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Change in quality concepts

Pradeep Y Sarode
Wednesday, March 22, 2017, 08:00 Hrs  [IST]

The current good manufacturing practices focus on examination and documentation of variability in manufacturing processes, and so actually reinforce the 'quality by inspection' approach. As per US FDA, quality units are independent of production and suppose to report directly to the CEO to avoid pressure for compromising on quality. Management with blind faith considers the quality professionals as expert adviser.

Unfortunately some quality professionals are highly risk-averse due to fear of entry of substandard products in market. They became stubborn, over conscious, always resist changes and rely on additional checking, oversight, and paperwork-based compliance. This result into rigid requirement/procedure based on their own perceptions. Perceptions vary from person to person so requirements also vary.

Majority of quality heads behave like police with viewing others as thieves based on incident-driven and case-oriented attitudes. This role of quality assurance as a police was dictated by the respective QA heads perception/misconception about quality concepts Their GMP practices are predominantly or exclusively based on the actual or threatened use of QA’s coercive authority. They train their subordinate to behave like police with demand of bringing at least one non compliance daily. To complete the target, non-compliance incidences are created intentionally ex shortage of tubes in carton in FG inspection of packed goods. This build suspicious mindset in quality team that operational peoples are always against quality and not capable to produce quality products. They judiciously use their authority for compliances even though they lack knowledge of that subject & some misuses their authority to teach lessons to the operational people or create positive image in front of top management. In- fact many quality professionals enjoy in stopping the operations or intentionally allowing the operations which can lead to crisis without risk analysis. Some QA people highlight frequent minor non compliances to show that only quality unit is working effectively. This indirectly influences operational people’s attitudes, values, and beliefs in-turn disturbs the morale of shop floor peoples who are suppose to build the quality in product.

Example of incidences affecting operational people morale are in a product of 15 gm Diclofenace gel, the quality assurance persons insisted to keep the fill weight NLT 16 gm without doing risk analysis which resulted in yield of 92 per cent, insisting on iron weight as std weight for high accuracy Metler weighing balances, strict implementation of doers checkers concept and no dispatch until BMR review but deviating from same when QA person is not available etc. In another incidence the product was kept on hold as microbial content was crossing the alert limit production unit has been taken on task but cause found was Maize starch, released by QC based on random sampling instead of 100 per cent sampling as per SOP.

This has a substantial impact on the correct understanding of quality concepts by shop floor employees. Quality culture on the shop floor in many companies is underdeveloped, with quality often seen as the responsibility of the quality unit only. The implication here is that being labelled as thief, Operational people hide some of the information/incidences, avoid giving suggestions and taking parts in improvement projects, taking short cuts diplomatically etc. It becomes a vicious cycle in terms of operations peoples not suggesting any changes in future.

Changing role of QA
The persistence of chor-police culture between the quality and operational professional is a serious obstacle for efficiency and effectiveness of organisation to produce quality goods consistently. Unfortunately knowing or unknowingly many management views such conflicts as productive conflicts, supports such concepts without analysing the facts and calculating risks. This is detrimental to the overall system as a whole. Many tasks performed by production, engineering, technical services, human resources, etc. are assigned to the quality unit which may not have the capability of performing these tasks adequately. The basic philosophy of these GMPs i. e. control inspects, don't trust production, is out of date. Only knowing the regulations, following the SOPs, auditing for gap analysis and focusing on compliance will not be enough. In September 2003, the Wall Street Journal published an article informing the world that pharmaceutical “manufacturing techniques lag far behind those of potato-chip and laundry-soap makers.” In that same article it correlated the rise in recalls with quality problems and noted that despite fines in excess of US$ 500 mn for manufacturing failures, acceptable levels of quality were not being achieved. US FDA and other regulatory bodies are acknowledging that the industry has fallen behind other sectors in terms of efficiency and quality. It proves that in spite of having separate QA department with number of people working towards inspection, compliance and documentation neither we improved in quality nor our manufacturing efficiency/productivity is improved. We are far behind when we compare ourselves with other industries. Even as on today, majority of drug manufacturers’ processes are at 2.5 to 3 Sigma compared to 6 Sigma in automobile, semiconductor and aerospace industries. Functional quality processes (built-in quality) in pharma is often fairly low. Automobiles were able to achieve the improvement in quality by following Toyota Production Systems and semiconductor performance levels were achieved by heeding the 1950 advice of W. E. Deming, the father of modern quality. Consequently, the FDA’s vision for pharmaceutical manufacturing in the 21st Century builds on fundamentals of quality which was followed by automobile, semiconductor and aerospace industries.

US FDA new initiatives are increasingly driving the industry toward preventive rather than the control- and audit-based approach Since then, the FDA, the International Conference on Harmonization (ICH) and the industry have been extremely active, working together to shape the new quality requirements and standards. They began to endorse a “quality by design model” that contrasts with the industry’s historical “quality by test” results approach. The publication of ICH Q10, Pharmaceutical Quality System, in 2009, emphasizes the responsibility of senior management for the quality system; it is a big step in modernizing our thinking about quality.  Today’s philosophy of quality is that the producers must be responsible for the quality of their work, the product. This is achieved by a robust production process design and validation, and well-trained personnel who take responsibility for the quality of their work. In other words, pharmaceutical development and manufacturing in the future will be synonymous with “quality by design,” scientific manufacturing and risk-based regulatory oversight. Such disruptions of the organizational equilibrium might not be enthusiastically received; efforts to change not only routines, but also the rules of the game are likely to confront resistance.

Unfortunately much management still rely on the quality unit for establishing and managing the PQS. Quality as expected by PQS is an activity in which shop floor employees should engage at their own initiative, rather than in response to specific directive/instructions. But whether and to what extent shop floor employees engage in quality matters would be affected by their attitudes toward quality improvement. The prevalent line staff conflicts of production/engineering and QA and their attitudes towards each other will result in failure of establishing the effective PQS. Hence the company management must take responsibility of implementation of PQS. Knowledgeable individuals at the operational management level i.e. manufacturing engineers, line management, and the general workforce are needed to take command of each constituent part of the QMS ensuring that their respective parts of the quality system are relevant, compliant, and efficiently integrated with the other parts of the QMS and participate in proactively improving process capability.

Quality departments should move away from their old “policeman” role of inspection and should play a more integrated role in the design, process improver and quality promoter. The change in mindsets required is from a “they” to a “we” approach, problem-solver to a preventer approach, enforcer to an advocate approach, Conformity to a continuous improvement approach.

They should at least facilitate the change by working closely with manufacturing operations, understand about the manufacturing processes and challenges faced by production workers and guide them as associates. They must understand how to interpret international regulations properly shall guide/train all others to bring common understandings about processes. They should think of quality as the processes, procedures and culture that permeate an organization  enabling it to consistently produce high-quality pharmaceutical products.

(Author is General Manager, Laboratories Griffon Pvt Ltd, Mumbai)


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