Requirements, Verification Protocol and Reports All in One Document

Mark Meer

Trusted Information Resource
#1
Another idea I'm mulling over, and would appreciate feedback....

I'm considering creating design documents in such a way that, at the end of the design, the requirements, verification protocol and test-results are included in a single document, which is approved in stages.
(NOTE: this approach is probably only viable for relatively simple devices, and assumes all tests are done internally).

The idea is as follows:
  1. Stage 1. The document starts with a table(s) listing the design requirements. This gets approved.
  2. Stage 2. The document gets revised to add table columns to describe the verification instructions for each requirement. This gets approved.
  3. Stage 3. The document gets revised to add table columns to document test activities.

So, for example, a row in the table may evolve as follows:

Stage 1 (two columns per row):
ID: DR-2.3.1
Requirement: Total packaged system weight shall be less than 500g

Stage 2 (add the following columns):
Verification Method: Weight the packaged system using (equipment reference).
Acceptance Criteria: Measured weight is less than 500g.

Stage 3 (add the following columns):
EUT: Device TPS-1023
Tested By/Date: Joe Bloggs, 2014-09-29
Pass/Fail/NA: Pass
Notes/Observations: Measured weight: 472 grams

Advantages:
- Obvious traceability between requirements and verification activities.
- Only one document to maintain.

(potential) Disadvantages:
- This would be both a document and a record.

Thoughts? Is this approach viable/acceptable?
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Hi Mark,

I see records that also contain instructions and criteria all the time. In fact, I support their premise because the needed information is where it's needed, when it's needed, and presumably current as the document would be getting multiple reviews throughout. What's not to like?
 

Mark Meer

Trusted Information Resource
#3
I support their premise because the needed information is where it's needed, when it's needed...
My thoughts exactly. :)
In previous projects we've had:
1. A design requirements document
2. Several verification protocol documents
3. A test report record for each verification test set
4. A traceability matrix to ensure that all requirements in (1) have been verified by someone in (3) using the methods in (2).

At the end of the day it's a lot to maintain. Particularly when there are changes to a design requirement, nearly all the above needs to be updated.

Furthermore, the "traceability matrix" is a burdensome task in cross-referencing, which would be totally unnecessary if everything was all together in a single table...
 
#4
One thing you need to remember and watch out for with the "one document" approach is how much do you want to put in front of an auditor? The more information presented, the higher risk of generating questions. That's why I would suggest keep your "stage 3" seperate from your one document.

Have your design input requirement, verification method, and design output with a reference to your source of the results (verification report).

An auditor would more likely to spot check and ask for a few reports versus being able to review everything.
 

Helmut Jilling

Auditor / Consultant
#5
One thing you need to remember and watch out for with the "one document" approach is how much do you want to put in front of an auditor? The more information presented, the higher risk of generating questions. That's why I would suggest keep your "stage 3" seperate from your one document.

Have your design input requirement, verification method, and design output with a reference to your source of the results (verification report).

An auditor would more likely to spot check and ask for a few reports versus being able to review everything.
NO, NO, NO...please do not build your system to hide things from an auditor... completely backward approach....


The auditor is there to help you be compliant to requirements, customer requirements, and to help you achieve improvement, better performance and customer satisfaction...by identifying areas which are not compliant or effective.


If you hide things from your auditor because he might say it is a finding, then you are short-circuiting this process. It would be like hiding things from your doctor because you are afraid he might say you are sick...why go to a doctor if you don't want to get well? Why do an audit if you don't want to improve?


If you do not have this kind of relationship with your auditor...then get abetter auditor....
 

matkins

Starting to get Involved
#6
Mark,
Did you ever go further with this idea? If so, would you mind posting it? I'm looking for a means to document design gates and approvals for new and changed products. I like the idea of having it all in one document, showing the complete status of the project.
 

Mark Meer

Trusted Information Resource
#7
For our new projects, we intend to do this, but presently I've got nothing to share.

The idea is however, as described.

Maintain a controlled spreadsheet that is you would add columns to at each stage.
Also, there is a process for revisioning the document:
- v0.x = requirements only stage
- vx.x = requirements + verification protocol stage
- Revision A (B, C, ....) = final design document (requirement+v.protocol+test-record)

So, for example, a single row of this project design document might look as follows:

Stage 1: Design Inputs
|| Req.ID || Design Requirement ||
| 1.2 | Device shall measure 2.4 (+/- 2) mm in diameter |

Stage 2: Verification Planning
|| Req.ID || Design Requirement || Verification Plan || Acceptance Criteria ||
| 1.2 | Device shall measure 2.4 (+/- 2) mm in diameter | Use calibrated calipers to measure the diameter| Diameter measures 2.4(+/-2) mm |

Stage 3: Verification Testing
|| Req.ID || Design Requirement || Verification Plan || Acceptance Criteria || Tested by/date || Equipment Used || EUT || Results ||
| 1.2 | Device shall measure 2.4 (+/- 2) mm in diameter | Use calibrated calipers to measure the diameter| Diameter measures 2.4(+/-2) mm | Jo Personnel, yyyy-mm-dd | (equipment reference) | Unit XXXX | Pass (measured 2.5 mm) |

...That's the idea anyway.
(P.S. hope you can understand my table syntax...pity you can't make proper tables on these forums...)
 
Thread starter Similar threads Forum Replies Date
R Supplier related drawings and verification of process requirements - Source Inspection AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Prashant G AS9100 Requirement - Verification of characteristics results with drawing requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
Sidney Vianna Informational AS13100 A - Delegated Product Verification Training Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
Ed Panek Verification & Validation requirements - Patch that adheres to skin ISO 13485:2016 - Medical Device Quality Management Systems 2
E IATF 16949 Cl. 7.1.5.2.1 - Calibration and Verification Records Requirements IATF 16949 - Automotive Quality Systems Standard 1
R CAPA Verification - ISO 13485:2016 Requirements and Objective Evidence ISO 13485:2016 - Medical Device Quality Management Systems 2
D 820.120 UDI (Unique Device Identification) Labeling Verification Requirements Other US Medical Device Regulations 11
D User Requirements Tracing - Verification and Validation Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
E How to write requirements for Medical App Validation and Verification IEC 62366 - Medical Device Usability Engineering 7
M UDI (Unique Device Identification) Verification Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
H Form that will satisfy Design Review and Design Verification Requirements (7.3) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Meeting 7.4.3 Verification of Purchased Product Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
G AS9100 Clause 7.5.1.1 Production Process Verification Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
J Medical Device Software Verification Requirements Design and Development of Products and Processes 7
D Verification Requirements in a Machining Process Qualification and Validation (including 21 CFR Part 11) 6
Q ISO 62304 (Medical Device Software Development) Verification Requirements IEC 62304 - Medical Device Software Life Cycle Processes 1
P Record Retention requirements of Calibration and Verification Service Providers ISO 13485:2016 - Medical Device Quality Management Systems 11
6 Verification Requirements Matrix for ISO 22000 Food Safety - ISO 22000, HACCP (21 CFR 120) 4
S Audit and Calibration question - does verification alone meet the requirements? General Auditing Discussions 5
P Internal Calibration or Verification - Personnel Requirements IATF 16949 - Automotive Quality Systems Standard 3
T Meeting AS9100 Clause 7.4.3 e) Delegation of Verification requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
B Design Verification - Design outputs not verified against customer requirements Design and Development of Products and Processes 6
C Record Requirements in AS 9100 7.4.3 Verification of purchased product Records and Data - Quality, Legal and Other Evidence 5
A Verification of GM Customer Specific Requirements Customer and Company Specific Requirements 3
M Effect of Sampling on Setup Verification Requirements Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
D Labeling requirements for reagents, etc ISO 13485:2016 - Medical Device Quality Management Systems 3
I Addiotional National requirements for placing MD in the EU countries EU Medical Device Regulations 4
G Tool tracebility and First calibration requirements for aerospace (AS9100) organisation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 4
T Controlled Forms or documented requirements for records? ISO 13485:2016 - Medical Device Quality Management Systems 2
E SIP/SOP requirements for USB port used for charging IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Requirements to obtain ISO 50001 Certification ISO 14001:2015 Specific Discussions 2
L Exemption from the Regulation COVID-19 and QMS requirements EU Medical Device Regulations 2
A ANSI/AAMI versions of 60601-1-2 and related testing requirements Other Medical Device Related Standards 0
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
S PSW - Requirements for "off-the shelf" component that has multiply manufacturing locations Off the Shelf Item Manufacturing and Related Processes 1
D IATF16949 - Interpretation of Customer Requirements clauses Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 2
S Customer Specific Requirements (CSR) not signed/approved IATF 16949 - Automotive Quality Systems Standard 17
B FCA US IATF 16949 Customer Requirements updates Customer and Company Specific Requirements 3
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C Non-EU Language Requirements Other Medical Device Regulations World-Wide 3
A Baby food manufacture - food safety requirements Food Safety - ISO 22000, HACCP (21 CFR 120) 0
S Forced ServiceNow validation - No change in our current user and functional requirements IT (Information Technology) Service Management 6
P Surgical masks ( type IIR) - Cleanroom Requirements EU Medical Device Regulations 3
K IEC 62304 - Functional and performance requirements for SOUP items IEC 62304 - Medical Device Software Life Cycle Processes 2
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D IVD (in vitro diagnostic) Labelling Requirements - 98/79/EC CE Marking (Conformité Européene) / CB Scheme 2
dgrainger Clue to UK's new regulatory requirements - approval of all devices placed on the market? Other Medical Device Regulations World-Wide 1
R Requirements for MDR Article 22 Systems EU Medical Device Regulations 1
shimonv Minimum 60601 requirements for a clinical trial IEC 60601 - Medical Electrical Equipment Safety Standards Series 3

Similar threads

Top Bottom