GMP audits

GMP audits that test what HACCP assumes

A good manufacturing practice audit checks the operating conditions that make safe production possible: building fabric, services, equipment, maintenance, cleaning, personal hygiene, storage, product flow and contamination control. ASC audits your site against R638 and recognised prerequisite requirements, generally in one day, and reports within a week. ASC is not a certification body.

Auditing is charged hourly and a full programme is quoted on scope once ASC has seen the site. ASC will tell you before the quote if the work is smaller than you think.

One dayTypical GMP audit on site
One weekWritten report after the audit
R638The hygiene law your premises answer to
SAATCA, Exemplar Global, IRCA registered lead auditorsFoodBev SETA Accredited Provider No. 587/00337/1900Gqeberha, Johannesburg, Cape Town and Durban
Talk to ASC, or start with the documentsWhatsApp ASCRequest a quoteGMP and PRP toolkits
Audited to ISO 19011Findings rest on evidence rather than opinion, written so a certification body auditor could read the report cold and follow it.
Led by a working lead auditorThe person auditing your site is a lead auditor registered with SAATCA, Exemplar Global and IRCA who audits to these standards for a living, so a finding is graded at the severity its consequence justifies.
You are told the truth about the dateWhere a customer deadline is not achievable, ASC says so before the quote rather than after the audit.

Good manufacturing practice is the set of operating conditions and daily practices that make consistently safe production possible. Most people hear the term and picture cleaning schedules and hairnets. That is a small corner of it. GMP is the building fabric and its maintenance, the direction air, water and effluent travel, whether equipment can be dismantled and cleaned, whether the repair becomes the contamination, and how material moves from receiving to dispatch without crossing what it should not.

This matters because HACCP assumes all of it is already there. A hazard analysis assumes general conditions are controlled, so the plan can concentrate on the few steps where a hazard must be eliminated or reduced. Remove the conditions and hazards the environment should have handled arrive at the critical control point instead, leaving a metal detector to carry the weight of a drain running the wrong way.

Commercially, GMP is what a customer tests first, because it is the part they can see. A retail technologist forms a judgement in the first fifteen minutes, and it decides supplier approval and the technical stage of a tender. Sites call for a GMP audit when approval is pending, when a tender demands proof of hygiene control, after a complaint, or before a certification project.

There is a legal floor beneath this. The general hygiene requirements for food premises, the transport of food and related matters are set out in R638 of 22 June 2018, published in Government Gazette 41730 under the Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972. It requires premises to hold a valid certificate of acceptability from the local authority, and sets requirements for premises, facilities, food handlers, protective clothing and vehicles. A business that cannot show hygiene control has a legal problem before a commercial one.

What most GMP audits miss, and what ASC does instead

The typical GMP audit on offer is a downloadable checklist walked at speed on a quiet day, ending in a percentage. The checklist is generic and mapped to no published requirement, so the score is a percentage of nothing in particular, and nobody can say which clause a finding was raised against.

Timing is the second failure. An audit run while the line is down measures housekeeping, not manufacturing practice. Hygiene disciplines appear only under production pressure: whether hands are washed after the waste bin is handled at a changeover, whether the sanitiser is still at concentration late in a shift, whether zone doors are propped open when the room warms.

The third failure is that a checklist inspects a state and ignores a design property. That property is zoning and product flow, which is why a spotless site can still be unsafe. Cleanliness is a condition on the day; flow is built into the layout and repeats every shift. If air moves from raw materials into a ready to eat room, if a drain runs from high care through a lower risk zone, if staff cross back from the raw side without a clothing change, if waste leaves through the door packaging enters, the site recontaminates itself on a schedule.

ASC audits against a basis printed on the front of the report: R638, the Codex General Principles of Food Hygiene, the prerequisite requirements described in ISO 22002-1, and any customer standard you hold. The audit follows ISO 19011, so findings are evidence based, traceable to a requirement and ranked by risk rather than counted. Scoring is section by section against that clause set with the weighting written down, so the same sections can be re scored honestly next time. ASC issues no letter grade or star rating, because those imply an accredited scheme and none exists.

Key facts at a glance

Good manufacturing practice covers the building fabric, services, equipment design, maintenance, calibration, cleaning, personal hygiene, storage, waste, pest control and product flow, not only cleaning routines and protective clothing.
HACCP is built on the assumption that good manufacturing practice is already in place, which is why a hazard analysis carried out on a site with weak prerequisite programmes tends to understate risk.
In South Africa the general hygiene requirements for food premises, the transport of food and related matters are set out in R638 of 22 June 2018, published in Government Gazette 41730 under the Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972.
R638 requires food premises to hold a valid certificate of acceptability issued by the local authority, and it sets requirements for the premises, the facilities on them, food handlers, protective clothing and the transport of food.
An ASC good manufacturing practice audit is generally one day on site, with the written report issued about a week later.
ASC audits are conducted in line with ISO 19011, the international guidelines for auditing management systems, so findings are evidence based and traceable to a stated requirement.
ASC Food Safety Consultants is not a certification body and does not certify a management system, because the certification decision belongs to an accredited certification body after its own third party audit.
Prerequisite programme requirements for food manufacturing are described in ISO 22002-1 and in the Codex General Principles of Food Hygiene, which give an auditor a published basis for a GMP audit rather than an in house checklist.

When a business calls ASC in

  • A customer has made supplier approval conditional on evidence of hygiene control, and you want an independent view first.
  • You are bidding for a tender where an internal assurance of good order will not survive the technical evaluation.
  • A complaint, a foreign body incident or a recall has raised questions about conditions on the floor.
  • A certification project is about to start, and unresolved GMP failures would resurface as nonconformances at the certification audit.
  • You are applying for or renewing a certificate of acceptability, or an environmental health practitioner has raised findings under R638.
  • You have commissioned a new line or moved buildings, and the layout should be tested against hygienic design and flow.

How ASC does the work

1

The perimeter, the building fabric and the overheads

The audit starts outside, because much of what fails inside arrives from the yard: site security, standing water and vegetation against the walls, waste and effluent points, gaps under external doors, unscreened openings, and whether loading bays protect product.

Inside, floors are checked for coving, falls, ponding and the joints at equipment plinths, walls for impact damage and unsealed penetrations, overheads for condensation above open product, dust on ducting and anything mounted over a line that can drop. Lighting is checked for shatter protection of fittings, insect killers, windows, dials and gauges, and whether the glass register still matches the room.

2

Drains, air and water, the services that move contamination

Drains are audited for direction, not only cleanliness. Effluent should run from a cleaner zone toward a less clean one and never the reverse, and should not cross an open product area. ASC checks falls, trapped gullies, backflow protection, and whether hosing near open drains creates the aerosol that spreads Listeria round a wet room.

Air is assessed for capacity, filtration, duct condition, condensation and direction of movement between zones, which should run from higher hygiene areas toward lower ones. Where a site claims positive pressure in high care, the audit looks for evidence it is monitored and survives the doors being used. Water is checked against the drinking water specification in SANS 241, with testing frequency, results on file, and the treatment of ice and steam.

3

Equipment design, maintenance and calibration

Equipment is assessed for cleanability first: dead legs and unreachable voids, hollow rollers and open tubing, contact surfaces that cannot be reached without tools, bearings lubricated over product, rust, perished seals and cracked belting. Maintenance is then audited as a hazard in its own right, the part sites underestimate: repairs over open product, fixes held with tape or wire, swarf left after drilling, lubricant assumed rather than specified, and no hygiene release before restart.

Calibration covers the instruments food safety decisions rest on: probes and loggers, cook controllers, metal detectors, scales for allergen weighing, and pH and water activity meters where formulation controls a hazard. The audit checks frequency, traceability to a recognised reference, and the rule for product made since the last good result when an instrument reads out of tolerance.

4

Cleaning and sanitation, tested rather than assumed

Most sites have cleaning schedules. Fewer can show the cleaning works. ASC audits the instructions for the detail that decides whether the chemistry has a chance: the chemical named, the dilution and how it is achieved, water temperature, contact time and mechanical action. A sanitiser dosed at half concentration, or wiped off before its contact time elapses, has sanitised nothing.

The audit covers dosing equipment and its verification, colour coding between zones and between raw and ready to eat, and chemicals held in a locked segregated store. Verification is where it gets specific: pre start inspection by a named person, protein swabs or ATP readings against limits set for the surface tested, and the action taken on a failure. No failures on record for a long period usually means the limits are generous.

5

People, hygiene disciplines and everyone else who walks in

Personal hygiene is audited as practice under production pressure, not as a policy on a wall: changing room layout and whether it forces the correct sequence, protective clothing laundered under control rather than at home where the risk cannot be verified, hair, beard and headwear coverage, jewellery rules and how they are enforced, and hand wash stations where people need them, with hands free operation and hygienic drying.

Health screening is assessed against R638 and practical sense: declarations on employment, reporting of illness, exclusion for the relevant symptoms, and a documented return to work rule after gastrointestinal illness. Wounds are covered with detectable dressings that are issued and accounted for. Visitors and contractors get the same scrutiny, because they most often reach the floor without induction and with unrecorded tools.

6

Receiving, storage, segregation, waste, pests and dispatch

Goods receiving is audited as a control point, not a formality: vehicle inspection on arrival, temperature checks with the probe used correctly, wet or damaged packaging, pest activity in incoming material, and what happens to a load that fails. Rejection is only a control if someone is authorised to reject without permission from sales.

Storage is checked for separation of raw from ready to eat, allergens held apart and below other stock, packaging protected in its own area, chemicals stored away from food entirely, stock rotation enforced rather than assumed, and chiller alarms someone answers at night. Waste is followed from bin to refuse area, including whether waste and food share a doorway. Pest management is judged on whether the contractor’s recommendations were acted on or filed, and dispatch closes the loop with vehicle hygiene inspection before loading.

7

Foreign body control, glass and hard plastic, and allergens

Foreign body control is audited as a layered system, not a single detector: exclusion at the perimeter and at line level, sieves, filters and magnets with defined mesh or gauss and a check frequency, control of knives and small tools, and control of pallets, staples and cardboard. Where metal detection or X ray is used, the audit examines test piece sizes, test frequency, the response to a failed test, and whether the reject fail safe is proven. Glass and hard plastic control needs a register that matches the room and a breakage procedure people can follow at two in the morning.

Allergen segregation is a physical and human control before it is a labelling one: how allergens are stored, dedicated or identified equipment, scheduling that runs allergen bearing product last where segregation is impossible, validation of the changeover clean, and whether the label declaration matches the floor.

How ASC helps, in practice

These are illustrative composites. They name no client and report no measured outcome.

The spotless factory that kept failing swabs

A chilled foods manufacturer had a strong cleaning team, yet swabs kept returning positives near packing.

ASC audited during production and mapped air, drain and people flow. Drains from raw preparation ran toward packing, and packing sat at negative pressure because a new extraction unit had never been balanced. Cleaning was not the problem. Direction was.

The report separated hygiene practice from hygienic design and put air balancing and drainage ahead of more cleaning.

The tender that hinged on the yard

A bakery preparing a national food service submission wanted an independent GMP audit before the customer’s visit.

Internal disciplines were sound, but the yard told a different story: a refuse area without drainage, a gap under a delivery door, unscreened ventilation openings, and pest monitors that had recorded activity for months with the contractor’s recommendations unactioned.

The bakery received a sequenced list of building and contractor actions, and a section score to show at the follow up audit.

The certification project that started too high

A processor was drafting a management system, but the site had never been assessed against basic hygiene requirements or R638.

ASC ran a GMP audit first. Findings included maintenance over open product with no hygiene release, cleaning instructions with no contact time or concentration, and a glass register that did not match the room.

The gaps were closed first, so the system described the floor as it was rather than as the manual hoped.

What you receive

Deliverable What it contains
GMP audit report Findings area by area, each raised against the requirement it breaches, with photographs.
Section scoring A score for each section of the declared basis, with the weighting stated, so it can be re scored next time.
Risk ranked action list Findings ranked by food safety risk and legal exposure, with a correction, owner and date.
Zoning and flow observations How product, people, waste, packaging, air and water move, and the crossing points created.
Closing meeting record What was presented to management, what was accepted and what was disputed.
Verification visit An optional shorter return visit confirming closed actions have held under normal production.

The rest of the ASC audit programme

A GMP audit is usually the first of several. These are the services sites combine with it.

Who this work suits

ASC audits good manufacturing practice across South African food production: bakeries and confectionery, dairy and beverage plants, meat and poultry processing, chilled prepared and ready meal manufacturers, fruit and vegetable packhouses, spice and ingredient blenders, bottled water plants, cold stores, contract catering, and retail in store manufacturing.

Work is delivered from Gqeberha, formerly Port Elizabeth, in Nelson Mandela Bay in the Eastern Cape, with teams in Johannesburg and Cape Town and on site work in Durban and across South Africa. Auditors are practitioners who have run production and quality functions, and the report is written so operations, maintenance and technical managers each find their own work in it. ASC audits are led by lead auditors registered with SAATCA, Exemplar Global and IRCA. ASC Food Safety Consultants is SAATCA registered, a FoodBev SETA Accredited Provider No. 587/00337/1900. ASC Consultants SA is also a member of the Sustainability Initiative of South Africa, membership number 20240910 112270.

Where ASC stops

ASC Food Safety Consultants is not a certification body and never certifies a management system. A GMP audit is an independent assessment for your own use and for your customers, producing a report, a section score and an action list, not scheme certification. The certification decision belongs to an accredited certification body after its own third party audit.

Fixing what the audit finds is separate work. ASC’s HACCP and GMP implementation consulting takes prerequisite programmes, hygienic design corrections and documented controls from concept to working practice. Where the question is whether a full management system performs rather than whether the conditions are right, that belongs with FSMS audits.

Frequently asked questions

What is the difference between a GMP audit and a HACCP audit?

A HACCP audit tests the hazard analysis and the plan built on it: the hazards identified, the critical control points chosen, and whether critical limits are validated and monitored. A GMP audit tests the conditions that plan assumes are already in place.

Do we get a GMP certificate at the end of the audit?

No. ASC issues a written report, section scoring and a risk ranked action list, and that is what you show a customer. There is no accredited GMP certification scheme behind a consultant’s letterhead, so treat any offer of one with care.

How long does the audit take and when does the report arrive?

Generally one day on site, with the written report following about a week later. High level findings are discussed with management at the closing meeting on the day. Large sites, and sites running several shifts, may need more time.

Should the audit happen while we are in production?

Yes, for most of it. Hygiene disciplines become visible only under production pressure, so ASC audits with the line running and, where it matters, observes part of a cleaning shift and a start up.

Does a GMP audit satisfy the local authority for a certificate of acceptability?

No. It is issued by the local authority under R638 of 22 June 2018 after its own inspection, and no private audit replaces that. A GMP audit shows what the inspection is likely to find and turns R638 into specific corrections on your site.

How do we track improvement between audits without inventing a grading system?

By keeping the basis and the weighting fixed and scoring the same sections every time, so movement is a real comparison. ASC will not award a grade, star or badge implying an accredited scheme stands behind it.

Book a GMP audit and see what your customer will see

An ASC auditor spends a day on your site while it is running, and about a week later you have an evidence based report, a defensible section score and a risk ranked action list. Tell ASC the site and the product and the visit can be scoped from there.

Not ready for a quote? Use Where Do I Start, or book a virtual consultation.

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