Manufacturing
Change control in production
Changing a supplier, a parameter or a machine, without it becoming an audit finding.
In any regulated manufacturing, change is not the problem: the problem is the change that happened with no record that anyone assessed it. An auditor will not fault you for changing an excipient supplier; they will ask who assessed the impact and against what criteria.
The changes that slip through
| Change | Why it slips | What should have remained |
|---|---|---|
| A raw material supplier | Purchasing decides on lead time or price | Impact assessment and approval |
| A parameter adjustment | Done on the floor and it works better | Justification and who authorised it |
| A repair with a different part | The original was not arriving in time | Equivalence and later verification |
| A software or version change | Done by maintenance or IT | Impact on records and validations |
Important
The fourth row grows fastest and is least treated as a process change. An equipment or software update can alter how data is recorded, and that affects validation even though the machine still does the same thing.
What a change record must contain
- 1
What is changing and why
In one line understandable by someone who was not there.
- 2
What impact it may have and on what
Product, process, records, validations, other areas.
- 3
Who approves it
With a name and a date; an approval without an author is not an approval.
- 4
And how it is verified afterwards
Later verification is what closes the change; without it, it stays open.
Watch out
The usual error is not doing the record badly: it is doing it afterwards. Change control signed three weeks later, with production already run, assesses nothing — it documents a decision already taken, and it shows.
How to sustain it without slowing the plant
Without a fast lane, people bypass the process to get work done, and then you do not have a strict system: you have a system that is not followed. A light procedure that is followed beats a perfect one that is dodged.
Worth knowing
The same approach suits medical devices, cosmetics, certified food schemes and automotive: the reference standard and threshold change, not the logic of assessing before and verifying after.
›What about emergency changes?
Do them and document immediately after, with that condition stated.
›Is it needed for a packaging supplier change?
If it touches the product or its preservation, yes. It is among the most underestimated.
›Who should approve?
Whoever answers for product quality, not whoever makes the change.
A real case
The situation
A plant changes a component supplier because of lead times.
What you do
- Records the change with impact and approval before using it
- Verifies the first batch made with the new one
What you get
The audit finds the change assessed and closed, instead of a finding.
The situation
Something changes and is documented weeks later.
What you do
- Records the change before applying it
What you get
The file describes what is done.
The situation
Nobody knows from which batch a change applies.
What you do
- Records from which unit it takes effect
What you get
You can say what each batch carried.
The situation
A change affects documentation nobody reviews.
What you do
- Reviews which documents describe what changes
What you get
The papers keep describing the product.
The situation
The client asks to be told of any change.
What you do
- Records what was communicated and when
What you get
The commitment is demonstrable.
The situation
A review asks about an old change.
What you do
- Keeps the change history with its dates
What you get
You answer from the record.
This article answers
- documented change control
- changing a validated supplier
- modifying a production process paperwork
- change management in manufacturing