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Questionnaire

Fifteen questions about your packaging file, scored in your browser.

Answer fifteen questions a quality or regulatory director can settle from memory or from one look at the file. In about four minutes you know how much of your ISO 11607 packaging evidence is written down, how much is still living in people's heads, and where the open items cluster. All four result bands are published below, so you read what a count means before you make one.

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In short

What a packaging validation readiness questionnaire is

A packaging validation readiness questionnaire is a self assessment. Fifteen generic questions ask what an ISO 11607 packaging file contains and whether each part is written down. The answers produce a count of open items and a band. Scoring runs in the browser, the answers stay in the browser, and every band is published on the page rather than generated for you.

Before you start

How to answer it, and where the answers go.

It takes about four minutes, and it is built to be answered honestly rather than carefully: the count is only worth something if it reflects what is in the file today, not what you are hoping is there. Answer from memory or from one look, and where you are not sure, say so.

Answer from memory, or from one look

Every question can be settled by knowing your own file or by opening it once. If a question would send you off to run a test, it is the wrong question and it is not on this list.

"I would have to check" is a real answer

It counts as an open item, and it should. An item nobody in the building can confirm from memory is an item somebody has to go and find, and that is time whether the answer turns out to be yes or no.

The answers stay in this browser

The counting runs on this page, in your browser. What you tick is held in this tab, reaches no server and is written to no log. The summary you download at the end carries your answers to your own machine, and nothing goes anywhere else.

The summary is yours to keep

Download it as a plain text file with your own answers on it, put it in your own files, and take it into whatever internal conversation it is useful in. It is generated on this page and it goes to your machine.

The questionnaire

Answer the fifteen, and get your count.

Answer all fifteen and you see how much of your file is settled, how much you would have to go and check, and where the open items sit across the six areas. Every question carries the same three answers, so the count means the same thing wherever it comes from.

Everything below is scored in this browser. What you tick stays in this tab, reaches no server and is written to no log.

Scope, standards and editions

What your file says it is written against, and whether that is still the edition anyone else would expect to see.

  1. Your packaging file names the standards it is written against, and names them in the file rather than in somebody's head.
  2. For each standard your file cites, you can say which edition, and where an FDA recognition number exists for that edition, which one.

    Not every standard a packaging file cites carries a recognition number. Knowing which of yours do is the answerable part.

  3. Your declaration of conformity position is written down, and you know which edition of ISO 11607-1 it points at.

    Relevant to premarket submissions filed after 20 December 2026, which is a documentation question rather than a reason to revalidate a device already on the market.

The risk management linkage

Whether the packaging file and the risk management file can be read together by somebody who was not in the room.

  1. A reader can get from a packaging decision in your file to the related part of your ISO 14971 risk management file by following a written reference.
  2. The packaging hazards recorded in that risk file are specific to this packaging system, rather than written at the level of packaging in general.
The sterile barrier system, and the evidence about it

What has actually been measured on the barrier, and whether the methods that measured it have a position of their own.

  1. Seal strength has been measured on packages made by the sealing process you will ship with, rather than only on a development build.
  2. Package integrity is evidenced separately from seal strength, by a method chosen for this package format.

    Seal integrity and package integrity are different claims and are not shown by the same test. The glossary sets out the distinction.

  3. Every test method your file relies on has a documented validation position, and the file says whose position it is.

    A method validated by the laboratory that runs it is a different record from a method nobody has validated at all. Either can be fine. Silence is the finding.

Stability, the aging branch

The basis for the aging, and whether the real time study that confirms it is actually running.

  1. The aging basis is written down: the claim in days, the chamber temperature, the ambient reference and the Q10, each with where it came from.

    The arithmetic and a worked example are on the accelerated aging calculator page if you want to check yours against it.

  2. A real time study is running from the same build as the accelerated one, and its start date is recorded.
Distribution, the performance branch

Whether the shipping evidence describes how the product actually ships, and whether the arrangement of the arms is on the record.

  1. The distribution profile your testing uses matches how the product actually ships, and the basis for choosing it is recorded.
  2. However your distribution and aging arms are arranged, the arrangement and the reason for it are written down.

    Transit first, aging first, and the two combined into one arm are all defensible and no order is mandated. What gets asked about is the reasoning, not the order.

The process side, and the record around it

ISO 11607-2 covers the process that makes the barrier. This area is where a file is most often complete on the package and silent on the process.

  1. The forming and sealing process is validated at the site that runs it, and you hold those qualification records or can get them.

    Including where the sealing happens at a contract manufacturer rather than at your own site.

  2. Your sample sizes and acceptance criteria carry a written basis, and the criteria were set before the results existed.
  3. There is a change control path that says which packaging changes trigger revalidation, and it names who decides.

Your count

Your open items, and the band they land in.

Settled
0
To check
0
Not yet
0
Open items
0 of 15

Band

The bands are defined over all fifteen answers. Until every question has one, the counts are shown and the band is left blank rather than guessed at from a part of the set.

A plain text file with the fifteen questions, the answers you gave, the counts and the band, generated on this page and saved to your machine.

The bands

What each result means, and the count behind it.

Read all four before you start, so you know what each result means and what it points you toward next. Your band is set by the open item count and by nothing else, which is why you can check it against the arithmetic yourself.

Nothing indicated

0 open items of 15

Every question on this instrument is settled and written down. On what fifteen generic questions can see, which is your answers and not your file, there is nothing here to act on. That is a real result and it is the one this page was written to be able to give.

A short list

1 to 3 open items of 15

A count in this range describes a file whose structure is in place with a small number of items open. What decides the cost of closing them is whether each one is a document to write or a test to run, and that is a distinction worth making before anything is scheduled.

A working list

4 to 8 open items of 15

A count in this range describes open items in more than one area at once. Order matters more than the count here: anything that needs something run carries a lead time that document work does not, and accelerated aging in particular is fixed by arithmetic rather than by how the work is resourced.

An early file

9 to 15 open items of 15

A count in this range describes a file early in its life, or one where the record lives in people rather than in documents. That is an ordinary place to be standing before a validation program starts, and it is a better place to be standing than a file that looks complete and is not.

The scoring

How the count is made, in five lines.

Published so the result can be checked rather than trusted, and so the same count can be arrived at on paper by anyone who wants to.

01Count the settled answers

Every question answered "Yes, and it is written down" is settled. This number is shown, and it decides nothing.

02Count the ones to check

Every question answered "I would have to check" is a to-check item.

03Count the ones not yet done

Every question answered "Not yet" is a not-yet item.

04Add the last two together

Open items are the to-check count plus the not-yet count. There is no weighting between them: an item nobody can confirm and an item nobody has started both need somebody to go and do something, and which of the two is worse depends on facts this instrument cannot see.

05Read the band off the open item count

The four ranges are published above. Nothing else enters the band: not which areas the open items are in, not the order they were answered in, and not anything about your device.

Two things follow from the arithmetic being this plain. A count of 15 out of 15 settled is reachable, and it is meant to be. And because the areas carry no weights, the count says how much is open rather than how serious it is. Seriousness is a judgment about a specific file, and that is the thing this page deliberately does not do.

Where this stops

What the result is, and what it is worth.

It is a questionnaire, and it is not a declaration

The result is a count of answers given by one person on a web page. It binds nobody, it records nothing about your organization, and it is not a compliance statement of any kind. Anyone using it as one has taken it somewhere it was never able to go.

It reads your answers, not your file

Fifteen questions can see what you tell them. Whether the document you are thinking of actually says what you remember it saying is the difference between this page and a reading of the file itself.

The band applies judgment to a count, not to your device

Every band above describes what a number means. None of them describes your product, your packaging system or your submission, and no version of this page will.

It is generic on purpose

The same fifteen questions go to everyone. That is what makes the result yours rather than ours, and it is also the ceiling on what it can tell you.

What is missing, and why

Four questions this instrument does not ask.

Every question here can be answered without anyone reading a standard. Questions that would need one are absent, and the reason is worth publishing rather than hiding.

ISO 11607-1, ISO 11607-2 and Amendment 1:2023 are paid documents. They have not been bought for this project and no clause of any of them has been read here, so this page states no requirement of theirs. That rules out four kinds of question: anything of the form "does your file meet clause X", anything asserting what Amendment 1:2023 requires, anything asking whether a named test is required for a named package format, and anything with a mandated test sequence inside it. Question 04 asks only whether a written reference exists between two of your own documents, which is a fact about your file and needs no standard to ask about. Question 12 passes equally whether your transit arm runs before your aging arm, after it, or combined with it, because ASTM F1980 section 1.5 puts distribution outside the aging guide's scope and mandates no order.

How this site sources what it publishes, and what happens when a citation turns out to be second-hand, is set out on the methodology page.

Next

The same questions, asked of the file itself.

Where this page reads fifteen answers, the Packaging Standards Gap Assessment reads the documents: a clause by clause conformity matrix, every finding graded by what it costs to close, and a prioritized plan. It is $2,500 fixed, and a possible finding is that you have no gap and need nothing.

Packaging Standards Gap AssessmentBook a 30-minute call