Quality is a function, not a final check.

It is led independently and built in from the first experiment.

Technician in protective clothing holding a sample tube

Commitments

Four habits.

Documented

Procedures, batch records and deviations are written down and reviewed.

Traceable

Source, process and test data are linked to every lot.

Independent

Quality has its own leadership, apart from process and technical teams.

Improving

Findings feed back into methods and training.

One lot, one linked record

1SourceOrigin recorded

2ProcessConditions logged

3TestResults attached

4ReleaseReviewed by Quality

5RecordKept and traceable

Every stage adds to the same record, so any lot can be traced back to its source.

Systems

Built for scale.

The quality framework is designed around GMP principles, so work done in research can be carried into regulated manufacturing without being redone.

Certificates and approvals are listed only when they are held. Ask for the current position at any time.

Analytical instrument on a laboratory bench

Questions

Common questions.

Who is responsible for quality?

A Director of Quality leads the function independently of process and technical teams.

Can you complete a supplier questionnaire?

Yes. Send it to us and the Director of Quality will respond with the current position on documentation and systems.

Do you hold quality certifications?

We list certificates and approvals only when they are held. Ask for the current position at any time.

Records

The documents behind every lot.

DocumentPurpose

SpecificationWhat the material must be

Batch recordWhat was done, step by step

Certificate of analysisWhat was measured, and the results

Deviation logAnything that departed from procedure, and what was done

Change recordAny change to methods or materials, and why

Handling a deviation

1DetectAnyone can raise it

2RecordWritten down at once

3InvestigateCause established

4CorrectAction taken

5ReviewQuality signs off

Every departure from procedure follows the same path.

Data integrity

Five habits of reliable records.

Attributable

Who did it, and when.

Legible

Readable now and later.

Contemporaneous

Recorded at the time.

Original

The first record is kept.

Accurate

It reflects what happened.

Audits

Ready to be questioned.

What an auditor can expect

Procedures that match practice
Records that are complete and traceable
People who can explain what they do

What we expect of ourselves

Findings recorded and acted on
Methods improved when they fall short
Honest answers about status

Across the life of a lot

Quality from first sample to last record.

Quality begins before a lot exists, with specifications that say what good looks like. It continues through production, where records show what was done, and through testing, where results show what was achieved.

At release, the quality function reviews the whole record. If something does not match, the lot is held until the reason is understood.

Release

How a lot is released.

Specification

What the lot must be is written first.

Production record

What was done is recorded step by step.

Testing

Results are compared with the specification.

Review

Quality reads the whole record before release.

Supplier questionnaire?

Our Director of Quality can discuss documentation, audits and supplier questions.