Complaints Essentials
A complaint is different from every other quality record you will meet, for one reason: the product is already out of your control. Someone else has it, and they may be a patient.
Taking the complaint properly, deciding whether it is a quality defect, investigating backwards from an effect somebody else noticed, notifying the right people in time, and learning from what the customer found before you did.
Five things you will take back to site
One outcome per lesson. Each is practised in the lesson and tested at the end of it.
- Know what a complaint is and who owns itRecognise a quality complaint, keep it independent of sales, and get it into a system that acts without delay.
- Take it so that it can be investigatedCapture the first record properly, because everything that follows is linked back to it.
- Decide whether it is a quality defectApply a four-question test, decide on risk, and act to reduce risk before all the facts are in when clause 8.14 requires it.
- Investigate backwardsWork from an effect the customer saw to a cause on your site, months after the batch was made, using retained samples and batch records.
- Close, reply and learnReply to the customer, notify the marketing authorisation holder and authorities where required, and trend complaints so the system improves.
Structured so that it stays with you
Short courses are usually forgotten within a month. This one is built around the few things that are known to make material stay: hearing it as well as reading it, being asked to recall it, and meeting the same ideas again in a different form.
Narrated throughout
Every topic is narrated, so you can listen and read together, or listen alone. Hearing and reading the same material is one of the simplest ways to make it stay.
Orientation in thirty seconds
Each topic opens with the whole argument in four lines. You know where you are going before you start, which is when new material is easiest to place.
Pause and answer
Every topic stops once and asks you a question about what you have just read, with feedback either way. Recalling something is what fixes it; re-reading it is not.
Three things to remember
Each topic ends with three sentences. Not a summary of everything, but the three things you would want back in six months.
A check at the end of every lesson
Three questions per lesson, then a twenty-question final assessment. Every question is answerable from the three things to remember. Nothing is tested that was not taught.
One case, worked through
A workshop that gives you a real situation and four decisions to make in writing, before you see how an experienced person would handle it.
Five lessons, in the order the work happens
Each lesson has three narrated topics and ends with a three-question knowledge check. After Lesson 5 comes the workshop, the final assessment, the job aids, and a short page on what to do in the next few weeks.
| Lesson | Title | What it covers | Basis in EudraLex Volume 4 |
|---|---|---|---|
| 1 | What a complaint is | Independence, resources, and why no delay. | Chapter 8, 8.1 to 8.5, 8.7 |
| 2 | Taking the complaint | The first record, and what it has to hold. | Chapter 8, 8.5, 8.12 |
| 3 | Is it a quality defect? | The four-question test, risk, and acting without full information. | Chapter 8, 8.1, 8.5, 8.13 to 8.15 |
| 4 | Investigating | Working backwards from the effect; cause and CAPA. | Chapter 8, 8.12, 8.16 to 8.18 |
| 5 | Closing and learning | The reply, closing the record, and the trend. | Chapter 8, 8.1, 8.12, 8.19 |
Who this course is for
Anyone who might take a complaint call, log a complaint, investigate one, or sign one off. Customer service, QC, production and QA. It assumes you work on a GMP site or for a marketing authorisation holder.
Where it sits in EU GMP
The first half of Chapter 8. Clauses 8.1 to 8.7 cover personnel, independence and handling; 8.10 to 8.15 cover recording, scope, assessment, risk-based decisions and notification; 8.16 to 8.19 cover investigation, root cause, CAPA and trending. The companion course, Product Recall Essentials, covers the second half.
Basis
EudraLex Volume 4, Chapter 8, clauses 8.1 to 8.19
If you want the whole subject in an afternoon, and to still have it in six months, this is the course to start with.
Enrolment gives access to all five lessons, the narrated topics, the workshop, the final assessment and the printable job aids. Work through it at your own pace; your progress is saved.
