New product development
Product development: why the app refuses
Every message the product development pages can show, what it means, and what to do next.
The app refuses a step to keep the controlled record true: a released document does not change by accident, and nothing is released with a gap. A refusal changes nothing; fix the cause and try again. Messages about signatures, signing authority, training and field ranges are the same in every flow and are explained in Signatures and common refusals. Messages about engineering change notes are in Engineering changes: why the app refuses.
View as text
%% title: Why a controlled document refuses a change
flowchart TD
A["You change a product, method, work instruction or a line of it"] --> B{"Is the document a Draft?"}
B -->|"Yes"| C["Saved"]
B -->|"No"| D["Refused: start a new revision"]
D --> E["Raise an engineering change note"]Start a development item
Task page: Start a development item.
Move to the next stage
| Message | When | What it means | What to do |
|---|---|---|---|
Record the specification lines first | Pressing Move to DFM review with no specification gap recorded | An empty list is not a specified item. | Add the gaps and close them. |
Close the specification gaps first | Pressing Move to DFM review with a gap still open | The item is not specified well enough to review. | Close each gap, or remove one that no longer applies. |
Record the DFM checks first | Pressing Move to Trial with no DFM check recorded | An empty list is not a review. | Add the checks and pass them. |
Complete the DFM review first | Pressing Move to Trial with a check not passed | The DFM review is not finished. | Pass each check. |
Link the product first | Pressing Move to First article or Approve · qualified with no Product | The item must name the product it develops. | Choose Edit and pick the Product. |
Qualified needs an accepted first article for {pn}, a validated process and the customer's approval reference. | Pressing Approve · qualified | Only the missing parts are named, so the message can be shorter. A customer's approval reference is needed only when the item names a Customer. | Get a first article accepted, finish the process validation, or write the Customer approval ref.. |
This step needs a QA manager signature. You are signed in as {name} ({role}). | Pressing Approve · qualified as anyone but the QA manager (or a delegate) | The QA manager signs a development item as qualified. | Ask the QA manager. |
This is a controlled record. Enter the reason for the change. | Saving an edit to an item without a reason | A development item is controlled. | Write the reason of at least four characters. |
This item is already qualified. | A second Move to at Qualified | There is no next stage. | None. |
Development item {key} was not found. | Closing a gap or passing a check on an item that was deleted | Reload the screen. | |
That item was not found. | Closing or reopening a gap or check that no longer exists | Another person changed the list. | Reload the screen. |
Regulatory requirements and cleanliness
| Message | When | What it means | What to do |
|---|---|---|---|
Enter the requirements passed to General / Enter the source / Enter the requirements passed to General, source | Approve or Record review on a regulatory requirement with those fields blank | The requirement cannot be approved without what is passed on and where it comes from. | Fill in Requirements passed to General and Source. Only the blank ones are named. |
Enter the specification / Enter the verification method / Enter the acceptance limit (two or three joined by commas) | Approve on a cleanliness requirement with those fields blank | Fill in the named fields. | |
Enter the last result and whether it is OK | Record verification with Last result or Last result OK blank | Fill in both. | |
Failed cleanliness verification: link an NCR | Record verification with Last result OK set to No and no NCR | A failed verification needs a nonconformance report. | Raise the NCR and select it in NCR. |
Set up items and products
Task page: Set up items and products.
| Message | When | What it means | What to do |
|---|---|---|---|
Factor must be greater than zero. | Saving a unit conversion with a factor of 0 or less | Enter a factor above zero. | |
Unit "{unit}" for {item} has no approved conversion to {base}. Receive in {base}, or approve the conversion in Inventory › Unit conversions. | Receiving or booking a quantity in a unit with no approved conversion | Only approved conversions are used. | Approve the conversion, or use the base unit. |
Unit "{unit}" for {item} has no approved conversion to {base}. The approved pack is {pack}. | The unit text does not match the approved pack size | Use the approved pack text. | |
Qty must be greater than zero. | A converted quantity comes out at zero or less | Enter a larger quantity. | |
A lot enters stock through a goods receipt, so its Receipt movement and incoming inspection are recorded. Receive it in Inventory › Goods receipts (ISO 13485 7.5.8). | Adding a stock lot by hand | Stock is created by receiving. | Receive the goods. See Receive goods. |
A lot's {fields} cannot be edited directly. Use receiving, a stock movement, a stock count or a nonconforming stock disposition, so the change leaves a ledger entry (ISO 13485 7.5.8). | Editing a lot's quantity, status, bin, expiry, item or owner | Stock changes leave a ledger entry. | Use a stock movement or count. |
Product {key} rev {rev} is {status}. Start a new revision to change it. (or Production method, Work instruction) | Editing or deleting a product, method or work instruction that is not a Draft | A controlled document is read-only. | Start a new revision under an approved change note. See Change a released product. |
Approval signatures are written by the approval steps only. | Editing the approvals of a document | Only the approval buttons write them. | Use the buttons. |
The revision history is written by the revision steps only. | Editing the revision history | Use New revision. | |
The change note of a revision is written by the revision steps only. | Editing the change note field of a revision | Use New revision. | |
{record} already exists. | Saving a number that is taken | Numbers are unique. | Use another number. |
Build the bill of materials
Task page: Build the bill of materials.
| Message | When | What it means | What to do |
|---|---|---|---|
Product {key} rev {rev} is {status}. Start a new revision to change it. | Adding, editing or deleting a line of a product that is In review, Released or Obsolete | The bill follows its product. | Start a new revision. |
Production method {id} rev {rev} is {status}. Start a new revision to change it. | Changing a line that names a method that is not a Draft | The line is locked with its method. | Start a new revision of the method. |
Production method {id} is not a method of {product}. | Saving a line with a method of another product | Choose a method of this product, or leave it empty. | |
{record} already exists. | Two lines with the same number for the same product and method | Use the next free line number. |
Define the production method
Task page: Define the production method.
Saving the method and its lines
| Message | When | What it means | What to do |
|---|---|---|---|
Lot size from ({a}) cannot be above lot size to ({b}). | Saving a method with the lot range reversed | Swap or correct the two numbers. | |
Valid to ({b}) is before valid from ({a}). | Saving a method with the dates reversed | Correct the dates. | |
The product of a production method with a revision history cannot change. | Changing the Product of a method that has been released | Its kept release belongs to that product. | Leave the product. |
Production method {id} rev {rev} is {status}. Start a new revision to change it. | Editing a method, an operation, a line, an option or a parameter of a method that is not a Draft | Start a new revision. | |
{Label} must be a number. | Typing a non-number in Std time, First piece sample, IPQC every or IPQC sample | Use digits. | |
{Label} is not one of the options. | Choosing a value the field does not offer | Pick from the list. | |
{Label} {value} does not exist. | Naming a machine, work instruction or IPQC frequency that does not exist | Pick from the list. | |
Operation {n} of {method} was not found. | Editing, duplicating or removing an operation that was removed | Reload the method. | |
The operation number is not valid. | An operation request with a bad number | Reload the method. | |
Pick another production method to copy from. | Copy operations from… the same method | Choose a different method. | |
{method} has no operations | Copying from a method with no operations | Choose a method with operations. | |
The operations changed. Reload and try again. | Dragging an operation after another person changed the list | Reload and drag again. | |
Renumbering {method} would move rows of {product}, which is released: {rows} and {n} more. A new production method cannot change a released product. Revise the product or release a revision of the method through an engineering change first. | Reordering the operations of a new Draft method when lines or options of the released product name those operations | The product's own rows must not move. | Use the change process, or attach the rows to the method. |
Production method {id} was not found. / Machine option {key} was not found. | Editing something that was deleted | Reload. | |
First piece sample (pcs) must be a number. | Changing a machine option's first piece sample | Use digits. | |
Work instruction {id} does not exist. / IPQC frequency {id} does not exist. | Setting a machine option's work instruction or frequency | Pick from the list. |
Machine options
| Message | When | What it means | What to do |
|---|---|---|---|
{mould} is a mould, so the option needs a cycle above 0 seconds. | Saving an option with a mould and a cycle of 0 | A zero cycle gives an infinite rate. | Enter the cycle in seconds. |
Operation {n} is not an operation of production method {method}. | Saving an option for an operation the method does not have | Add the operation or correct the number. | |
Operation {n} is not an operation of any production method of {product}. | Saving an option with no method when no method of the product has that operation | Add the operation to a method. |
Process parameters
| Message | When | What it means | What to do |
|---|---|---|---|
The set value must sit inside the validated window. | Saving a parameter whose Set is outside Validated min and Validated max | Correct the set value or the window. | |
{product} already has a parameter "{name}" for this method, machine option and operation ({key}). Edit that one instead. | Saving a second parameter with the same name | One set point per parameter. | Edit the existing parameter. |
Submit for review and release
| Message | When | What it means | What to do |
|---|---|---|---|
Production method {id} rev {rev} has no operations. Add its operations before it is submitted. (or released) | Submit for review or the last approval on a method with no operation | Add operations. | |
Production method {id} rev {rev} has {n} operation{s} with gaps: op {n} {gap}, {gap}; op {n} {gap}. Fix them in the Draft before it is submitted. (or released) | Submit for review or the last approval | The gaps are no station, no work instruction, work instruction not released, no std time and no machine option. | Fix each operation. A work instruction must be Released. An Inactive machine option does not count. |
Write work instructions
Task page: Write work instructions.
| Message | When | What it means | What to do |
|---|---|---|---|
{doc} is in review, so its steps are read-only. Return it to draft to edit. | Editing steps in the studio while the work instruction is In review | Choose Return to draft on the record. | |
{doc} is obsolete and kept for history only. | Editing steps of an obsolete work instruction | Use the live revision. | |
Work instruction {doc} rev {rev} is released. Start a new revision to change it. | Editing steps of a released work instruction | Start a new revision. | |
Work instruction {doc} was not found. | Opening the studio for a work instruction that does not exist | Check the number. | |
Step {n} was not found. | Editing or moving a step that was removed | Reload the studio. | |
Confirmation is not one of the options. | Setting a confirmation that is not Tick, Scan or Enter value | Pick from the list. | |
A work instruction keeps at least one step. | Delete step on the last step | Add another step first, or leave it. | |
Link {doc} to an operation first, on the product's production method | Generate steps on a work instruction no operation names | There is nothing to draft from. | Set the work instruction on an operation. |
The system finds a setup guide by its mould, not by an operation: {doc} is for mould {mould}. Write its steps by hand. | Generate steps on a setup guide (SG-M307 for mould M-307) | A setup guide is tied to its mould by its number, not to an operation. | Name the guide after the mould and type its steps. |
Work instruction {doc} rev {rev} has no steps. Add at least one step before it is submitted for review. (or released) | Submit for review or the last approval | Add a step. |
Set the inspection plan
Task page: Set the inspection plan.
| Message | When | What it means | What to do |
|---|---|---|---|
Tolerance must be greater than zero. | Saving a characteristic with ± Tol of 0 or less | The limits would be a single point. | Enter a tolerance above zero. |
Product {key} rev {rev} is {status}. Start a new revision to change it. | Adding, editing or deleting a characteristic of a product that is not a Draft | The plan follows its product. | Start a new revision. |
Production method {id} rev {rev} is {status}. Start a new revision to change it. | The same, for a characteristic that names a method that is not a Draft | Start a new revision of the method. | |
Production method {id} is not a method of {product}. | Naming a method of another product | Pick the product's method. |
Validate the process
Task page: Validate the process.
Process FMEA
| Message | When | What it means | What to do |
|---|---|---|---|
Score severity, occurrence and detection (1–10) | Score · set priority with S, O or D blank | Choose 1 to 10 for all three. | |
Enter the owner, Enter the due date, Enter the recommended action and owner, or Enter the recommended action, owner and due date | Start action with the named items blank | The message names only what is empty. | Fill in the recommended action, the owner and the due date. |
Re-score S, O and D after the action | Re-score · close with S after, O after or D after blank | Fill in all three. | |
Severity can only drop through a design change. Keep S at {S} or record the design change in the action. | Re-score · close with a lower severity and no design change in the action | Keep S, or write the design change in Recommended action. | |
Occurrence or detection must be reduced by the action (O×D now {n}). | Re-score · close where O after × D after is not lower | The action did not reduce the risk. | Re-score honestly, or carry out a further action. |
Still High priority after action (RPN {rpn}, S {s} with O {o}). Reduce occurrence below 3 or add a further action. | Re-score · close where the line is still High | Add a further action. |
Process validation
| Message | When | What it means | What to do |
|---|---|---|---|
Fill in first: process, scope, trigger, protocol, validated parameters, acceptance criteria, PQ lots / samples (only the blank ones) | Approve protocol | The protocol is not complete. | Fill in the named fields. |
Link the engineering change note | Approve protocol when the trigger is Engineering change note and none is linked | Select the change note in Engineering change note. | |
The approver must be someone other than the preparer | Approve protocol or Approve · validated by the Prepared by person | Independent approval. | Ask another QA engineer. |
Fill in first: results, IQ, OQ (IQ and OQ only when the scope includes them; only the blank ones) | Submit report | Fill in the named fields. | |
PQ readings: {problem}; {problem}. Enter the PQ readings first. (up to three problems) where a problem is {characteristic} is on {n} of {lots} lots, {characteristic} lot {lot} has {n} of {readings} readings, {characteristic} lot {lot} has no spread in its readings, {characteristic} lot {lot} is entered twice or No PQ readings ({lots} lots of {readings}) (the numbers that your organization sets; default 3 lots of 30) | Submit report or Approve · validated for a scope with PQ | The readings are too few to judge capability. | Enter more readings in the PQ readings panel while Executing. |
PQ readings are not valid (row {n}): {reason} where the reason is Enter the lot, Enter the characteristic, Enter at least one limit (LSL or USL), The lower limit must be below the upper limit, or must be a number | Save readings | A row is incomplete. | Fix the row named. |
PQ lot {lot} is not a lot made by a validation run of {validation}. | Save readings with a lot that is typed, or made by an ordinary order or another validation | The readings must come from real lots. | Make the lots with a validation run, see Validate the process, and name them. |
PQ readings can only be entered while the validation is Executing. | Save readings in any other status | Choose Start execution first. | |
Min. Cpk is calculated from the PQ readings when the report is submitted. | Typing or changing Min. Cpk | The number comes from the readings. | Leave the field; submit the report. |
Fill in first: revalidation period | Approve · validated with Revalidate every (months) blank | Enter the months. | |
Min. Cpk {x} is below 1.33. Fail the validation or record a justified deviation and re-run. | Approve · validated with Cpk under 1.33 | The process is not capable enough. | Choose Fail, or improve the process and revalidate. |
Fill in first: deviations (reason for failure) | Fail with Deviations blank | Describe why it failed. | |
{open} is already open as the revalidation of {base}. Finish it first. | Start revalidation while one is open | Open the revalidation that exists. |
Release the product documents
Task page: Release the product documents.
Submit for review and the last approval
| Message | When | What it means | What to do |
|---|---|---|---|
Product {pn} rev {rev} cannot be submitted: its medical device file lacks {gaps}. Complete the file first (a routing must be Released before its product is). (or released) where gaps are BOM, released routing, production method, work instruction, PFMEA (or PFMEA (no scored line; unscored: {lines}), which names the lines to score) | Submit for review, or the last approval, of a product | The product's file does not have an item that the product release requirements require. | Add the missing piece. Release the method first. An Org admin can change the requirements. |
The method messages and Work instruction {doc} rev {rev} has no steps... | Submit for review, or the last approval, of a method or work instruction | See Define the production method and Write work instructions. |
Approval levels
| Message | When | What it means | What to do |
|---|---|---|---|
{Level} must be signed by {role} for example Production review must be signed by Production supervisor | Pressing Approve · Level n of m · name without the level's authority (the button is normally greyed out with This step needs a {role} signature) | Each level has an owner. When levels sign in any order, no open level is yours: the message names the first open level, and the greyed-out button names every open role (This step needs a Production supervisor or QA manager signature). | Ask the person who holds one of those roles, or a person they delegated to. |
The same person cannot sign two levels | Signing a second level of one revision | Ask a different person. | |
Every approval level is signed. Return it to draft and submit it again. | Approving a document whose levels are all signed | Return it to draft if it needs to go round again. | |
That action is not available while the record is {status}. | Signing a level of a document that is not In review | Reload the document. |
New revision and make obsolete
| Message | When | What it means | What to do |
|---|---|---|---|
A new revision needs an approved engineering change note | New revision with no approved change note chosen, or a note that does not list or cover the document | Every revision is made under a change note. | Raise or choose an approved note. See Change a released product. |
{key} is still in use and cannot be made obsolete. {group}: {keys} and {n} more. {advice} where groups are Manufacturing orders, Sales orders, Quotations, Manufacturing orders running it, Machine options, Operations, Machines, PM plans | Make obsolete while records use the document | Withdrawing it would strand work. | Follow the advice: for a product Close, cancel or move them to another product first., for a method Finish or cancel them first., for a work instruction Pick its replacement on each first. |
Print a controlled copy
| Message | When | What it means | What to do |
|---|---|---|---|
{key} has no released revision to print. Release it first. | Print or save as PDF on a document that was never released | A copy shows a released revision, never a Draft. | Release the document. |
{key} is obsolete and has no released revision to print. | Print or save as PDF on an obsolete document | Nothing is in force. | None. Use the replacement document. |
{key} rev {B} is being revised; print the released rev {A} from its revision history, or release rev {B} first. | Print or save as PDF while a new revision is a Draft or In review | The sheet prints the record as it stands, which is not released. | Release the new revision, then print. |
See Controlled copies follow the release.
Return to draft
Return to draft has no content check. It clears the approvals.
QMS documents
| Message | When | What it means | What to do |
|---|---|---|---|
Fill in first: owner, approver, change description, distribution roles (only the blank ones) | Submit for review | Fill in the named fields. | |
Choose the roles that must read this document. | Submit for review or approve with no distribution roles | Choose roles. | |
The distribution names a role that does not exist: {roles}. Choose roles from the list, or All roles. (plural: roles that do not exist) | Same | Pick from the list. | |
All roles stands for every role, so it cannot be listed beside other roles. Choose All roles on its own, or name the roles. | Same | Choose All roles alone. | |
Assign an approver first | Approving with no approver | Assign an approver while it is a draft. | |
The approver must be someone other than the owner ({name}) | The owner tries to approve, or the owner is named as approver | Independent approval. | Name another approver. |
Only {name} can approve this revision | Approving as someone other than the named approver | Ask the named person. | |
The approver must be someone other than the person who submitted this revision ({name}) | The submitter tries to approve | Ask the approver. | |
The approver must be someone who did not write this revision. You created, edited or submitted it | A person who edited the revision tries to approve | Ask another approver. | |
Return to draft and submit again: this revision was submitted before the system recorded who submitted it, so independent approval cannot be shown | Approving an older submission | Return it to draft and submit again. | |
You cannot name yourself as the approver of a document you are editing. Ask the document owner or QA to assign another approver. | Naming yourself as approver | Ask someone else to assign one. | |
{Field} cannot be changed while the revision is in review. Return it to draft first. | Editing a fixed field in review | Choose Return to draft. | |
The document file can only change while the revision is a draft. Return it to draft or start a new revision first. | Attaching or removing the file outside a draft | Return it to draft. | |
Sign in as a named user to acknowledge | Acknowledge read by an account with no employee record | Sign in with a named account. | |
{doc} is not distributed to {role}, so you do not read and sign it. Ask the QA manager to add the role to its distribution. | Acknowledge read by a role not on the distribution | Ask the QA manager. | |
A manager judged you not yet competent on {doc} rev {rev}; ask for retraining. | Acknowledge read after a not-competent judgement | Ask for retraining. | |
Your training on {doc} rev {rev} is waiting for the QA manager's effectiveness check; reading again does not replace it. | Acknowledge read while that check is pending | Wait for the check. |
QMS document messages for Periodic review · no change, Start revision and Make obsolete are not listed here.