is the translation and approval of the final product design into production documentation, and the assurance that the elements necessary to manufacture and support the product are in place and approved (e.g. production methods and procedures). It ensures that the device design is correctly translated into production specifications.
What is the DHF?
- A collection of records or references to
- demonstrate that the product was developed in accordance with the design and development plan. These records describe the design history of the finished product.
What is the DMR?
- A collection of documents including or referencing the location of the procedures and specifications required for
- producing a specific finished product.
Give 2 examples of new product design change and on market design change.
HBsAg Qualitative assay on project Q
Troponin Assay conversion from OEM to non OEM.
HBsAg Qual II Assay
What are the key indicators a product moves from one phase to another?
- The reviews
- The new vs existing product status
How do activities differ based on the phase of the product?
New product-larger scaled activities
Existing product-smaller scaled activities
- Modifications to an approved design during
- design and development that affect safety, performance, efficacy, intended use, regulatory, or other design input requirements.
What you are going to do.
What you did.
Why you did it.
- Establishing by objective evidence that device
- and device specifications conform with user needs and intended use(s).
- The activity that confirms that the design
- output meets the design input requirements.
- The physical and performance requirements of a
- device that are used as a basis for device design.
- A potential consequence if one element of the Waterfall diagram not performed correctly is develop a product the customer does not need or want.
- Product goes to market and fails or falsely passes.
Select the changes relevant to your site and identify the design element(s) impacted and the verification/validation required.
Changing the formulation by replacing Sodium Chloride with Magnesium Chloride-Design Specification and verify to the P.R.
Swapping from an ethanol wash to a bleach wash to sterilize a vessel surface in the manufacturing area-Mfg to Design Spec.
Changing the vendor catalogue part configuration-mfg and verif. to Design Spec., vendor can actually be the design spec., verify to P.R.
Changing a sample carrier to remove a sharp edge-Design Spec., verify to the P.R.
Decreasing the throughput on a instrument-Design Input, validate to user needs.
- Sample volume to reduce carryover
- Stability-6 months
- Changing the cell line
Discuss the general objective of a design review.
A collection of individuals responsible for the product and one that is not assembled to determine if all req activs have been completed prior to product launch.
Indentify two quality subsystems and describe how they interface with Design Planning.
1. Supplier Eval.-->Testing qualif.-->new specs-->SCP-->DP
2. Complaints-->Design Inputs-->DP
Why it is important to have all required CFT member fully participate in the planning process.
- Determining adequancy, feas., safety of the change needs SMEs.
- Consultation-similar prods experts, lessons learned from other prods.
- Potential conflicts caused by the change-is the factory able to handle.
- Planning to implement the change-inventory, headcount.
Provide 2 examples of output changes with the potential to impact user needs.
Anything related to the P.I.-Sample prep, interpretation of results.
Use own example, how is risk management info used in determining the activities required in the plan e.g. proposed change impacts a mode of control.
Change was prev. done in another prod. RM helps avoid the same mistakes, and helps explain to FDA why something was put in.
Where are the user needs and P.R. docs located?
What are 2 alt. sources of user needs and design inputs if these doc do not exist?
P.I., Reg. submissions, DMR
The assessment process requires all impact assessment questions to be considered prior to determining if a change is a PDLI.
Discuss why this is required.
Doing this forces us to explore all possible impacts.
Discuss why you consider the change at a product or process level first and not at the document level.
This is done so that important details about the change do not get missed.
Give an example of one scope/description pertaining to your area.
Update the ARCHITECT OM HBsAG assay to 2G22/4P53 to incorporate new positive calibrator/positive control with EDTA, PMSF and Diagnostic Grade BSA added to the cal/control matrix. (This update is done to improve stability.)
Creating a DP plan. Learner Outcomes.
Scenario: Develope a next generation Clinical Chemistry instrument (i.e. project Q)
1. Identify the CFT.
2. Does the activity have potential to affect the ability of the product to meet user needs?
3. Is this a PDLI?
4. Is Design Input assessment required?
5. Is Design Validation Assessment required?
6. Is Design Verification Assessment required?
7. Are there RM activities to complete?
8. For the Manuf Strgy and DHF location elements of Design Output/Transfer Assessment discuss what you would assess and plan?
9. How do you determine if a regulatory strategy is required?
10. Outline the sequence of events.
11. Who approves the design plan for pre-approval?
12. Is a Design Input Review required?
13. Who approves the Pre-Market Review?
14. Is a Post-Launch Review required?
15. What action items are required/allowed?
- 1. Quality: Mfg, process, Mat. commodities, New product, stability, validation, FUE for mfg, SW., DHF
- Technical: Mfg, testing val., OM support, R&D, OPs, Mktg, STATs, Labeling, etc.
- 2. new prod.
- 3. yes.
- 4. no.
- 5. yes.
- 6. yes.
- 7. yes.
- 8. yes
- 9. see PPM
- 10. DA-29
- 11. when are the reviews, verif review, valid review
- 12. yes
- 13. see ppm
- 14. yes.
- 15. post launch review is required
What is required to be done before Pre-market review?
CRs, DRs, Deliverables, CAPA
Indentify at least 4 actions that may need to be taken once Pre-Market Approval has been obtained.
- 1. Consult with CFT to remove restrictions in prod. for sale (e.g. mat. disposition)
- 2. manage inventory
- 3. move DMR into production status
- 4. provide an effective date to DHF records.
State the design changes that require a Post-Launch Review. see the PPM
- New Product:
- 1. verification of spec setting assumptions.
- 2. real time stability studies ongoing to support dating extension.
- On Market:
- 1. User needs/intended use change
- 2. Spec setting assumptions need to be verified
- 3. real time stability ongoing to support dating extensions.
Once all action items are completed the DP can be closed. What approvals are required. see the ppm
What additional deliverable is required if there is a DCR associated with a design plan
Provide at least 3 examples of DCR action plan based on impact assessment.
DHF docs, verification testing, labeling
Design Change Requests (DCRs)
Are used to initiate changes to approved inputs or DMR outputs in the design plan.
Give at least 3 examples of events that may trigger the need for a DCR.
Potential NCR (assy file change), Change P.R.s, Supplier Changes. These change design inputs/user needs.
Give an example of a design plan update where a DCR is not needed.
Design Plan-change to stability stategy-Japan launch, they won't accept ALT Stab so need real time stability.
For Change Requests (CRs) what is the procedure followed. Also see the ppm.
The only circumstance where you required to have the CR as part of the design plan.
When verification is tech rational except when PDLI or additional to DMR strat and DV.
Give ex. of when you may process the CR as a stand alone record from the DP
Give ex. of when you may process the CR as part of the design plan (embedded)
Stand-alone CR would be for RM (e.g. dFMEA) update because it is an all document not linked to a specific project but rather a product and for the life of the product.
A CR as part of the DP would be for a Design Record (e.g. Verification Protocol/Record) that has the DP# (CR number) in the title of the design record since it is linked to a specific project as well as the product.
State how you identify the guidance used to complete deliverables.
Provide at least 2 examples of acceptable objective evidence that demonstrate the completion of Deliverables.
Form 07033, deliverables list, requirements.
ELNs, Design records, Manufacturing Records, Lot Numbers, memos.
What types of change require a design input review?
when is a PDMRB DI review required?
What is reviewed at the DI review
what procs are followed
New Product, change to the UN or DI
Deliverables in the pre-apprvl review
see PPM -4&17 (all reviews)
Identify task that may be performed in parallel during the Execute phase.
Work on deliverables, mfg. reagents, create verification protocols.
Discuss how the project coordinator coordinates the init and completion of the design change.
ex. PPM is wrong, project coordinator identifies the dcoument owner and they are both aware of when the completion is needed.
Who approves the DP for closure of Action Items?
Which action items are permitted for new products and which are permitted for on-market products?
see PPM under Action Items.
What is a Deliverable?
Obj. evidence of activity.
A task identified by meeting participants which is assigned to an individual or team that requires followup activity and a report of this activity back to the appropriate board.
Who communicates responsibilities for deliverable and action items?
Who is responsible for completing Deliverables and Action items?
whoever is assigned them and they must be aware they were assign them.
State how the need for a regulatory strategy is signaled?
It is linked to the change code/change type and the submission type (e.g. 510K, PMA) for the product.
What is meant by a "related design plan"?
What is the process for identifying related design plans?
How to identify any actions necessary to address impacts
2 potential consequences of not indentifying impact of other related in-process design plans.
A design plan that is preapproved.
cognos, epas searches of other products.
Ask the CFT
Duplicate efforts, lost time.
Provide an example of a design change that may require additional reviews or intermediate milestones.
All have reviews, multiple Pre-market reviews
Provide an example of a dependency between design plan activities.
Can't start Pre-Market before Pre-IDE
IDE-Investigational Device Exemption
- An investigational device exemption (IDE) allows
- the investigational device to be shipped lawfully for the purpose of a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an
- approved IDE before the study is initiated. Most IVD devices are exempted from having an approved IDE.
Identify at least 2 possible tools/functional areas to assist in the idenfication of essential design outputs.
Tech support, Risk Mgmt File, R&D
Discuss at least 2 ways essential design outputs are utilized.
Testing to determine if you break the product, assessment of the incoming codes for vendors/suppliers (del 210).
For each of the following, identify the design element you trace back to.
design input--->user needs
design output--->design process
design validation--->user needs
design verification--->design input
Identify at least one tool that may used to document trace.
RMF, SDM, DOORS, spreadsheets
State the types of changes that require you to document the DHF location as part of the design plan.
New product development or DHF location change.
Provide an example of:
• a design change that may require additional reviews or intermediate milestones
• dependencies between design plan activities
Additional review is required for a design change that is linked to other design plans.
Completing Gold Box checkout prior to Validation Studies or prior to pre-Market review.
The Method for conversion from the current product to the modified product.
Inventory, forced conversion, ramp up, ramp down, comparison studies.
How will the change be communicated both internally and externally?
Product Information letters, Quality directives, Text in AMM.
Provide a scenario which requires material control during implementation and distribution.
- Don't want V&V out in the field
- Assay file change, new barcodes.
Learning Impact Assessment and Activities
Discuss how to determine the Learning Impact Assessment and Activities
The learning stream group.
Learning Impact Assessment and Activites
Give an example of a change from your own area that would require training activities to be included in the plan.
HBsAg Qualitative II, Qual US, Conf new STP documents (STP 710 and STP 711) are required and will be written for 2G22, 2G23, 4P53 and 4P54. Training of personnel at AIDD sligo on these new specific documents will be needed and require a 4 day training period.
Process and test method validations and verifications
What type of changes would require Process and Test Method activities?
What related document is identified in the PPM to help assess if process validation and verification is required?
Not common process, i.e. purifying antibody, new antibody (identity test).
ADD-PPC-001 (related doc 14)
Design Transfer/Output Assessment and Activities
How do you determine if other sites are impacted.
AMM CR Smartform "where used" search in epas, product knowledge (CFT)
Design Transfer/Output Assessment and Activities
What actions do you need to take when other sites are impacted?
Include the impacted sites on CFT. Follow procedure for change comm. & response (see BP-DSCTL-11 ed 002)
Discuss at least one example of a change that requires an assessment of prev manf or in process material.
HAVAB-G Clinical Brochure specification for controls have tightened. A standard CR is only required for the Clinical brochure update but a lookback on previous activities performed with the prev specs needs to be performed.
Provide 2 examples of methods to identify prev manf material and work in progress
Provide 2 examples of a method/tool to evaluate potentially impacted materials
Additional testing, look at work order to determine activs.
Identify at least 2 different doc to each of following...
The DHF-MSA, User Needs, PAS report, Design Validation Report
The DMR-MFs, SCPs, PSCPs, BOMs, STPs
Discuss 2 reasons why alignment must be maintained between and within the DHF and DMR.
The customer could get hurt.
Identify the key elements for the Design Output/Transfer Assessment and Activities.
Procedure followed for creating RM docs
Other functions that may assist
Action to take if RMF is incomplete
Risk Mgmt plan, Risk analysis, Risk Eval, verfication of risk measures, Risk benefit analysis, Risk Mgt Rpt
On Market Support, Tech Support, DT, R&D Quality
Create an RMF "around the change".
Select at least 3 diff methods/activs and provide an example of a design change for which each is applicable
Perf. Testing-instrument func testing
Thermal Analysis-confirm temp did not exceed spec limits.
File compare-accuracy of SW copies
Design Validation Activs
Sensitivity, specificity, precision, usability testing incl human factors
The design val. designee helps with determining if new val activs are needed.
What is the difference between Design Verif and Design Validation.
Design Validation-clinical studies
Design Verification-In House studies