SBS - The best value in QMS software

Manufacturing Plan vs Material Specification vs Control Plan

DuncanGibbons

Involved In Discussions
#1
Is there a formal definition identifying the differences and links between the three?

Am I correct in saying the material spec is what they final part must fulfill, the control plan is a risk-based plan for how to control process-specific variables (the same as a process control document?). Both of which are referenced in the final manufacturing plan (including work instructions, process flow diagrams, required tools etc.)?

Many thanks
 
Last edited:
Elsmar Forum Sponsor

John Broomfield

Staff member
Super Moderator
#2
Manufacturing Plan
Document setting out the specific manufacturing practices, technical resources and sequences of activities relevant to the production of a particular product including any specified acceptance criteria at each stage

Control Plan
A document that describes a system, subsystem, component or material level for products supplied.

Plans are the result of planning which includes preparation. Plans may or may not be validated depending on the risks and consequences of failure.

Both types of plans are live documents that need regularly scheduled reviews to confirm their effectiveness. Plans often refer to specifications.

Materials Specification
Materials specs apply to input materials as well as products that are materials. And to be a spec it must be a document that states requirements (aka: acceptance criteria).

Materials (and Product) Specifications are a result of a design process so expect them to be validated. They rarely refer to plans.
 

DuncanGibbons

Involved In Discussions
#6
How does the control plan link/compare to the process control document (PCD)?

I see the IAQG define a control plan as "A documented description linking manufacturing process steps to key inspection and control activities. The intent of a control plan is to control the design characteristics and the process variables to ensure product quality. "

And a PCD as "A written description of manufacturing/maintenance plan developed to control variation in key characteristics (KCs). It is a living document and is updated to reflect the addition/deletion of KCs."

They seem pretty similar to me.
 
Thread starter Similar threads Forum Replies Date
J Control Plan use on the manufacturing floor FMEA and Control Plans 4
DuncanGibbons Resources for aiding in procedure, work instruction and manufacturing plan development and management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
L Quality Manual for a Quality Plan (Manufacturing secrets?) Request Misc. Quality Assurance and Business Systems Related Topics 1
D API 5CT Compliant Quality Plan for Manufacturing Manufacturing and Related Processes 0
M Manufacturing Process Validation Destructive Testing Sampling Plan Advice Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
I Business Continuity Plan for manufacturing a IVD ISO 13485:2016 - Medical Device Quality Management Systems 4
A Acceptance Sampling Plan for a car manufacturing company Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
D Sample Manufacturing Plan or Template for Medical Device Contract Manufacturer Document Control Systems, Procedures, Forms and Templates 5
V Quality Plan for Development & Manufacturing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
I Do Manufacturing Process Audits Need to be on an Annual Plan? IATF 16949 - Automotive Quality Systems Standard 6
F New Product Manufacturing Plan Timeline template wanted Manufacturing and Related Processes 3
G Manufacturing -> Warehouse -> Tier 1/OEM - Process flow, PFMEA, & Control Plan FMEA and Control Plans 9
Q What is a manufacturing plan? What goes into a manufacturing plan? Various Other Specifications, Standards, and related Requirements 19
G Medical Device 510k Requirements - Plan to expand the manufacturing site in Malaysia US Food and Drug Administration (FDA) 11
A Manufacturing Plan Template or Example wanted Document Control Systems, Procedures, Forms and Templates 16
S Seeking Internal Audit Plan - Design Responsible Manufacturing company Design and Development of Products and Processes 3
A How best can we plan manufacturing process audits? Process Audits and Layered Process Audits 9
S CE and Manufacturing license Manufacturing and Related Processes 1
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
S Critical characteristic on manufacturing operations test procedure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
P ISO 8 classified medical manufacturing room Qualification and Validation (including 21 CFR Part 11) 1
P How to measure DPPM in Chemical batch manufacturing Quality Tools, Improvement and Analysis 1
M MSA Study Type 1 not capable. We are at the limit. And manufacturing wants to continue producing. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
M Office and manufacturing site relocation effect on Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
lanley liao How to keep the manufacturing capability under the API monogram Oil and Gas Industry Standards and Regulations 6
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Ed Panek What are the limits on manufacturing changes and substantial changes? EU Medical Device Regulations 6
Z Rapid audit template for plastic parts manufacturing process Manufacturing and Related Processes 12
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 One CE Mark holder - multiple manufacturing sites EU Medical Device Regulations 3
M Indian Medical Device Rules - Manufacturing and Wholesale Lic. Required? Other Medical Device Regulations World-Wide 12
R Manufacturing plants relocation - Medical Device Medical Device and FDA Regulations and Standards News 7
R Medical Device - Change manufacturing plant Design and Development of Products and Processes 6
P New Global HQ Suggestions for Virtual manufacturing/own brand labelling of medical devices? EU Medical Device Regulations 4
S Manufacturing Execution Systems Software Costs Manufacturing and Related Processes 0
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 5
S PSW - Requirements for "off-the shelf" component that has multiply manufacturing locations Off the Shelf Item Manufacturing and Related Processes 1
DuncanGibbons Additive Manufacturing Processes Thread Manufacturing and Related Processes 5
S Can assembly manufacturing sub-supplier be certified IATF 16949? IATF 16949 - Automotive Quality Systems Standard 6
A ISO 14971 PFMEA Manufacturing Risk ISO 14971 - Medical Device Risk Management 2
L Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
H Line Balancing in Backpack Manufacturing Manufacturing and Related Processes 2
L SAE AS9145 vs. SAE AS6500 (Manufacturing Management Program) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Watchcat Best Regulatory Oversight for Off-Shore Device Manufacturing? Other Medical Device Regulations World-Wide 1
qualprod Automation in manufacturing - Print Shop ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
N Address of Legal Manufacturing Site in ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Description of the requirements of clause 9.2.2.3 manufacturing process audit- needs your feedback IATF 16949 - Automotive Quality Systems Standard 0
M Operational (free) simulation games for manufacturing and quality Lean in Manufacturing and Service Industries 5

Similar threads

Top Bottom