Scaling Up the Organization as it Grows 7 – Pharma Veterans’ Blog Post #527 by Asrar Qureshi

Scaling Up the Organization as it Grows 7 – Pharma Veterans’ Blog Post #527 by Asrar Qureshi

Dear Colleagues!  This is Pharma Veterans’ Blog Post #527. Pharma Veterans welcome sharing of knowledge and wisdom by Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on WordPress, the top blog site. Please email to asrar@asrarqureshi.com for publishing your contributions here.

Continued from Previous……

Product and Service Development

We continue to discuss the challenges in scaling up of products and/or services.

Quality Control – is a critical area to look for while scaling up. It is easy to understand that maintaining quality of smaller volumes is easier than doing the same for larger volumes. It is also understood that increase in demand would put pressure on delivery time also, which in turn may create a stress on quality.

Three challenges/ areas-to-handle may be considered regarding quality control during scaling up.

One, is the capacity of quality control department. Rather than just putting pressure to ‘do more’, capacity analysis should be done clearly. Addition of staff may be one way of adding capacity. Reviewing, standardizing, and streamlining quality control procedures should also be considered. Adding technology must be considered wherever applicable. Pakistani businesses suffer hugely on account of refusal to embrace technology. One factor is the availability of cheap labor, the other may be ambivalence about technology. Pharma industry is a classical example where many smaller companies try hard not to invest on technology. If at all they do, it would be under severe duress and coercion.

Two, is the capability of quality control staff. DRAP – Drug Regulatory Authority Pakistan, had put up the condition that the Head of Quality Control must have at least ten years of work experience. They put up similar condition for the Head of Production. The local industry pursued the regulator aggressively citing shortage of such staff and its high cost. They were finally able to get the term reduced to six years. It is ironic that the Head of Production must still have ten years’ experience. It may be inferred that the local entrepreneurs are interested in production but not in maintaining quality. This is the situation in Pharma which is a highly regulated industry. What can we say about the unregulated industries? During my visits to various other industries such as printing, packaging, plastics etc., I have seen that quality control is virtually non-existent.

Three, is the constant upgrading of quality parameters. New information is continuously pouring in due to research. Safety considerations are being upgraded and new parameters are added. This is the greyest area in our local scenario. Barring predominantly export-oriented industries, the local entrepreneur prefers to follow outdated quality control procedures and parameters. The primary motive is cost saving. 

While scaling up, quality control must be scaled up proportionately.

Quality Assurance – while quality control mainly deals with the product, the Quality Assurance is responsible for laying out and ensuring compliance of quality-related guidelines throughout the organization, across all functions. Basically, Quality Assurance is the parent function, of which Quality Control is the arm dealing with the quality of the product.

Quality Assurance did not exist until recently. Where it did exist, it was mixed up with Quality Control and the term was used interchangeably for ensuring product quality. The ISO certifications brought the Quality Assurance function in the limelight. They insisted on it as the integral function for certification. The ISO certified companies now have a quality assurance function, or some semblance of it. In most cases, someone from quality control has been nominated as quality assurance person to fulfill the requirement.

Where does quality start from? The latest thinking is QbD – Quality by Design. It means that quality must be built into the design, or the foundation, not just of the building, but all functions. Secondly, it is now clearly understood that quality is the responsibility of everyone in the organization, not just the quality control department, hence the need for all-encompassing quality assurance function.

Our biggest challenge in Pakistan lies in the fact that we are generally quality-averse, rather than being quality oriented. This is evident in most of the things that we see on the market. Our markets are filled with low-quality produce and products which are sold with impunity. The sellers are not shy to sell these and the buyers are not reluctant to buy these. Having said that, quality must still be talked, kept in focus, and practiced.

Delivery – is another area where huge transformation has taken place. The time to deliver, way to deliver and the products to deliver have all changed for better. Online shopping and home delivery has grown exponentially. While scaling up, this comes up as another challenging area. 

Delivering promised quality and quantity is critical to building and retaining customer base. You may cheat a customer once, but not always. We have seen improvement on this count. Several suppliers have established their credibility as quality suppliers. Quality Assurance and Quality Control shall make certain that quality deliveries are made without exception.

Delivery time is the other area to focus upon. Most suppliers commit a time frame for delivery, and it is done. Food deliverers are promising by minutes. When you place an order, they would give time in minutes for delivery. It has also become an area of competition, as to who delivers faster. 

Under-committing and overdelivering – telling four months and delivering in three months, like our car makers do, is equally bad as compared to overcommitting and underdelivering – promising three days and taking five days. The time to delivery should be carefully calculated and strictly adhered to.

To be Continued……

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