The important people factor

Posted: 3 May 2005 | Maggie Duke, QA Advisor and Expert in Hygienic Engineering and GMP, Nestle S.A | No comments yet

During the last 25 years, there has been a steady evolution in the way the food industry organised itself to ensure delivery of safe and consistent quality food to the consumer.

In the late 1970s, it was still common to see extensive laboratories in factories with large numbers of people analysing raw materials and finished products before their release to production and distribution, respectively. The QC managers rarely left their domain and were not commonly seen in process areas.

During the last 25 years, there has been a steady evolution in the way the food industry organised itself to ensure delivery of safe and consistent quality food to the consumer. In the late 1970s, it was still common to see extensive laboratories in factories with large numbers of people analysing raw materials and finished products before their release to production and distribution, respectively. The QC managers rarely left their domain and were not commonly seen in process areas.

During the last 25 years, there has been a steady evolution in the way the food industry organised itself to ensure delivery of safe and consistent quality food to the consumer.

In the late 1970s, it was still common to see extensive laboratories in factories with large numbers of people analysing raw materials and finished products before their release to production and distribution, respectively. The QC managers rarely left their domain and were not commonly seen in process areas.

The 1980s, however, witnessed a clear swing from quality control to quality assurance. Systems such as HACCP required that prevention preceded control. Prevention also meant ensuring that a solid base of GMP existed. This entailed the engagement of the operators in efforts to ensure quality.

Central factory laboratories began to decrease in size. Instead, satellite line laboratories emerged where operators could carry out analyses themselves and release intermediary products to the next step of the process.

The QA managers also had a new role. Their presence was increasingly necessary in process areas, in order to oversee the preventive measures and the standard and calibration of the output of the line labs.

In the 1990s, increasingly greater responsibilities were given to the operators. Automation also allowed for more accurate adhesion to standard operating procedures.

Currently, there are still QA managers in the factory, but they are part of the factory team that must ensure all is in place at the line to maintain quality.

In addition, quality is now being managed throughout the supply chain – not only in the factory. Quality experts or advisors of head offices of companies must ensure that all systems are in place for prevention. This is often carried out during more formal audits.

Essential tools of quality advisors

Systems alone cannot ensure that product quality is safe and consistent. This is why the task of a quality advisor must not be limited to checking systems. With the practical experience that can only come from working in factories, they must be able to see much further than the systems. They must know how to use their five senses and not just laboratory analytical tools.

There is nothing less costly in investment than using the five senses:

  • Eyes – for visual examination of cleanliness, maintenance requirements and, of course, observing people
  • Nose – to smell where residues could be accumulating, for example where a drain is dirty with stagnating water
  • Ears – to hear where a machine is not functioning properly; where there is abnormal metal-to-metal friction or where a vacuum is not pulling correctly
  • Touch – to feel a surface that has become rough, cracked and difficult to clean; to explore inside welded pipes for rough finishing and to sense airflows
  • Taste – for rapid identification of chlorinated water; fast evaluation of culinary steam quality or to investigate if insufficient rinsing after cleaning has left residues that can contaminate product and cause off flavours

There is one other use of the sense of hearing that is critical: listening to others. Listening is part of the ability to communicate. This must happen at all levels in the factory. It enables a quality advisor or expert to appreciate if there is a true culture of GMP, which is the basis for the sustainability of quality.

Advising on quality in the factory

On entering a factory, quality advisors should divide their attention between two aspects of factory life: its features and its people. Both impact on GMP, but too often more time is spent on details themselves and not on what makes the factory run from day-to-day.

Generally, the first things observed are:

  • The state of the building
  • The housekeeping of the process area
  • The extent and appearance of the process lines
  • The status of cleaning and maintenance

A side excursion from the process area can lead to the industrial services area, including electrical systems, water treatments, steam production and air handling. Each of these are essential arteries feeding the process lines and should not be ignored in any factory visit.

All of the above are important and without an appropriate application of standard operating procedures for processing and hygienic engineering, it is difficult to maintain desired quality standards.

Additionally, a visit to the QA department is often solicited for a review of data; of HACCP documents and for a tasting of current product samples – from the market place and maybe some from development. Such quality evaluations are indicators of the effective functioning of preventive measures and operating procedures.

Should the visit stop there, however, then the second fundamental part of factory life is missed. Maintaining and sustaining all of these GMPs is the task of the factory staff, including operators, fitters, maintenance teams, electricians and cleaners. These people are the stakeholders of all that supports factory activities, ensuring that safe and consistent quality products leave the warehouse, on their way to the consumers.

People ensure quality, not systems

The involvement of people looking after the process lines and all associated services is the key factor in ensuring that quality is maintained and, in fact, continuously improved.

Therefore, the task of any QA advisor must include interaction with the people on the line. The latter are looking after quality on a daily basis and the status of their behaviour, attitude and interest in their work are equally important as indicators – as is the data from the samples etc.

Quality advisors should look at:

  • Trends of line sample analysis after cleaning
  • The number of products rejected by the metal detector
  • Quantities of product out of specification for colour, taste or humidity

They should also follow up on any deviations from the normal situation, discussing ideas for preventative action with both managers and operators.

Examples can be seen in the following:

  • Trends of concern following cleaning: difficult to clean points should be studied with the factory team. An expert on cleaning would also be useful to make a more detailed analysis of the problems
  • Larger numbers of products rejected due to metal contamination: a plan should be developed with the factory team to search for sources of the problem. Possible interference with metal detection operation may also require investigation
  • Out-of-specification products: this may require an advisor to organise a team meeting with production and process engineering in order to identify where process parameters need changing or better control. Operators could also provide the reason for such deviations

Added value for sustainability

Production of safe and consistent goods requires empowered people who know what matters; who are releasing process steps according to their responsibility and releasing equipment after cleaning and maintenance. Quality advisors must guide the factory team into solving their problems themselves and perhaps giving some input where more experience on a subject is necessary.

After such coaching, people will be more alert to deviations and feel that they have a responsibility to highlight a potential problem before it happens. They must feel that they add value whatever their task and they should have a passion for what they do.

One entity – factory appearance and people

In fact, it is clear that a quality advisor who is successful in their role sees the above aspects – factory appearance and people – at the same time and not as two separate entities. Quality of workplace and quality of people go hand-in-hand.

For example:

  • Inspecting the maintenance of the building should be carried out with the assistance of engineers who can provide input on any weaker areas that are noticed. The improvement may be made with an investment allocation for the following year
  • If poor housekeeping of the process area is noticed, the advisor should check whether operators are having difficulties arranging some items, or if there is a lack of pride in the area’s appearance
  • In the event that cleaning and maintenance of an installation is not acceptable, the advisor should spend time with cleaning teams and maintenance staff to check that equipment as installed facilitates such activities

Responsible managers should also oversee these activities and provide the necessary tools.

Advisor or auditor

There are clearly situations where more formal audits are essential. However, problems can arise when audits are only carried out with checklists and, in some cases, with people lacking a broad and practical experience of the food industry. Check lists can limit the scope of observation. The person using such a document may not see outside the points that must be controlled on the list.

The following are examples of typical points on a checklist and their limits:

  • Point to check: Is water quality acceptable for processing?

Limitation: If the auditor only looks at the water quality and checks that it is potable, then potential problems could be missed. For example, a true expert would know in a chocolate factory to check the tempering water. In a factory using water as an ingredient for infant products, the product expert would expect to see additional analysis records on water content of heavy metals and other residues linked to the product specification. The chilled water quality can also impact product quality where it is used as a cooling agent

  • Point to check: Is processing of dry products under control with no wet washing?

Limitation: The answer could easily be ‘yes’ with the assumption that, with no wet washing, there would be no risk of growth. An expert, however, would know to look deeply into the known risks, for example opening a dry blender and looking for signs of condensation – points where water activity could rise to a level permitting growth

  • Points to check: Do monitoring schemes and standard operating procedures exist by the line?

Limitation: The answer can be ‘yes’, but this observation cannot ensure that the monitoring schemes are being used or even understood. Likewise, standard operating procedures for cleaning can be dependent on the equipment, but this does not prevent cleaners from using the wrong amount of chemicals. The correct application of such procedures can only be checked if the audit covers 24 hours of factory operation

An audit can provide a snap shot. But the output becomes really useful when the results lead to a more intensive study by the quality advisor or expert of any signs or points on the checklist indicating potential problems.

Every factory has a life of its own. To be proactively preventive, a follow-up of an audit must also probe into the heart of the factory and include observations particular to that operation and its products – not forgetting the attitude of the factory team.

In conclusion, although audits are one of the recognised quality management tools, they are only really useful when accompanied by a follow-up.

In many cases it is better to use the gap assessment approach. For gap assessments, in addition to highlighting the problems as gaps, these are given priority ratings for action and advice is given for improvements.

Ideal approach for a quality advisor

An ideal approach is to refer to the objective of such visits. The main aim is to help ensure sustainability of quality through continuous application of GMPs. After a visit in which actions are advised and implemented, the efforts must continue. It would be wrong if the factory only waited for the next visit of an advisor to be assisted with other points for action. The factory must adopt a mode of continuous improvement, in which all of the stakeholders – the operators – must be involved.

A quality advisor who ‘opens up’, observes and gives feedback to everyone and can help the factory team achieve this longer-term aim. They can assist by launching some of the initiatives, but in a very pragmatic way with coaching at the line. The following steps are successful ways of ‘opening up’:

‘Open up’ some equipment

Operators and mechanics will never forget when equipment is opened up with their help and they see:

  • Hollow bodies with residues
  • Friction causing metal residues
  • Loose or broken seals leading to foreign material
  • Piping with poor internal welding difficult to clean
  • Dead ends still containing residues, after CIP
  • Excess lubricants dripping into product
  • Paint chip(s) falling into exposed product
  • Infiltration with potential sources of contamination entering a dry area

‘Open up’ all satellite and service elements

  • Go with production and engineers responsible for such areas to open up air handling units, water tanks and small cleaning rooms

‘Open up’ to people and involve them in prevention

  • During the two activities outlined above, watch the people and listen to their input and problems about difficulties to maintain and clean, then share ideas for solutions
  • Temporary engineering measures with tape, wedges of cardboard and string are faults, but they are also indications that a more permanent corrective measure must be found

‘Open up’ on preventive steps to everyone

  • Where possible, all factory visits should end with an information session for all. Beginning with encouragement on improvements seen, discussion can follow about faults observed with ideas for corrections
  • Such sessions are a very proactive way to train the factory team
  • Involve local suppliers, agricultural services, purchasing and warehousing


The tasks of a quality advisor are not restricted to taking a snapshot view of the factory and looking at records. In fact, their roles require significant interaction – to be both helpful and constructive. This involves crossing cultures, understanding people and, in turn, helping them understand what is important to sustain GMP and quality. The passion of the quality advisor must be bestowed on everyone in the factory, which will ensure sustainability and continuous improvement.

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