Corrective Action Request (CAPA)

From problem to closure on two pages: containment, a 5-Why root cause with cause categories, corrective and preventive actions with owners and dates, and the effectiveness check.

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Corrective Action Request (CAPA): infographic with a sketch of the document, when to use it, common mistakes and the country versions.
2 tables, 3 signatures.

Country versions

  • International
  • Korea *
  • Japan *
  • Germany *

* check with local advice

A template, not advice.

Read more

What it is

A corrective and preventive action request (CAPA) is the record of how a problem is understood, fixed and kept from coming back. A corrective action deals with a problem that has already happened; a preventive action deals with one that could happen. Both follow the same path: describe the problem, contain it, find the root cause, decide actions with owners and dates, and check later that the actions really worked before closing.

The sheet follows that path in six numbered parts. The containment part, what you did at once, is hidden when the request is only about a possible problem. The root-cause part has a five-row "why" table and the usual cause categories (people, machine, method, material, measurement, environment) to tick. The action table separates corrective from preventive actions, with owner, due date and a done tick, and works out how many are finished and the percentage complete. The date of the effectiveness check is calculated from the day all actions were completed plus the number of days you choose. The wording is what ISO 9001-style systems commonly use; the sheet is a general template and does not by itself make a record audit-ready.

When to use it
  • An NCR, a complaint or an audit finding needs a real fix, not only a clean-up of the goods.
  • The same problem has appeared more than once.
  • A customer or auditor asks for the root cause and the actions taken.
  • You see a risk and want preventive action on record before anything goes wrong.
How to fill it in
  1. Number the request, say who raised it and who owns it, and enter the NCR number if there is one.
  2. Describe the problem with facts, and record what you did at once to contain it.
  3. Ask "why" until you reach a cause you can remove, tick the cause categories and write the root cause in one sentence.
  4. Ask whether the same weakness exists elsewhere, and say what you will do about it.
  5. List the actions with type, owner and due date, and tick "done" with the date as each is finished.
  6. Say how you will know it worked, and enter the day all actions were completed; the check date follows from it.
  7. Record the result of the check, then close the request with the approver's name and the date.
Common mistakes
  • Stopping at the first "because": a symptom or a person's slip, not the reason the process allowed it.
  • Writing blame ("careless operator") instead of the gap in the process.
  • Listing actions with no owner or no date, so nobody answers for them.
  • Counting "retrain the operator" as a lasting fix when nothing in the process changes.
  • Closing as soon as the actions are done, without checking that the problem has really stopped.
  • Setting a vague effectiveness criterion ("looks better") instead of a measure and a period.
Steps at a glance
  1. Fill in
  2. Check the preview
  3. Save as PDF, Word or Excel
Country versions

Pick the country you need. Each version uses the wording and layout commonly found there; a version marked “check with local advice” should be read by someone who knows the local rules before it is used.

  • International (XX): Written in English, Korean, Japanese, German
  • Korea (KR): Written in Korean, English – check with local advice
  • Japan (JP): Written in Japanese, English – check with local advice
  • Germany (DE): Written in German, English – check with local advice

Designs

The same form in several designs. The fields and the wording stay the same; only the look changes.

  • Boxed form
  • Ledger
  • Compact
  • Banner
  • Warm
  • Plain (black and white)
  • Modern
  • Formal
  • Side band
  • Classic
  • Minimal
  • Executive

Your details fill it in

Fields that ask for your name, address or company details are filled from My details, so you do not type them again; you can still change any field for one form. Signed in, your details stay in your account; otherwise they stay in this browser only. A passport, identity or social security number is never saved.

Questions

What is the difference between a correction, a corrective action and a preventive action?
A correction fixes the thing in front of you, for example reworking the batch. A corrective action removes the cause so the problem does not return. A preventive action removes the cause of a problem that has not happened yet. On this sheet the containment part is the correction, and the action table holds the other two.
How many whys do I need?
Five is a rule of thumb, not a requirement. Stop when you reach a cause you can act on and that, once removed, would have prevented the problem. Sometimes three are enough; sometimes the chain branches and you need a second sheet.
Is this an 8D report?
No. It covers similar ground (containment, root cause, corrective action, prevention), but a customer's 8D format has its own steps and wording. If a customer asks for its format, use that and keep this sheet as your internal record.
How is the date of the effectiveness check worked out?
It is the day all actions were completed plus the number of days you set, 30 by default. Change the days to fit the problem: a rare event may need a longer observation period.
Does filling in a CAPA make us compliant?
No. QuoteBill forms are general templates, not legal, regulatory or audit advice. Whether your system meets a standard or a regulator's expectations depends on the whole system, not on one record.
Is this form legal, tax or accounting advice?
No. It is a template: it gives you the usual structure and wording, not advice. Rules differ by country and case, so have someone qualified read anything that matters before you sign, send or file it.
Which countries and designs does it come in?
It comes in 4 country versions: International, Korea, Japan, and Germany. 12 designs.

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A form is a template, not legal, tax or accounting advice. Rules differ by country and case.