**5.1 Personnel**

We should not forget that the PHEC-19 focuses on people because persons diffuse the virus. Neither diseased nor infected persons should be allowed into the manufacturing premises [1].

This means that absenteeism can increase and diminish without prior notice the work force at disposal. It is necessary to ensure that this will not affect the quality standard of production.

#### **5.2 Preventive measures**

They can have an indirect effect on manufacturing. On one side the need to limit personnel and to isolate them, can provoke a shortage of personnel, as discussed in the previous bullet. On the other, preventive measures might affect production processes in terms of increased duration (because supplementary sanitization requirements or personnel controls) or modified schedules (e.g. because of lack of catering services).

#### **5.3 Supply of materials, reagents and consumables**

Items and utilities supplied to a manufacturing plant can be affected by PHEC-19 and be unavailable or suffer losses of quality.

In fact, as shown in **Table 4**, the problems derived from PHEC-19 can belong to three categories:



#### **Table 4.**

*PHA of supply of materials, chemicals, products, consumables, etc.*

Thus, it is necessary to evaluate in detail each one of these situations to see if they could really affect the quality of the products manufactured in the plant. Changes in attributes could require additional controls to understand their possible effects in properties, stability, etc. The lack of supplies could unleash a chain of shortages.

A regular exchange of information between supplier and manufacturer is essential. The former should understand that changes are likely to affect the manufactured products. The latter should be informed about changes and be aware to detect changes.

#### **5.4 Supply of utilities**

We should also consider the possible effect of PHEC-19 on the supply of utilities such as electricity, water or gas, even if this is unlikely (**Table 5**).

#### **5.5 Premises and facilities**

In manufacturing plants where sanitization was already a product requirement, the new measures introduced by PHEC-19 do not purport sensible changes. They knew very well that persons are sources of contamination and acted accordingly (use of special attire, sanitization, health control, separation, training, etc.). They also had HVAC systems that controlled the quality of air by ventilation and filtration.

However, in other industrial branches the preventive measures can be more difficult to implement, because personnel is neither familiar nor trained in these procedures. They also do not have HVAC systems prepared for an adequate control of the air quality (**Table 6**).

Have the changes performed in the plant to implement preventive measures affected the approved operational procedures? If the answer is yes, are these changes likely to affect the quality of the products? Logically, the aim is to detect all


#### **Table 5.**

*PHA of supply of utilities.*


#### **Table 6.** *PHA of premises and facilities.*

changes, determine their effects and, if necessary, apply the necessary corrective and preventive measures.

In addition to operational changes, absenteeism and confinement measures may have altered the scheduled maintenance, calibration, commissioning, and qualification/validation programs. Here, cases can be very varied. Usually old equipment is well known and the effect of these alterations can be better assessed. This is not the case with newer equipment, which might require production under increased monitoring or simply, be left aside until situation improves.
