You already know what's wrong. The question is what to fix first.
Established manufacturing operations rarely have a mystery on their hands. They have a list, and no time, and a system that was built for a smaller version of the company.
I work with pharmaceutical manufacturers on the quality system underneath all of it: what's causing the repeat findings, what's slowing everything down, and what can be taken out.
28 years in life sciences across three continents
Experience with USFDA, TGA and MHRA audits
What I hear from manufacturers
The same findings turn up every audit cycle
Systems built years ago that nobody has unpicked since
Quality has become the bottleneck for everything
Volume is scaling faster than the system was designed for
Suppliers assessed inconsistently, or on a questionnaire and nothing else
Records that take days to assemble when someone asks
Why these things persist in manufacturing specifically
Production never stops long enough to fix anything. Every improvement competes directly with output, and output usually wins. That's not a failure of will, it's the structure of the business.
A control can become the problem
Every finding added a control and none were removed. Over enough cycles the accumulated weight becomes the problem rather than the solution. I've seen a site where every mat change outside a processing room had to be logged. No regulation required it, nobody knew when it started, and the result was that the mats stopped being changed at all.
The people who built the system have moved on.
Nobody remembers why half of it exists, so nobody feels able to change it.
Improvement competes with output.
The quality improvement that would save four hours a week never gets the two days it needs.
Where manufacturers usually are when they call
Established but overloaded.
The system works, technically. It's just consuming more than it returns.
Growing past the system.
What was fine at one product and one shift isn't fine now.
Remediating after findings.
An inspection or a customer audit produced something that has to be addressed properly.
Preparing for scrutiny.
A date, a new customer, or a partner about to look closely.
What tends to help
Design and implementation of tailored quality systems
When the system itself is the constraint.
GxP compliance assessments
When you want an honest read before deciding anything, or you have a date coming.
Audit support
When your internal audits stopped telling you anything new, or you need suppliers assessed properly.
How I work
01 / 03
Understand the operation before changing anything.
02 / 03
Take out what isn't doing work, or isn't compliant.
03 / 03
Implement, then verify against the requirements.
Proof
After a TGA finding — multi-product medicines manufacturer
Systems in place for over twenty years, and a TGA audit that found major gaps in the rationale behind them. Staff couldn't understand why arrangements accepted for years were suddenly non-compliant, QA and operations disagreed about how the controls should be implemented, and everyone was overwhelmed by the volume of work the findings created.
I reviewed the finding and the documents behind it, walked the facility to see where implementation differed from procedure, and interviewed staff about what they understood and what was getting in their way. Every finding came with the reasoning: why this specific thing would concern an inspector.
Batch release, unblocked — contract development and manufacturing organisation
Final batch review and release had become the bottleneck for project delivery. Slow documentation review, the same minor gaps recurring, and QA and production working from different understandings of what compliance required.
Process mapping and a joint session with both groups surfaced duplicated activities and real logistical constraints. Redundant steps came out, target timelines went in for each stage, and the project deliverable timeline was met.
eQMS effectiveness review — pharmaceutical CDMO
An electronic quality system implemented fast during the pandemic, with manual workarounds running alongside it and serious data integrity consequences. The gaps were found before an inspector found them.
CLIENT PERSPECTIVE
"What stood out most was the ability to translate complex GMP requirements into clear, actionable recommendations that were meaningful for both Quality and Operations."
Shalin Parikh, Head of Quality, Mayne Pharma
Questions manufacturers ask
Can our existing systems be improved, or do they need replacing?
Improved, almost always. Replacing a working-but-heavy system is expensive and rarely necessary.
Why do the same findings keep returning?
Usually because the fix addressed the finding rather than what made it possible. That's a system question, not a CAPA question.
How do we scale quality as volume grows?
By making the system lighter rather than adding to it. Most systems break at scale because they were already carrying more than they needed.
Can you work alongside our QA team?
Yes. I work inside existing teams. Your QA people usually know where the problems are already.
Do you work with contract manufacturers and their clients?
Yes, on both sides of that relationship.
Can you audit our suppliers?
Yes, in Australia and overseas. I've audited API manufacture, sterile fill-finish, contract testing laboratories, IMP storage and sterilisation facilities. Audit support →
