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This is a model-answer extract for a postgraduate-style pharmaceutical quality assignment. Section 1 compares Deming, Crosby and Juran and links their ideas to ICH Q10. Section 2 is a formal CAPA report for an out-of-specification (OOS) pH result in a 1,000 L batch of phosphate-buffered saline (PBS). Any figure not taken from an official source is marked “illustrative”.

Reviewed by: Aoife Ryan, Ph.D. in Environmental Science from the University of Limerick, proficient in Harvard referencing. The original task is on the quality gurus, ICH Q10 and CAPA report question page.

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Section 1: The quality gurus and their impact on modern pharmaceutical QMS

1.1 Core philosophies

Deming treated quality as a management problem. His 14 Points and the Plan-Do-Check-Act (PDCA) cycle place responsibility for quality on senior leaders, and he argued that most variation comes from the system rather than from the individual worker (Deming, 2000).

Crosby defined quality as conformance to requirements and set a performance standard of zero defects. His central message is that prevention is cheaper than inspection, and that the “price of nonconformance” (rework, scrap, investigations, lost batches) is what poor quality really costs (Crosby, 1979).

Juran defined quality as fitness for use and structured improvement through the Quality Trilogy of planning, control and improvement. He also popularised Pareto analysis, which separates the “vital few” causes from the “useful many” (Juran and De Feo, 2017).

1.2 Comparing the gurus on root causes

Deming and Crosby are closer than they first appear. Deming’s system view explains why defects recur; Crosby’s conformance view tells you what to write down so that a deviation is visible. Both reject “retrain the operator” as a final answer, which matters directly for Section 2.

1.3 Translation into cGMP and ICH Q10

ICH Q10 states that it is based on ISO quality concepts and complements regional GMP requirements (EMA, 2015, section 1.1). It sets three objectives: achieve product realisation, establish and maintain a state of control, and facilitate continual improvement (section 1.5). Knowledge management and quality risk management are its two enablers (section 1.6). The EU GMP Guide adopted the same structure in Chapter 1, which expects an appropriate level of root cause analysis for deviations and the identification of CAPAs (European Commission, 2013).

Evidence on impact is encouraging but cautious. An analysis of benchmarking data found higher quality-system scores after ICH Q10, although the authors state that causation cannot be proved (VanDuyse, Fulford and Bartlett, 2021). Calnan, O’Donnell and Greene (2013) argue that many companies had not yet transformed traditional quality systems several years after publication. A critical answer should therefore credit the framework while questioning how far it is applied.

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Section 2: CAPA report – OOS pH in a 1,000 L batch of PBS

2.1 Event description and scope

A 1,000 L batch of 1x PBS, used in downstream processing of a monoclonal antibody, tested at pH 7.9 against a specification of 7.4 ± 0.1. The batch is on QA hold. All investigation findings below are illustrative, because the report documents a hypothetical event. A typical PBS formulation contains 137 mM NaCl, 2.7 mM KCl, 10 mM Na₂HPO₄ and 1.8 mM KH₂PO₄ at pH 7.4 (Cold Spring Harbor Protocols, 2006).

2.2 Correction (immediate containment)

1. Keep the batch quarantined on QA hold and label the vessel “do not use”.
2. Open a deviation and a linked OOS investigation, following the phased approach in FDA (2022): a Phase I laboratory assessment, then a Phase II full-scale investigation if no laboratory error is found.
3. Retain the tested sample and run no retest until the laboratory check is complete; retesting must not be used to “test into compliance” (FDA, 2022).
4. Check whether any other PBS batch prepared with the same raw-material lots, the same pH meter or the same batch record revision is in use, and hold it pending review.

2.3 Root cause analysis

The team used an Ishikawa diagram across six branches (method, machine, material, measurement, environment, people), followed by a 5 Whys on the surviving hypothesis. Four scientific causes were tested against evidence.

Under the Henderson-Hasselbalch equation, pH changes with the logarithm of the base-to-acid phosphate ratio. A rise of 0.5 pH units therefore needs that ratio to increase by about 10^0.5, roughly three-fold, which is exactly what charging only one-third of the acidic (monobasic) salt would do. This is why the chemistry supports the ratio hypothesis and not the other three.

5 Whys (illustrative)

1. Why was the pH 7.9? Too little monobasic phosphate was in the batch.
2. Why was too little charged? The batch record stated a lower mass than the calculation requires.
3. Why did the batch record state it? A scale-up revision from 100 L to 1,000 L transcribed the monobasic mass incorrectly.
4. Why was it not caught? The revision was approved without an independent recalculation, and the weighing station only displayed the target, with no electronic limit check.
5. Why was there no check? The change-control procedure did not require verification of calculated quantities for buffer batch records.

Definitive root cause: a gap in change control for batch-record revisions, combined with a weighing step without automated verification, allowed an incorrect monobasic phosphate quantity to be issued. The operator followed the record as written, so “human error” is not accepted as the root cause: it describes the symptom, and the system condition is what must be corrected, consistent with the Deming and Crosby positions in Section 1.

2.4 Corrective action and batch disposition

• Disposition: reject the 1,000 L batch. Rework by adjusting pH is not part of the approved process, and a confirmed OOS result means the batch does not meet its specification (FDA, 2022). Do not release it for use.
• Correct the batch record: reissue it with the right monobasic mass, independently recalculated and signed by a second person.
• Extend the review: check every other buffer batch record revised in the same change to confirm none carries a similar calculation error.
• Optional learning study: a small-scale pH-adjustment trial under QA protocol, strictly for investigation and not for use in manufacture.

2.5 Preventive action

2.6 Effectiveness check

The CAPA stays open until the next 10 consecutive PBS batches meet pre-defined criteria. These are proposed, illustrative targets:

• All 10 batches within pH 7.4 ± 0.1, with no OOS result or deviation attributed to buffer preparation.
• Calculated-versus-weighed reconciliation completed on 100 per cent of batch records.
• Calibration slope within the laboratory’s acceptance range on every day of use.
• Results trended and presented at management review (EMA, 2015, section 3.2.4).

If any batch fails, the root cause is reopened and the CAPA is not closed. Closing on paper without data would contradict the improvement logic of PDCA.

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For a full written version of an assessment like this one, ask for a tailored essay writing service quote. You can also read the companion guide on how to write a CAPA report for an OOS pH deviation, and compare the style with a related science sample such as the toxicological review sample. A different ICH Q10 brief is on the ICH Q10 essay question page, and our approach is explained on the about us page.

References

Calnan, N., O’Donnell, K. and Greene, A. (2013) ‘Enabling ICH Q10 implementation – Part 1. Striving for excellence by embracing ICH Q8 and ICH Q9’, PDA Journal of Pharmaceutical Science and Technology, 67(6), pp. 581–600. doi:10.5731/pdajpst.2013.00940.

Cold Spring Harbor Protocols (2006) ‘Phosphate-buffered saline (PBS)’, Cold Spring Harbor Protocols, 2006(1). doi:10.1101/pdb.rec8247.

Crosby, P.B. (1979) Quality is free: the art of making quality certain. New York: McGraw-Hill.

Deming, W.E. (2000) Out of the crisis. Cambridge, MA: MIT Press.

European Commission (2013) EudraLex Volume 4 – EU guidelines for good manufacturing practice for medicinal products for human and veterinary use, Chapter 1: Pharmaceutical quality system. Available at: https://health.ec.europa.eu/system/files/2016-11/vol4-chap1_2013-01_en_0.pdf (Accessed: 21 October 2026).

European Medicines Agency (EMA) (2015) ICH guideline Q10 on pharmaceutical quality system, EMA/CHMP/ICH/214732/2007. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-guideline-q10-pharmaceutical-quality-system-step-5_en.pdf (Accessed: 21 October 2026).

European Medicines Agency (2023) ICH guideline Q9 (R1) on quality risk management, EMA/CHMP/ICH/24235/2006. Available at: https://www.ema.europa.eu/en/ich-q9-quality-risk-management (Accessed: 21 October 2026).

Food and Drug Administration (2022) Investigating out-of-specification (OOS) test results for pharmaceutical production: guidance for industry (Revision 1). Silver Spring, MD: FDA. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigating-out-specification-test-results-pharmaceutical-production (Accessed: 21 October 2026).

Juran, J.M. and De Feo, J.A. (eds.) (2017) Juran’s quality handbook: the complete guide to performance excellence. 7th edn. New York: McGraw-Hill.

VanDuyse, S.A., Fulford, M.J. and Bartlett, M.G. (2021) ‘ICH Q10 pharmaceutical quality system guidance: understanding its impact on pharmaceutical quality’, The AAPS Journal, 23(6), article 117. doi:10.1208/s12248-021-00657-y.