hold individuals responsible and accountable (these could be quality or non-quality department people)

and reviewed as part of management review, how-ever frequent you define that

hope it helps.

Cheers,
Ee Bin
Access2hc
 
Thread starter Similar threads Forum Replies Date
P Equipment 21 CFR 820.70(g) - User Requirements Document for Off the shelf equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
Ed Panek 21 CFR Part 820 - FDA Label Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
R Addressing training requirements - 21 CFR Part 820.25 (1) & (2) Other US Medical Device Regulations 4
R How to improve a Validation program and procedures to FDA (21 CFR part 820) & ISO13485 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Marc Problem with 21 CFR Part 820 - US FDA Quality System Regulations (QSR) sub-forum link - 2 May 2019 Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
R 21 CFR Part 820 Contract Manufacturer of Medical Device Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
N Change Control - Compliance with FDA 21 CFR Part 820 Document Control Systems, Procedures, Forms and Templates 3
D 21 CFR Part 820 (Subpart A) - Question about "Authority" 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R RUO audits - CFR 820.22 and ISO 13485 8.2.4 Internal Auditing 3
A Training as well as certifications for ISO 13485:2016, 21 CFR 820... Training - Internal, External, Online and Distance Learning 5
K Production Unit Labeling - 21 CFR 820.184.e 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R 21 CFR Part 820.186 - Types of Quality System Records Document Control Systems, Procedures, Forms and Templates 1
M Does the Scope of 21 CFR Part 820.72 (Equipment) apply to Design? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
V 21 CFR 820 Compliant way to use Kaizen to address Nonconformances Nonconformance and Corrective Action 9
C 21 CFR Part 820.184 - Label Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
V Upgrading Systems from CFR 211 to CFR 820 (drug+device combination) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
S Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 14
Q Internal Audit of Product Quality Complaint System (21 CFR Part 820) Customer Complaints 9
R Managing Employee Training Files - 21 CFR Part 820.25 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Release authorization before or after packaging per 21 CFR 820.80(d)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D Need advice in streamlining antiquated 21 CFR 820 compliant QMS Quality Manager and Management Related Issues 2
J Minimum staff per 21 CFR Part 820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Does a process map satisfy 21 CFR 820.20(d) (Quality Plan)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Calibration of processing equipment - 21 CFR 820.70 Production and process controls 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Issues with UDI additions to 21 CFR 820 requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Interpreting Process Controls - 21 CFR Part 820.70(a) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S How others have defined "reaudits"? 21 CFR Part 820.22 Internal Auditing 1
M FDA 21 CFR 820.250 - Does "valid statistical" always mean math? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
J Document Control Features (Document Content Requirements) and 21 CFR 820.40 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S 21 CFR Part 820.40(b) Clarification on Required Document Approvers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
R Where to find 21 CFR Part 820 Translated into Czech, Spanish, and German 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
N Certificate of Compliance from a Sister Company for FDA 21 CFR 820 Exemption 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Does FDA expect suppliers to be independently assessed to 21 CFR Part 820 ? US Food and Drug Administration (FDA) 4
A Effective Date (of Documents) issue outlined in 21 CFR Part 820.4 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
L Mobile Medical App - Understanding 21 CFR Part 820 Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T "Special Process" Validation Requirements (21 CFR Part 820) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
Y ISO 13485:2003 &FDA QSR (21 CFR 820) Quality Manual,34 Procedures and Form Book, Video, Blog and Web Site Reviews and Recommendations 8
R Policy Statement for FDA CFR 820 Acceptance Activities of Incoming Products. Other US Medical Device Regulations 1
shimonv Storage of finished medical devices per 21 CFR Part 820.150 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
M Does 21 CFR 820.80 (b) require a Supplier to have Receiving Inspection? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
I Does being a subsidiary fully absolve company B from complying with 21 CFR 820? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Help me understand the applicability of 21 CFR Part 820.198 (Customer Complaints) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
A Do controlled documents require a signature on every page as per 21 CFR 820.40? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
P Internal Audit Reports reviewed by management? 21 CFR 820.22 Interpretation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
M Is ISO 17025 accreditation required under 21 CFR 820? ISO 17025 related Discussions 6
5 ISO 13485 relationship to 21 CFR 820 ISO 13485:2016 - Medical Device Quality Management Systems 17
T Design Transfer from R&D to Manufacturing for 21 CFR 820 Design and Development of Products and Processes 2
Q 21 CFR 820.30 - Automated with Computer Software - Applicable? US Food and Drug Administration (FDA) 5
T 21 CFR Part 820.30 Design Controls for Class 1 Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6

Similar threads

Top Bottom